CKD 3b Research Articles

Impact of metformin on cardiovascular and kidney outcome based on kidney function status in type 2 diabetic patients: a multicentric, retrospective cohort study

Metformin is the primary treatment for type 2 diabetes mellitus (T2DM) due to its effectiveness in improving clinical outcomes in patients with preserved renal function, however, the evidence on the effectiveness of metformin in various renal functions is lacking. We performed a retrospective, multicenter, observational study used data of patients with T2DM obtained from three tertiary hospitals’ databases. Patients given metformin within run-in periods and with at least one additional prescription formed the metformin cohort. A control cohort comprised those prescribed oral hypoglycemic agents other than metformin and never subsequently received a metformin prescription within observation period. For patients without diabetic nephropathy (DN), the outcomes included events of DN, major adverse cardiovascular events (MACE), and major adverse kidney events (MAKE). After 1:1 propensity matching, 1994 individuals each were selected for the metformin and control cohorts among T2DM patients without baseline DN. The incidence rate ratios (IRR) for DN, MACEs, and MAKEs between cohorts were 1.06 (95% CI 0.96–1.17), 0.76 (0.64–0.92), and 0.45 (0.33–0.62), respectively. In cohorts with renal function of CKD 3A, 3B, and 4, summarized IRRs of MACEs and MAKEs were 0.70 (0.57–0.87) and 0.39 (0.35–0.43) in CKD 3A, 0.83 (0.74–0.93) and 0.44 (0.40–0.48) in CKD 3B, and 0.71 (0.60–0.85) and 0.45 (0.39–0.51) in CKD 4. Our research indicates that metformin use in T2DM patients across various renal functions consistently correlates with a decreased risk of overt DN, MACE, and MAKE.

Prognosis of IgA Nephropathy with Stages 3b-5 CKD

Introduction: There are conflicting opinions regarding the use of immunosuppressant treatment in IgA nephropathy (IgAN) patients with an estimated glomerular filtration rate (eGFR) of less than 45 mL/min/1.73 m2 and persistent proteinuria with a daily excretion of ≥1.0 g. Methods: This retrospective study involved 110 IgAN patients for whom clinical data were available; of these, 90 had complete follow-up data. Patients were grouped based on whether they received immunotherapy during follow-up, their renal function, proteinuria levels, and the percentage of crescentic glomeruli observed at the time of renal biopsy. Results: The mean eGFR for the participants was 32.0 ± 10.2 mL/min/1.73 m2. The average follow-up duration was 46.1 ± 37.9 months. The mean rate of decline in eGFR was 3.6 mL/min/1.73 m2 per year. There were 43 (47.8%) composite kidney endpoints occurred in these patients. In the group that received immunotherapy, the incidence of kidney endpoint events was lower than in the untreated group (45.1% vs. 57.9%), but the difference was not statistically significant (p = 0.320). Among patients with stage CKD 3b, the incidence of endpoint events was lower than in those with stages CKD 4 and 5 (36.8% vs. 66.7%, p = 0.006). Conversely, the high proteinuria group saw a higher incidence of endpoint events compared to the low proteinuria group (51.9% vs. 23.1%), although this difference was not statistically significant (p = 0.054). Meanwhile, there was no significant difference in the incidence of endpoint events between the two crescent glomerular ratio groups (48.7% vs. 41.7%, p = 0.649). Kaplan-Meier survival analysis indicated that renal function level (p < 0.001) and proteinuria (p = 0.023) were associated with renal survival in IgAN patients. In contrast, the administration of immunosuppressive therapy (p = 0.288) and the prevalence of C lesions (p = 0.982) did not show a significant association with renal survival. Further, Cox regression analysis identified systolic blood pressure, fibrinogen, and CKD stage as risk factors for eGFR decline in IgAN patients (all p < 0.05). Conclusion: IgAN patients with stages 3b-5 CKD exhibited a poor prognosis. It appears that in this specific cohort of IgAN patients, immunosuppressive therapy may not provide significant advantages over supportive care therapeutic regimens in terms of disease management.

Impact of chronic kidney disease and end-stage renal disease on outcomes after complex endovascular and open aortic aneurysm repair

ObjectiveChronic kidney disease (CKD) and end-stage renal disease are traditionally associated with worse outcomes after endovascular aortic repair (EVAR) and open aneurysm repair (OAR) of abdominal aortic aneurysms (AAAs). However, there needs to be more data on complex AAA repair involving the aorta's visceral segment. This study stratifies complex AAA repair outcomes by CKD severity and dialysis dependence. MethodsAll patients undergoing elective OAR and fenestrated/branched EVAR (F-BEVAR) for complex AAA with preoperative renal function data captured by the Vascular Quality Initiative between January 2003 and September 2020 were analyzed. Patients were stratified by CKD class as follows: normal/mild (CKD 1 and 2), moderate (CKD class 3a), moderate to severe (CKD 3b), severe (CKD class 4 and 5), and dialysis. Only patients with clamp sites above one of the renal arteries were included for complex OAR. For F-BEVAR, patients with proximal landing zones below zone 5 (above celiac artery) were included, and distal landing zones between zones 1 and 5 were excluded. Primary outcomes were perioperative and 1-year mortality. Predictors of mortality were identified by Cox multivariate regression models. ResultsWe identified 7849 elective complex AAA repairs: 4230 (54%) complex OARs and 3619 (46%) F-BEVARs. Most patients were White (89%) and male (74%), with an average age of 72 ± 8 years. The patients who underwent F-BEVAR were older and had more comorbidities. Elective F-BEVAR for complex AAA started in 2012 and increased from 1.4% in 2012 to 58% in 2020 (P < .001). The OAR cohort had more perioperative complications, but less 1-year mortality. The normal/mild CKD cohort had the highest 1-year survival compared with other groups after both complex OAR and F-BEVAR. On Cox regression analysis, when compared with CKD 1-2, worsening CKD stage (CKD 3b: hazard ratio [HR], 2.5; 95% confidence interval [CI], 1.82-3.40; P < .001; CKD 4-5: HR, 1.9; 95% CI, 1.16-3.26; P = .011; and dialysis: HR, 4.4; 95% CI, 2.53-7.72; P < .001) were independently associated with 1-year survival after F-BEVAR. After complex OAR, worsening CKD stage but not dialysis was associated with 1-year mortality compared with CKD 1-2 (CKD 3b: HR, 1.6; 95% CI, 1.13-2.35; P = .009; CKD 4-5: HR, 3.4; 95% CI, 2.03-5.79; P < .001). ConclusionsCKD severity is an essential predictor of perioperative and 1-year mortality after complex AAA repair, irrespective of the treatment modality, which may reflect the natural history of CKD. Consideration should be given to raising the threshold for elective AAA repair in patients with moderate to severe CKD and end-stage renal disease, given the high 1-year mortality rate.

Abstract 14918: Apical Cardiomyopathy in a Transplanted Heart

Case description: A 67 year old female presented for annual review to the transplant clinic 4 years post orthotopic heart transplant for nonischemic dilated cardiomyopathy. She was asymptomatic. Her medical history included hypothyroidism, hypertension, osteoporosis, restless leg syndrome and calcineurin inhibitor related complications - CKD 3b, impaired glucose tolerance and a left partial glossectomy with neck dissection for stage 3 SCC of the left lateral tongue. Medications included aspirin, atorvastatin, prednisolone, tacrolimus, septrin and ropinirole. Family history was significant for heart failure in her father. She was a nonsmoker and did not consume alcohol. Physical examination was unremarkable. Diagnostic tests are shown below. Discussion: Apical hypertrophic cardiomyopathy (ApHCM) has rarely been described in post cardiac transplant populations. Characterized by increased left ventricular apical wall thickness, it results in a ‘spade-like’ appearance on imaging and is associated with marked T wave inversion on ECG. ApHCM is associated with progression to heart failure, apical aneurysm, ventricular arrhythmias and increased mortality rates. Patients may be asymptomatic at diagnosis. Regarding screening, criteria exist for the selection of donor hearts pre transplant with caution exercised if LVH &gt;13mm. Causes of non HCM hypertrophy in this population include calcineurin inhibitors, hypertension, obesity and graft versus host disease. Data for treatment for ApHCM is lacking however it follows the path of classical HCM, involving the use of beta and calcium channel blockers to reduce demand ischemia and management of sequelae.

PD32-07 RACE MODIFIED ESTIMATED GLOMERULAR FILTRATION RATE UNDERESTIMATES CHRONIC KIDNEY DISEASE PREVALENCE IN AFRICAN-AMERICAN PATIENTS UNDERGOING PARTIAL AND RADICAL NEPHRECTOMY: IMPLICATIONS FOR SURGICAL PLANNING

You have accessJournal of UrologyCME1 Apr 2023PD32-07 RACE MODIFIED ESTIMATED GLOMERULAR FILTRATION RATE UNDERESTIMATES CHRONIC KIDNEY DISEASE PREVALENCE IN AFRICAN-AMERICAN PATIENTS UNDERGOING PARTIAL AND RADICAL NEPHRECTOMY: IMPLICATIONS FOR SURGICAL PLANNING Hunter Hasley, Teona Iarajuli, Jennifer Nguyen, Daniel Thiemann, Martin Malik, Jaqui Roth, Michael Stifelman, Ravi Munver, Mutahar Ahmed, and Nitin Yerram Hunter HasleyHunter Hasley More articles by this author , Teona IarajuliTeona Iarajuli More articles by this author , Jennifer NguyenJennifer Nguyen More articles by this author , Daniel ThiemannDaniel Thiemann More articles by this author , Martin MalikMartin Malik More articles by this author , Jaqui RothJaqui Roth More articles by this author , Michael StifelmanMichael Stifelman More articles by this author , Ravi MunverRavi Munver More articles by this author , Mutahar AhmedMutahar Ahmed More articles by this author , and Nitin YerramNitin Yerram More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003325.07AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: In estimated glomerular filtration rate equations (eGFR), the race multiplier (RM) yields greater eGFR values and may assign less severe CKD stages to African-Americans (AA). When deciding on appropriateness for partial nephrectomy (PN) patients with CKD are often considered a relative or absolute indication for PN. We hypothesize that the eGFR RM may have potential ramifications for patients being counseled for radical (RN) vs. PN to manage their renal tumor. METHODS: We utilized prospective and retrospective, IRB-approved single-center databases to select AA patients who underwent PN or RN between 2016 and 2022. Demographics, preoperative risk factors, preoperative eGFR with and without the RM and surgical management were collected. Descriptive statistics and two-tailed difference of proportion tests were used to compare the percentage of patients with CKD who underwent RN. RESULTS: Out of 1139 patients who underwent RN or PN, 75 (6.6%) patients were AA. The RM vs. no RM mean±SD preoperative eGFR was 76.3±26.1 vs. 62.9±21.5; incidence of CKD 3a were 22.7% vs. 38.7% (p=0.034); incidence of CKD 3b were 8.0% vs. 16.0% (p=0.13), respectively. Table 1 summarizes the eGFR and incidence of CKD in AA with and without the RM compared to non-AA undergoing radical nephrectomy. We noted in all AA patients, regardless of using the RM, that the incidence of CKD3a and CKD 3b was significantly higher compared to non-AA undergoing RN. This difference was accentuated when removing the RM. CONCLUSIONS: We noted a statistically higher incidence of CKD in AA patients undergoing RN compared with non-AA patients. This difference was accentuated when removing the RM. Limitations include selection bias and small cohort of AA. These findings have potential ramifications for surgical planning of PN vs RN based on presence of CKD and may contribute to healthcare inequalities. Source of Funding: None © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e909 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Hunter Hasley More articles by this author Teona Iarajuli More articles by this author Jennifer Nguyen More articles by this author Daniel Thiemann More articles by this author Martin Malik More articles by this author Jaqui Roth More articles by this author Michael Stifelman More articles by this author Ravi Munver More articles by this author Mutahar Ahmed More articles by this author Nitin Yerram More articles by this author Expand All Advertisement PDF downloadLoading ...

Chronic kidney disease impacts outcomes after abdominal aortic aneurysm repair

ObjectiveChronic kidney disease (CKD) and end-stage renal disease are traditionally associated with worse outcomes after endovascular and open repair of abdominal aortic aneurysm (AAA). This study stratifies outcomes of AAA repair by approach, CKD severity, and dialysis dependence. MethodsAll patients undergoing elective infrarenal open aneurysm repair (OAR) and endovascular aortic repair (EVAR) with preoperative renal function data captured by the Vascular Quality Initiative between January 2003 and September 2020 were analyzed. Patients were stratified by CKD class as follows: CKD stages 1 and 2, CKD stage 3a, CKD stage 3b, CKD stages 4 and 5, and dialysis. Primary outcomes were perioperative and 1-year mortality. Predictors of survival were identified by Cox multivariate regression models. ResultsIn total, 53,867 elective AAA repairs were identified: 5396 (10%) OARs and 48,471 (90%) EVARs. Most patients were White (90%) and male (81%), with a mean age of 73 ± 9 years. Patients who underwent EVAR were older and had more comorbidities. The use of elective EVAR for AAA increased from 52% in 2003 to 91% in 2020 (P < .001). The OAR cohort had more perioperative complications and short-term mortality. The CKD 1 and 2 group had the highest 1-year survival compared with the other groups after both OAR and EVAR. On Cox regression analysis, after EVAR, compared with CKD 1 and 2, worsening CKD stage (CKD 3a: hazard ratio [HR], 1.25; 95% confidence interval [CI], 0.93-1.68; P = .13; CKD 3b: HR, 1.74; 95% CI, 1.23-2.45; P < .050; CKD 4-5: HR, 3.23; 95% CI, 2.13-4.88; P < .001), and dialysis (HR, 4.48; 95% CI, 1.90-10.6; P < .001) were independently associated with worse 1-year survival rates. After OAR, compared with CKD 1 and 2, worsening CKD stage (CKD 3a: HR, 1.08; 95% CI, 0.96-1.20; P = .20; CKD 3b: HR, 1.60; 95% CI, 1.41-1.81; P < .001; CKD 4-5: HR, 2.85; 95% CI, 2.39-3.41; P < .001), and dialysis (HR, 3.79; 95% CI, 3.01-4.76; P < .001) were independently associated with worse 1-year survival rates. ConclusionsRegardless of the treatment approach, CKD severity is an important predictor of perioperative and 1-year mortality rates after infrarenal AAA repair and may reflect the natural history of CKD. Open repair is associated with high perioperative mortality risk in patients with CKD stages 4 and 5, as well as end-stage renal disease. Individualization of patient decision-making is especially important in patients with a glomerular filtration rate of less than 45 and perhaps consideration should be given to raising the threshold for elective AAA repair in these patients. Further studies focusing on appropriate size threshold for repair in these patients may be warranted.

963-P: Preservation of Renal Function in Patients with Diabetes and Comorbid CKD 3 as Measured by eGFR in 1,877 Elderly Patients at CanoHealth. A Two-Year Retrospective EHR-Based Analysis.

This study sought to explore the effect of the CANO Model of Care (CMC) on renal function in elderly Medicare Advantage patients. A 2-Y retrospective review of laboratory data for patients new to CANO (≤3 mos) between Jan 1 and Dec 31, 2018 with diabetes and CKD 3 was conducted. We identified 1,877 patients and collected eGFR, A1C, BMI, SBP/DBP at baseline and at various time points for 24 months (Table 1) . Mean age was 76.5 +/- 9.2Y. Preservation of renal function as represented by eGFR was evident at all time points. Statistically significant improvements in eGFR values were observed during the first 15 months, with no significant changes from baseline for months 18 to 24. Renal function in patients with diabetes and CKD 3 decreases over time. In this cohort renal function, as measured by eGFR, was preserved for 24 months. Subgroup analysis of patients with CKD 3b (n=606) shows similar results. The preservation in renal function may be attributable in part to the Cano Model of Care. The CMC includes a propriety population health platform (CanoPanorama™) which informs care management decisions, imbedded structured data within the EHR, attainment of high PCP NCQA recognition for diabetes care (1) , monthly coordinated physician CMEs, pursuit of 5-star HEDIS® (2) quality metric ratings, and addressing clinical inertia (3) . Disclosure R.Aguilar: Speaker's Bureau; Boehringer Ingelheim International GmbH, Lilly Diabetes, Novo Nordisk A/S. R.E.Kenney: None. E.Antunez: None. M.Osorio: None. M.Herman: None. M.Conger: None. M.Aguilar: None.

On-clamp versus purely off-clamp robot-assisted partial nephrectomy in solitary kidneys: comparison of perioperative outcomes and chronic kidney disease progression at two high-volume centers.

Minimal literature describes the impact of hilar control on the progression to chronic kidney disease (pCKD) after robotic partial nephrectomy (RPN) in solitary kidneys (SK). The aim of this study was to compare purely off-clamp (ocRPN) vs. on-clamp robotic partial nephrectomy (onRPN) in SK and to identify predictors of pCKD at two high-volume centers. Between December 2013 and October 2019, 54 patients with SK underwent ocRPN and onRPN for renal tumors at two institutions. Baseline and perioperative data were analyzed. Newly onset of CKD stage 3b,4,5 (CKD3b,4,5) was assessed by Kaplan-Meier curves and compared for warm ischemia time (WIT) with the log-rank test. Cox regression analysis was used to identify predictors of pCKD. At a median follow-up of 13 months (IQR 6.3-34), newly onset of CKD3b and CKD 4.5 were observed in 11.1% and 7.4% of patients, respectively. onRPN was associated with a higher risk of progression to CKD 3b,4,5 stages (P=0.034) and higher rate of perioperative complications (P=0.03). On univariable analysis eGFR at discharge (eGFRd), positive surgical margins status (PSM) and WIT were predictors of newly onset of CKD3b,4,5 (each P<0.05). Multivariable analysis identified eGFRd (HR 0.88; CI 95% 0.81-0.96) and WIT (HR 1.09; CI 95% 1.02-1.16) as independent predictors of pCKD (each P<0.01). Main limitations include the retrospective nature of the study, the short-term follow-up and the lack of data adjustment for parenchymal volume loss. eGFRd and WIT during RPN are independent predictors of pCKD in SK. In this setting a critical reduction of WIT should be achieved according to the oncologic outcome. In patients with SK, WIT represents the only surgical modifiable factor of RPN for avoiding a quicker onset of pCKD.

Can Renal Parameters Predict the Mortality of Hospitalized COVID-19 Patients?

Introduction: Our study aimed to analyze whether renal parameters can predict mortality from COVID-19 disease in hospitalized patients. Methods: This retrospective cohort includes all adult patients with confirmed COVID-19 disease who were consecutively admitted to the tertiary hospital during the 4-month period (September 1 to December 31, 2020). We analyzed their basic laboratory values, urinalysis, comorbidities, length of hospitalization, and survival. The RIFLE and KDIGO criteria were used for AKI and CKD grading, respectively. To display renal function evolution and the severity of renal damage, we subdivided patients further into 6 groups as follows: group 1 (normal renal function), group 2 (CKD grades 2 + 3a), group 3 (AKI-DROP defined as whose s-Cr level dropped by >33.3% during the hospitalization), group 4 (CKD 3b), group 5 (CKD 4 + 5), and group 6 (AKI-RISE defined as whose s-Cr level was elevated by ≥50% within 7 days or by ≥26.5 μmol/L within 48 h during hospitalization). Then, we used eGFR on admission independently of renal damage to check whether it can predict mortality. Only 4 groups were used: group I – normal renal function (eGFR > 1.5 mL/s), group II – mild renal involvement (eGFR 0.75–1.5), group III – moderate (eGFR 0.5–0.75), and group IV – severe (GFR <0.5). Results: A total of 680 patients were included in our cohort; among them, 244 patients displayed normal renal function, 207 patients fulfilled AKI, and 229 patients suffered from CKD. In total, a significantly higher mortality rate was found in the AKI and the CKD groups versus normal renal function – 37.2% and 32.3% versus 9.4%, respectively (p < 0.001). In addition, the groups 1–6 divided by severity of renal damage reported mortality of 9.4%, 21.2%, 24.1%, 48.7%, 62.8%, and 55.1%, respectively (p < 0.001). The mean hospitalization duration of alive patients with normal renal findings was 9.5 days, while it was 12.1 days in patients with any renal damage (p < 0.001). When all patients were compared according to eGFR on admission, the mortality was as follows: group I (normal) 9.8%, group II (mild) 22.1%, group III (moderate) 40.9%, and group IV (severe) 50.5%, respectively (p < 0.001). It was a significantly better mortality predictor than CRP on admission (AUC 0.7053 vs. 0.6053). Conclusions: Mortality in patients with abnormal renal function was 3 times higher compared to patients with normal renal function. Also, patients with renal damage had a worse and longer hospitalization course. Lastly, eGFR on admission, independently of renal damage type, was an excellent tool for predicting mortality. Further, the change in s-Cr levels during hospitalization reflected the mortality prognosis.

Comparison of renal function after open radical cystectomy, extracorporeal robot assisted radical cystectomy, and intracorporeal robot assisted radical cystectomy

PurposeRenal function outcomes following robot-assisted radical cystectomy (RARC) have not been well established. We sought to compare long-term renal function outcomes between open radical cystectomy, RARC with extracorporeal urinary diversion and intracorporeal urinary diversion at a high volume institution. Materials and MethodsWe retrospectively reviewed our institutional bladder cancer database for patients who underwent RC from 2010 to 2019 with pre-operative estimated glomerular filtration rate (eGFR) > 45 ml/min/1.73m2. Changes in renal function were assessed through locally weighted scatter plot smoothing and comparison of median eGFR between surgical groups. Chronic Kidney Disease Stage 3B was defined as eGFR < 45 ml/min/1.73m2. Renal function decline was defined as a ≥10 ml/min/1.73m2 drop in eGFR. Kaplan Meier method with log-rank was used to compare CKD 3B-free survival and renal function decline. Cox Proportional Hazards model was used to identify predictors of CKD 3B. ResultsSix hundred and forty four patients were included with median follow-up of 32 months (IQR 12–56). Preoperative characteristics were similar among the groups with no differences in median pre-operative eGFR (ORC: 74.6, extracorporeal urinary diversion: 74.3, intracorporeal urinary diversion: 71.6 ml/min/1.73m2, P=0.15). Median postoperative eGFR on follow up was not different between groups (P=0.56). 33% of patients developed CKD 3B. There were no differences in CKD 3B-free survival by surgical approach (P = 0.23) or urinary diversion (P = 0.09). 64% of patients experienced renal function decline with a median time of 2.4 years (P 0.23). Predictors of CKD were pathologic T3 disease or greater (HR: 1.77, P = 0.01), ureteroenteric anastomotic stricture (HR: 2.80, P < 0.001), preoperative CKD Stage 2 (HR: 1.81, P =0.02), and preoperative CKD Stage 3A (HR: 5.56, P < 0.001). ConclusionRenal function decline is common after RC. Tumor stage, pre-operative eGFR, and ureteral stricture development, not surgical approach, influence renal function decline.

P1372PRE-DIALYSIS HAEMOGLOBIN TARGET ATTAINMENT AND POST-DIALYSIS OUTCOMES IN PERSONS WITH RENAL ANAEMIA: A NATIONWIDE STUDY

Abstract Background and Aims Attaining the narrow hemoglobin range (10-12 g/dL) recommended by current ERBP renal anemia guidelines may be difficult, and whether this leads to better outcomes is not well known. This study aimed to identify patient and clinical factors associated with difficulties in maintaining hemoglobin target ranges in routine non-dialysis nephrologist care. We also evaluated whether adherence to ERBP hemoglobin recommendations during pre-dialysis care predicted early post-dialysis outcomes. Method Observational study from the Swedish Renal Registry including all patients with non-dialysis dependent CKD stages 3b-5 developing renal anemia or initiating treatment (iron, ESA or both) between 2012-2016. Through multinomial logistic regression with clustered variance, we identified clinical conditions associated to serum hemoglobin values outside the ERBP recommended range (&amp;lt;10 and &amp;gt;12 g/dL) throughout all recorded patient visits until death, dialysis or end of follow-up. For those who initiated dialysis, we calculated the proportion of patient-time in which hemoglobin was maintained within range (time in range [TIR]). We then explored associations between TIR and subsequent one-year risk of death or MACE (composite of death caused by CVD and non-fatal MI, stroke, heart failure) with Cox proportional hazards regression. Results A total 8106 patients with CKD 3b-5 developed incident anemia in Sweden during 2012-2016, contributing with 37422 nephrology visits during median 2 years of follow up. In multinomial logistic regression, being a man and having received iron or higher ESA doses was associated with hemoglobin values outside target range. Patients with CKD 3b and 4, ongoing transplant, history of CVD, or with higher serum calcium and albumin levels had higher odds of maintaining hemoglobin values above range. Conversely, recent bleeding or transfusions, nephrosclerosis, inflammation (CRP&amp;gt;5 mg/dl), and higher phosphate levels increased the odds of having hemoglobin values below range. A total 2435 patients initiated maintenance dialysis during the study period. Of those, 327 died and 701 developed MACE during the subsequent year. Their median TIR during their pre-dialysis period was 44% (IQR: 34-50). On a continuous scale (FIGURE), we observed worse outcomes for patients with poor guideline recommendation adherence (low percentage TIR), although the association was judged weak. On a categorical scale, patients that spent more than 40% of their pre-dialysis TIR had lower hazards of death (0.57, 95% CI 0.41-0.80) and MACE (0.67, 95% CI, 0.54-0.84) compared to those with &amp;lt;44% TIR. Conclusion This nationwide study reports that greater adherence to ERBP anemia guidelines during pre-dialysis care, using existing conventional therapeutic approaches, is associated with better post-dialysis outcomes. Whether active interaction by healthcare practitioners affected the observed relationship needs to be further explored.

P1254CARDIAC TISSUE CHARACTERISATION AND AUTONOMIC FUNCTION IN PATIENTS WITH CHRONIC KIDNEY DISEASE AND ON HAEMODIALYSIS: A PILOT STUDY

Abstract Background and Aims Sudden cardiac death rates are higher in patients with CKD and on haemodialysis. Hypotheses include the presence of diffuse myocardial fibrosis secondary to fluid and toxin overload. Native T1, T2 and T2* mapping through cardiac magnetic resonance (CMR) is emerging as a novel technique to quantify myocardial fibrosis. This pilot study aimed to quantify cardiac morphological change using CMR native T1, T2 and T2* mapping and correlate with autonomic provocation testing, in CKD 3b-5 and haemodialysis patients. Method Patients with stable CKD 3b and higher, and patients on haemodialysis (CKD-haemodilaysis) underwent a non-contrast CMR, which included native T1, T2, T2* mapping. Autonomic provocation testing was performed using a dipolar ECG lead, followed by 14-days of recording. Results were compared between patient groups, and T1, T2, T2* maps compared to healthy controls using the student t test and Kruskal-Wallis tests. Results Nine CKD, eight haemodialysis and seven control patients were recruited (Table 1). Of the late-stage CKD patients, three were stage 3b, four were stage 4 and two were stage 5. There were no significant differences between the two patient groups in baseline characteristics (Table 1). There were no significant differences between CKD and CKD-haemodialysis patients in left ventricular end-diastolic volume index, left ventricular end-systolic volume index, right ventricular end-diastolic volume index, right ventricular end-systolic volume index, ejection fraction, and left ventricular mass index (71.1±15.2 vs. 80.51 ±21.9 ml/m2, p=0.316; 24.4±7.09 vs. 34.4±19.4 ml/m2, p=0.171; 67.11 ± 14.9 vs. 75.5±23.4 ml/m2, p=0.386; 22.2±4.87 vs. 23.9±9.93 ml/m2, p=0.663; 65.8±6.34 vs. 59.5±12.4 %, p=0.200; 48.4±8.60 vs. 50.5±11.0 g/m2, p=0.673). T1 and T2 were significantly increased in CKD and CKD-haemodialysis patients compared to healthy controls (1259±57.7 vs. 1204±22.3 ms, p=0.038 and 49.1±4.74 vs. 42.0±2.79 ms, p=0.034). There was no difference in T2* star (32.8±7.59 vs. 28.8±3.77, p=0.291). There was no significant difference in native T1, T2 and T2* times between CKD and CKD-haemodialysis patients (1247±66.7 vs. 1273±45.7, p=0.361; 49.1±5.22 vs. 49.0±4.49, p=0.960; 34.1±7.57 vs. 31.3±7.81, p=0.769). Mean percentage change of HR in CKD patients from lying to sitting to standing was 4.51%±6.66 and 11.5%±11.8 respectively. Mean percentage change of HR in CKD-haemodialysis from lying to sitting to standing was 2.15%±6.30 and 6.0%±4.45 respectively. There were no significant differences in postural HR variability between CKD and CKD-haemodialysis patients (p=0.478 and p=0.237). Conclusion In late stage CKD, cardiac volumes, mass, ejection fraction and native T1, T2 and T2* are comparable to those of patients on long-term haemodialysis. However native T1 and T2 times are significantly elevated in later stage CKD and haemodialysis, compared to healthy controls. Heart rate changes over postural provocation are comparable between CKD and CKD-haemodialysis patients, although autonomic response is reduced compared to previously published data in healthy controls. Processes that drive myocardial fibrosis may start earlier in CKD pathogenesis.

136-LB: Efficacy and Safety of Sotagliflozin (SOTA) in Patients with Type 2 Diabetes (T2D) and Moderate Renal Impairment

SOTA is a sodium-glucose linked cotransporter (SGLT)-1 in the GI tract and SGLT2 in the kidney. Compared to selective SGLT2 inhibitors, SOTA has the potential to retain glycemic-lowering efficacy in patients with renal insufficiency. In a 52-week, Phase 3 study, SOTA 200 and 400 mg QD, were evaluated in adults with T2D (HbA1C 7-11%) and Stage 3 CKD (eGFR ≥30-60 mL/min/1.73m2) to demonstrate statistical superiority vs. placebo (PBO) in reducing HbA1C at Week 26. Prespecified sequential testing of HbA1C reduction with SOTA 400 mg vs. PBO in the full CKD population was followed by Stage 3A and Stage 3B cohorts before testing SOTA 200 mg. ANCOVA models with retrieved dropouts and/or washout imputation methods were used for primary and prespecified secondary endpoints. In the full population (N=787), the least squares mean (LSM) difference between SOTA 400 mg and PBO for the change in HbA1C at Week 26 was −0.23% (p=0.002). In the CKD 3A (n=394) and CKD 3B cohorts (n=393), LSM differences for SOTA 400 mg vs. PBO were −0.31% (p=0.004) and −0.15% (p=0.158); respectively. SOTA 200 mg did not significantly reduce HbA1C in any cohort vs. PBO. In an exploratory analyses, PBO-corrected reductions in the urinary albumin-to-creatinine ratio were −38% (p&amp;lt;0.001) with SOTA 400 mg and −31% (p=0.001) with SOTA 200 mg. The expected “dip” in eGFR (3-4 mL/min/1.73 m2) with SOTA initiation was observed and trended back towards baseline. The rate of adverse events through 52 weeks was generally low. In the SOTA 400 mg, SOTA 200 mg, and PBO groups, genital mycotic infections (1.9%, 1.5%, and 0.8%), volume depletion (3.8%, 3.4%, and 1.5%), and diarrhea (8.5%, 6.7%, and 4.2%) were reported. Hypoglycemia ≤54 mg/dL was lower with SOTA 400 mg (5.4%) vs. PBO (10.8%). To conclude, statistically and clinically significant metabolic and renal effects of SOTA 400 mg were observed at 26 weeks in patients with T2D and Stage 3CKD. Long-term effects are being assessed in clinical outcomes trials. Disclosure D. Cherney: Research Support; Self; Boehringer Ingelheim-Lilly, Merck, Janssen, Sanofi, AstraZeneca and Novo-Nordisk. Other Relationship; Self; from Boehringer Ingelheim-Lilly, Merck, AstraZeneca, Sanofi, Mitsubishi-Tanabe, Abbvie, Janssen, Bayer, Prometic, BMS and Novo-Nordisk. E. Ferrannini: Consultant; Self; Boehringer Ingelheim International GmbH, Eli Lilly and Company, Oramed Pharmaceuticals. Research Support; Self; AstraZeneca, Janssen Pharmaceuticals, Inc. G.E. Umpierrez: None. A.L. Peters: Advisory Panel; Self; Abbott, Bigfoot Biomedical, Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, MannKind Corporation, Medscape, Novo Nordisk Inc., Sanofi US. Consultant; Self; Livongo Health. Research Support; Self; Dexcom, Inc., vTv Therapeutics. Other Relationship; Self; Livongo Health, Mellitus Health, Omada Health, Stability Healthcare, Whole Biome Inc. J. Rosenstock: Research Support; Self; AstraZeneca, Bristol-Myers Squibb, Genentech, Inc., GlaxoSmithKline plc., Lexicon Pharmaceuticals, Inc., Oramed Pharmaceuticals, PegBio Co., Ltd., Pfizer Inc., REMD Biotherapeutics. Other Relationship; Self; Applied Therapeutics, Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, Intarcia Therapeutics, Janssen Pharmaceuticals, Inc., Novo Nordisk Inc., Sanofi. A.K. Carroll: Employee; Self; Lexicon Pharmaceuticals, Inc. Stock/Shareholder; Self; Lexicon Pharmaceuticals, Inc. S. Sawhney: None. P.L. Banks: Employee; Self; Lexicon Pharmaceuticals, Inc. W. Jiang: Employee; Self; Lexicon Pharmaceuticals, Inc. Stock/Shareholder; Self; Lexicon Pharmaceuticals, Inc. P. Lapuerta: Employee; Self; Lexicon Pharmaceuticals, Inc. Stock/Shareholder; Self; Lexicon Pharmaceuticals, Inc.

End Points for Clinical Trials in Primary Hyperoxaluria.

Patients with primary hyperoxaluria experience kidney stones from a young age and can develop progressive oxalate nephropathy. Progression to kidney failure often develops over a number of years, and is associated with systemic oxalosis, intensive dialysis, and often combined kidney and liver transplantation. There are no therapies approved by the Food and Drug Association. Thus, the Kidney Health Initiative, in partnership with the Oxalosis and Hyperoxaluria Foundation, initiated a project to identify end points for clinical trials. A workgroup of physicians, scientists, patients with primary hyperoxaluria, industry, and United States regulators critically examined the published literature for clinical outcomes and potential surrogate end points that could be used to evaluate new treatments. Kidney stones, change in eGFR, urine oxalate, and plasma oxalate were the strongest candidate end points. Kidney stones affect how patients with primary hyperoxaluria feel and function, but standards for measurement and monitoring are lacking. Primary hyperoxaluria registry data suggest that eGFR decline in most patients is gradual, but can be unpredictable. Epidemiologic data show a strong relationship between urine oxalate and long-term kidney function loss. Urine oxalate is reasonably likely to predict clinical benefit, due to its causal role in stone formation and kidney damage in CKD stages 1-3a, and plasma oxalate is likely associated with risk of systemic oxalosis in CKD 3b-5. Change in slope of eGFR could be considered the equivalent of a clinically meaningful end point in support of traditional approval. A substantial change in urine oxalate as a surrogate end point could support traditional approval in patients with primary hyperoxaluria type 1 and CKD stages 1-3a. A substantial change in markedly elevated plasma oxalate could support accelerated approval in patients with primary hyperoxaluria and CKD stages 3b-5. Primary hyperoxaluria type 1 accounts for the preponderance of available data, thus heavily influences the conclusions. Addressing gaps in data will further facilitate testing of promising new treatments, accelerating improved outcomes for patients with primary hyperoxaluria.

Early Renal Recovery after Left Ventricular Assist Device Implantation is Associated with Improved Clinical Outcomes in Patients with Kidney Disease at Baseline

Purpose Advanced renal dysfunction is often viewed as a relative contraindication to durable left ventricular assist device (LVAD) implantation. We investigated the impact of early renal recovery on clinical outcomes after LVAD implantation. Methods All patients with baseline renal dysfunction who were implanted with a durable LVAD between September 2007 and September 2017 from a single institution were studied. Glomerular filtration rates at time of LVAD implant, 1 week, 1 month and 6 months after implant were collected. Early renal improvement was defined as an increase in eGFR of ≥ 15% within 1 week of implant (ΔGFR≥15%). Outcomes collected included index hospitalization length of stay (LOS), LVAD-related complications, hospitalizations and death. Results 405 patients were implanted with durable LVADs, of which, 191 patients (average age 59 years, 80% male, 73% African American, 46% bridge to transplant, 59% centrifugal) had varying degrees of renal dysfunction at implantation (17% CKD 1 or 2, 35% CKD 3a, 33% CKD 3b and 15% CKD 4 or 5). 68% of patients experienced ΔGFR≥15%. African American ethnicity and obesity (BMI 31.6 ± 6.9 vs. 28.7 ± 6.9, p =0.01) was associated with less renal improvement compared with their counterparts. Patients with ΔGFR≥15% were more likely to be CKD stage 1 or 2 six months after LVAD implant (53% vs. 22%, p = 0.005) (figure top). Index hospitalization LOS (39 ± 21 vs. 50 ± 32 days, p =0.02) was lower in patients with ΔGFR≥15% with fewer percutaneous endoscopic gastrostomy tube placement (4% vs. 15%, p = 0.02) and tracheostomy (6% vs 13%, p = 0.14). Patients with ΔGFR≥15% also had fewer heart failure readmissions (12% vs. 24%, p Conclusion Early improvement in renal function is associated with sustained renal recovery, decreased length of stay, fewer complications at index hospitalization and reduced heart failure readmissions.

Case Report Ramsay Hunt Syndrome presenting as “a window’’ to HIV diagnosis in 48 year old African female: A case report

Background: Ramsay Hunt Syndrome in adults is reported in a number of case reports as an uncommon presentation of Varicella zoster Virus infection. Ramsay Hunt Syndrome occurs when there is reactivation of the latent Varicella zoster virus present in the ganglia due to previous varicella infection. Following a breakdown of the immune system, latent Varicella zoster infection can be activated. HIV (Human Immunodeficiency Virus infection), causes immunosuppression and hence reactivation of Varicella zoster. The diagnosis of Ramsay Hunt Syndrome, gives a window of opportunity to investigate for HIV. Here we report our first case of Ramsay Hunt syndrome as a presenting feature of HIV disease in an apparently healthy looking 48 year old black African female who was unaware of her HIV status at the time of presentation.&#x0D; This case is reported in order to highlight the need to use Ramsay Hunt Syndrome as a window of opportunity to screen for underlying HIV.&#x0D; Case presentation: A 48 year old black African female who was unaware of her HIV status, presented to our outpatients department with a two day history of painful right ear pain, vesicles on the right pinna and inability to completely close her right eye, her mouth was deviated to the left, with a wrinkle free frown. She denied any alteration in taste sensation and hyperacusis. She had a grade IV House-Brackmann facial paralysis.A diagnosis of Ramsay Hunt Syndrome was made and an HIV test was offered, the test was positive for HIV.A subsequent HAART (Highly Active Antiretroviral Therapy) work up, revealed CKD 3B (Chronic Kidney Disease stage 3B) and a CD4 (cluster of differentiation 4) count of 217 cells/µl .She was started on antiretroviral therapy 2 weeks after completing a 10 day regimen of acyclovir. In addition to her drug treatment she received ocular care and physiotherapy. Four months on her facial nerve function has improved modestly.&#x0D; Conclusion: An HIV test should be an indispensable part of the Ramsay Hunt syndrome workup, as its diagnosis gives a window of opportunity to diagnose HIV and offer life- saving HAART.

Ramsay Hunt syndrome presenting as “a window'' to HIV diagnosis in 48 year old African female: A case report

Background: Ramsay Hunt syndrome in adults is reported in a number of case reports as an uncommon presentation of Varicella - zoster Virus infection. Ramsay Hunt syndrome occurs when there is reactivation of the latent Varicella - zoster virus present in the ganglia due to previous varicella infection. Following a breakdown of the immune system, latent Varicella - zoster infection can be activated. Human Immunodeficiency Virus infection (HIV), causes immunosuppression and hence reactivation of Varicella - zoster. The diagnosis of Ramsay Hunt syndrome, gives a window of opportunity to investigate for HIV. Here we report our first case of Ramsay Hunt syndrome as a presenting feature of HIV disease in an apparently healthy looking 48 year old black African female who was unaware of her HIV status at the time of presentation.&#x0D; This case is reported in order to highlight the need to use Ramsay Hunt syndrome as a window of opportunity to screen for underlying HIV.&#x0D; Case presentation: A 48 year old black African female who was unaware of her HIV status, presented to our outpatients department with a two day history of painful right ear pain, vesicles on the right pinna and inability to completely close her right eye, her mouth was deviated to the left, with a wrinkle free frown. She denied any alteration in taste sensation and hyperacusis. She had a grade IV House-Brackmann facial paralysis. A diagnosis of Ramsay Hunt syndrome was made and an HIV test was offered, the test was positive for HIV. A subsequent Highly Active Antiretroviral Therapy (HAART) work up, revealed Chronic Kidney Disease stage 3B (CKD 3B) and a cluster of differentiation 4(CD4) count of 217 cells/μl .She was started on antiretroviral therapy 2 weeks after completing a 10 day regimen of acyclovir. In addition to her drug treatment she received ocular care and physiotherapy. Four months on her facial nerve function has improved modestly.&#x0D; Conclusion: An HIV test should be an indispensable part of the Ramsay Hunt syndrome workup, as its diagnosis gives a window of opportunity to diagnose HIV and offer life- saving HAART.

Использование балльных шкал, предложенных в Клинических рекомендациях European Renal Best Practice для оценки прогноза у пожилых и ослабленных пациентов на поздних стадиях ХБП

Использование балльных шкал, предложенных в Клинических рекомендациях European Renal Best Practice для оценки прогноза у пожилых и ослабленных пациентов на поздних стадиях ХБП

Patterns and Predictors of Screening for Breast and Cervical Cancer in Women with CKD.

Breast and cervical cancers are prevalent in women with CKD, but it is uncertain how often screening for these cancers should be undertaken given concerns that the benefits of screening may be fewer and the harms greater in women with CKD than in the general population. We examined patterns of breast and cervical cancer screening in women on the basis of CKD stage and age and assessed predictors of screening. We conducted two population-based cohort studies (breast and cervical cancer screening) from 2002 to 2013 using linked administrative health care data from Ontario, Canada. A total of 141,326 and 324,548 women were included in the breast and cervical cancer screening cohorts, respectively. The 2-year cumulative incidences were 61% among women without CKD, 54% for those with CKD stages 3a and 3b, 37% for those with CKD stages 4 and 5, and 26% for women on dialysis. Similar patterns were observed for the 3-year cumulative incidences of cervical cancer screening. The associations of breast and cervical cancer screening with CKD were modified by age and CKD stage, where lower incidence of screening in women with advanced CKD compared with no CKD was most pronounced in older age groups (P<0.001). Older age, higher comorbidity burden, and lower-income groups were associated with a lower rate of screening. Most women with advanced CKD do not receive breast or cervical cancer screening. A better understanding of patient and health professional preferences toward cancer screening in CKD is needed along with the outcomes of such screening.

Relationship between Estimated Glomerular Filtration Rate and Cardiovascular Mortality in a Japanese Cohort with Long-Term Follow-Up.

BackgroundPatients with renal impairment are at risk of not only end-stage kidney disease but also cardiovascular disease (CVD). The current definition of CKD stage G3a is eGFR 45–59 ml/min/1.73 m2 and of G3b is 30–44 ml/min/1.73 m2, and subjects in the CKD 3a category are considered to be at lower risk of mortality than are those in CKD 3b.MethodsWe evaluated the outcome of 97,043 people (33,131 men and 63,912 women) living in Ibaraki Prefecture who underwent annual community-based health checkups beginning in 1993 at age 40–80 years and who were followed for a mean of 17.1 years.ResultsThe number of all-causes deaths was 20,534 (10,375 men and 10,159 women), of which 5,995 (2,695 men and 3,300 women) were deaths due to CVD. Multivariable-adjusted hazard ratio for CVD death in the eGFR 45–49 ml/min/1.73 m2 category was significantly increased (1.82; 95% confidential interval, 1.23–2.69) in non-elderly men, whereas all-cause mortality and CVD mortality in elderly men with eGFR 45–49 ml/min/1.73m2 were non significant. In contrast, both in non-elderly women and in elderly women with eGFR 45–49 ml/min/1.73 m2 showed small, but significant, increases in the risks of all-cause mortality and CVD.ConclusionsWe demonstrated proportionate increases in mortality with decreasing eGFR in a Japanese CKD population. Like patients in the CKD G3b subgroup, non-elderly men and women with an eGFR of 45–49 ml/min/1.73 m2 (i.e. a part of CKD G3a) are at considerable risk of CVD mortality. Age dependent and eGFR dependent finer risk recognition were required for CVD prevention in clinical practice with regard to CKD patients.