Ketoanalogue-Supplemented Low-Protein Diet in Patients with Stage 4+ Chronic Kidney Disease in Italy: A Cost-Utility Analysis.
Background/Objectives: Chronic kidney disease (CKD) is associated with substantial clinical and economic burden, largely driven by progression to dialysis. Nutritional interventions have shown potential in delaying disease progression, yet evidence on their cost-effectiveness remains limited. This study evaluated the long-term cost-utility profile of a low-protein diet supplemented with ketoanalogues (s-LPD) versus a standard low-protein diet (LPD) in patients with stage 4+ CKD from both the Italian National Health System (NHS) and societal perspectives. Methods: A Markov model with monthly cycles simulated disease progression from pre-dialysis to dialysis or death. Clinical inputs were derived from the published literature, while costs reflected 2024 Italian tariffs. Three effectiveness scenarios (optimistic, conservative, and pessimistic) were explored to account for uncertainty in the treatment effect. Outcomes included costs, life-years, quality-adjusted life-years (QALYs), and incremental cost-utility ratios. Deterministic and probabilistic sensitivity analyses assessed model robustness. Results: Across all scenarios, s-LPD improved survival (up to +0.59 life-years), increased QALYs (up to +0.48), and delayed dialysis initiation (up to +2.88 years) compared with LPD. From the NHS perspective, s-LPD was dominant in the optimistic scenario and cost-effective in both conservative and pessimistic scenarios, with cost savings or only a marginal cost that increases under extreme assumptions. Probabilistic sensitivity analyses confirmed a high probability of cost-effectiveness across scenarios. Results remained robust in additional scenario analyses, including the societal perspective. Conclusions: This first Italian cost-utility analysis of s-LPD highlights that s-LPD is a cost-effective strategy for patients with advanced CKD, offering clinically meaningful benefits while reducing or containing healthcare costs. These findings support the adoption of s-LPD as part of conservative management strategies aimed at safely delaying dialysis initiation.
- Research Article
88
- 10.1038/ki.2012.420
- Apr 1, 2013
- Kidney International
The mean dietary protein intake at different stages of chronic kidney disease is higher than current guidelines
- Front Matter
7
- 10.1053/j.jrn.2022.05.001
- May 16, 2022
- Journal of Renal Nutrition
Unleashing the Power of Renal Nutrition in Value-Based Models of Kidney Care Choices: Leveraging Dietitians’ Expertise and Medical Nutrition Therapy to Delay Dialysis Initiation
- Research Article
10
- 10.1053/j.jrn.2022.09.004
- Sep 28, 2022
- Journal of Renal Nutrition
Economic Analysis of a Ketoanalogue-Supplemented Very Low-Protein Diet in Patients With Chronic Kidney Disease in Taiwan and Thailand
- Research Article
258
- 10.7326/0003-4819-135-11-200112040-00008
- Dec 4, 2001
- Annals of Internal Medicine
Chronic renal insufficiency leads to muscle wasting, which may be exacerbated by low-protein diets prescribed to delay disease progression. Resistance training increases protein utilization and muscle mass. To determine the efficacy of resistance training in improving protein utilization and muscle mass in patients with chronic renal insufficiency treated with a low-protein diet. Randomized, controlled trial. Tufts University, Boston, Massachusetts. 26 older patients with moderate renal insufficiency (17 men, 9 women) who had achieved stabilization on a low-protein diet. During a run-in period of 2 to 8 weeks, patients were instructed and their adherence to the low-protein diet (0.6 g/kg of body weight per day) was evaluated. They were randomly assigned to a low-protein diet plus resistance training (n = 14) or a low-protein diet alone (n = 12) for 12 weeks. Total body potassium, mid-thigh muscle area, type I and II muscle-fiber cross-sectional area, and protein turnover. Mean protein intake was 0.64 +/- 0.07 g/kg per day after stabilization. Total body potassium and type I and II muscle-fiber cross-sectional areas increased in patients who performed resistance training by a mean (+/-SD) of 4% +/- 8%, 24% +/- 31%, and 22% +/- 29%, respectively, compared with those who did not. Leucine oxidation and serum prealbumin levels also improved significantly. Patients assigned to resistance training maintained body weight compared with those who were not. Improvement in muscle strength was significantly greater with resistance training (32% +/- 14%) than without (-13% +/- 20%) (P < 0.001). By improving muscle mass, nutritional status, and function, resistance training seems to be effective against the catabolism of a low-protein diet and uremia in patients with renal failure.
- Front Matter
1
- 10.1590/2175-8239-jbn-2024-0237en
- Mar 1, 2025
- Jornal brasileiro de nefrologia
The vast majority of patients with advanced chronic kidney disease (CKD) who transition to end-stage kidney disease (ESKD) are treated with dialysis. Given that dialysis does not always have the intended effects of increasing longevity and/or improving health, particularly in those with high comorbidity burden and/or older age groups, there has been increasing emphasis on interventions that delay or avert the need for renal replacement therapy. Among the multi-disciplinary approaches used to reduce CKD progression, dietary interventions are a major cornerstone. Current guidelines support the role of a low-protein diet in patients with moderate to advanced CKD who are metabolically stable. In addition to dietary protein amount, there is evidence that dietary protein sources as well as nutrients in plant-based foods have an important impact on kidney health outcomes. Clinical practice guidelines, including the 2020 National Kidney Foundation and Academy of Nutrition and Dietetics Kidney Disease Outcomes Quality Initiative Clinical Practice Guidelines for Nutrition in CKD, recommend a low protein diet for patients with moderate to advanced non-dialysis dependent (NDD)-CKD who are metabolically stable to reduce risk of ESKD and death. In addition to recommending lower protein intake, the recent 2024 Kidney Disease Improving Global Outcomes CKD Guidelines include a Practice Point advising that people with CKD eat more plant-based foods than animal-based foods. Increasing data also show that plant-based diets are associated with lower risk of progression of CKD and its complications including cardiovascular disease (cardio-kidney-metabolic syndrome), acid-base balance disorders, mineral bone disease, and dysglycemia.
- Research Article
54
- 10.1093/ajcn/nqab417
- May 1, 2022
- The American journal of clinical nutrition
No additional benefit of prescribing a very low-protein diet in patients with advanced chronic kidney disease under regular nephrology care: a pragmatic, randomized, controlled trial
- Front Matter
7
- 10.1053/j.jrn.2023.01.001
- Jan 10, 2023
- Journal of Renal Nutrition
Phytate and Kidney Health: The Roles of Dietary Phytate in Inhibiting Intestinal Phosphorus Absorption and Intravenous Phytate in Decreasing Soft Tissue Calcification
- Research Article
1
- 10.33029/0042-8833-2022-91-2-21-30
- Jan 1, 2022
- Problems of Nutrition
There are no clear dietary recommendations for patients over 70 years of age, while stages 3-5 of chronic kidney disease (CKD) and protein-energy wasting (PEW) is common among this category of patients. Nutritional status is known to be one of the significant factors influencing the prognosis of patients receiving renal replacement therapy. <b>The aim</b> of the research was the analysis of the mechanisms of PEW, methods for assessing the nutritional status and effectiveness of diets with different protein content in patients with CKD based on literature data. <b>Material and methods</b>. The research material was the scientific literature presented in the domestic and international (eLIBRARY, PubMed, Google Scholar) databases, as well as clinical recommendations for the management of geriatric patients with CKD, dietary recommendations for patients with anorexia and other conditions. <b>Results</b>. The studies devoted to the mechanisms of PEW were analyzed. One of the leading causes of this condition is anorexia, in the pathogenesis of which uremic toxins, inflammation and hormonal disorders are involved (hormones such as gastrin, cholecystokinin, leptin, insulin, testosterone and others may be involved in the pathogenesis). A number of studies have shown that limiting protein to 0.6 g/kg day could significantly reduce uremic dyspepsia risk and slow CKD progression. At the same time, several researchers gave data on the ineffectiveness of a low-protein diet in patients with CKD and diabetes mellitus and a significant risk of malnutrition. Subjective global assessment, the mini nutrition assessment and the geriatric nutritional risk index can be distinguished among the methods of assessing nutritional status. <b>Conclusion</b>. Research data on the effectiveness of a low-protein diet in elderly patients with stage 3B-5 CKD are contradictory. PEW in CKD is common and largely determines survival; the mechanism of PEW is complex. The study of the optimal nutritional diet for elderly patients with predialysis stages of CKD still remains an urgent problem.
- Research Article
- 10.14842/jpnjnephrol1959.41.436
- Jan 1, 1999
- Japanese Journal of Nephrology
Low protein diet has been proven to retard the progression of chronic renal failure. In this diet, the energy intake depends mainly on fats and carbohydrates instead of protein, and precautions should be taken against increasing risks of both lipid nephrotoxicity and atherosclerosis. In order to assess the adequacy of fat nutrition in a low protein diet for patients with chronic renal failure, we evaluated the total amounts of dietary fat intake, dietary individual fatty acid intake and serum individual fatty acid concentrations in 16 patients, whose mean creatinine clearance was 21.3 +/- 12.1 ml/m, serum creatinine 3.8 +/- 2.2 mg/dl and serum urea nitrogen 41.5 +/- 18.6 mg/dl. The percentage ratio of fat intake to total energy intake was 26.7 +/- 5.2%. The ratio of intake of saturated fatty acids, monounsaturated fatty acids and polyunsaturated fatty acids was 1:2:1.8, and n-6/n-3 was 8.5 +/- 9.3. These were significant correlations between dietary intake and the serum concentrations in both EPA and the ratio of EPA/AA. Consequently, it might be considered that polyunsaturated fatty acids intake should be lowered and patients with chronic renal failure on a low protein diet should be advised about the proper selection of foods containing animal protein and plant-derived oil. It may be beneficial to recommend the intake of more EPA and lowering the ratio of n-6/n-3 intake might be useful in improving the fat nutrition to adequate levels in these patients.
- Research Article
38
- 10.1053/j.jrn.2014.05.003
- Aug 25, 2014
- Journal of Renal Nutrition
Economic Effects of Treatment of Chronic Kidney Disease With Low-Protein Diet
- Research Article
6
- 10.3390/nu16142230
- Jul 11, 2024
- Nutrients
Low-protein diets (LPDs) seem to improve metabolic complications of advanced CKD, thus postponing kidney replacement therapy (KRT) initiation. However, the nutritional safety of LPDs remains debatable in patients with diabetic kidney disease (DKD), especially in the elderly. This is a sub-analysis of a prospective unicentric interventional study which assessed the effects of LPD in patients with advanced DKD, focusing on the feasibility and safety of LPD in elderly patients. Ninety-two patients with DKD and stable CKD stage 4+, proteinuria >3 g/g creatininuria, good nutritional status, with confirmed compliance to protein restriction, were enrolled and received LPD (0.6 g mixed proteins/kg-day) supplemented with ketoanalogues of essential amino acids for 12 months. Of the total group, 42% were elderly with a median eGFR 12.6 mL/min and a median proteinuria 5.14 g/g creatininuria. In elderly patients, proteinuria decreased by 70% compared to baseline. The rate of kidney function decline was 0.1 versus 0.5 mL/min-month before enrolment. Vascular events occurred in 15% of cases, not related to nutritional intervention, but to the severity of CKD and higher MAP. LPDs seem to be safe and effective in postponing KRT in elderly patients with advanced DKD while preserving the nutritional status.
- Research Article
- 10.1093/ndt/gfae069.172
- May 23, 2024
- Nephrology Dialysis Transplantation
Background and Aims Starting peritoneal dialysis (PD) with an incremental approach, that is, a low dose of PD (1-2 dwells a day in continuous ambulatory PD and until 5 sessions a week in automated PD) based on residual kidney function, is a common strategy to increase the acceptance of dialysis for patients affected by advanced chronic kidney disease (CKD) requiring renal replacement therapy. However, no study has provided evidence on the optimal protein intake in patients treated with a low dose of PD. Indeed, patients starting dialysis require an increased protein intake to supply protein loss by dialysis. On the other hand, patients beginning with a low dose of dialysis and a high protein intake may lead to toxins accumulation and metabolic acidosis. Therefore, the maintenance of protein restriction could be indicated as long as malnutrition does not occur. Method The I-COPE study was designed to assess in 24 PD units in Italy the time to full-dose PD in patients undergoing integrated conservative therapy with low-dose PD. Patients who reached full-dose, switched to hemodialysis, received transplant, or died were censored. No specific recommendation on protein intake was included in the study protocol due to the lack of guidelines on this issue, so the prescription was left to decision of each participating center. This is an ad-interim analysis of the I-COPE study aimed at evaluating the longitudinal changes at one year of BMI and serum albumin. Two groups of nutritional interventions were identified a posteriori: non-low protein diet (NLPD, dietary protein intake &gt; 0.6 g/Kg/day) vs low protein diet (LPD, dietary protein intake ≤ 0.6 g/Kg/day) on two visits after baseline (months 6 and 12). We used a mixed linear regression model to evaluate changes in variables over time in the two diet groups, assuming an unstructured covariance matrix; this was done to consider the correlation between repeated measures and missing points for patients not completing the analysis. Results The I-COPE study included 222 patients (age 63.6 ± 14.2 ys, males 65.3%, diabetes 29.2%). LPD was prescribed in 46.3%, while NLPD in 53.7%. At baseline, no intergroup difference was reported for age (P = 0.51), gender (P = 0.94), and diabetes (P = 0.11). 150 patients had at least an evaluation after baseline. The mixed regression model showed no difference in BMI (P = 0.668) and serum albumin (P = 0.297) adjusted for age, gender, diabetes, and GFR at the start of dialysis. As depicted in Fig. 1, serum albumin level was maintained at 12 months in either group. Conclusion We provide first-time observation that LPD may be safely associated with stable serum albumin and BMI over one year of incremental PD treatment. Therefore, in patients with advanced CKD requiring renal replacement therapy, LPD combined with a low dose of PD may provide a suitable nutritional approach to reduce waste metabolic products without increasing the risk of malnutrition.
- Research Article
3
- 10.31989/ffhd.v3i7.47
- Jul 7, 2013
- Functional Foods in Health and Disease
Background: Several clinical studies have shown that a low protein diet in patients with Chronic Kidney Disease (CKD), delays the natural progression of the end stage renal disease (ESRD) and the necessary treatment of chronic dialysis.Objective: The aim of this study is to estimate the cost-effectiveness of a low protein diet compared with no dietary treatment in patients with CKD stage 4 and 5 after 2, 3, 5 and 10 years.Method: A Markov model was developed to estimate costs and QALYs associated with low protein diet versus no treatment for patients with CKD stage 4-5. The transition probability was estimated on data from seven studies which determined the efficacy of low protein diets in delaying the need to start maintenance dialysis. The Quality Adjusted Life Years (QALYs) scores used were estimated with the Time Trade Off technique. The annual cost of dialysis per patient was estimated to be approximately €34,072. The costs of a low-protein diet was €1,440 per patient per year in the Lazio Region (conservative assumptions). Results: Treatment with a low-protein diet was more effective in terms of QALYs: the difference was always in favour of dietary treatment from a 0.09 QALYS after the first two years, 0.16 after three years, 0.36 after five years and up to a differential of 0.93 year after the first 10 years of treatment. In terms of cost-effectiveness, the dietary treatment was always dominant in all intervals considered. The dominance is due to the fact that the treatment is more effective in terms of QALYs and at the same time is less expensive.Conclusion: The results of these simulations indicate that the treatment of CKD patients with a low protein diet is cost effective relative to no treatment in an Italian setting. Further studies should test this model in other countries with different dialysis costs and dietary support.Key words: chronic kidney disease, low-protein diet, cost-effectiveness of a low protein diet
- Research Article
- 10.3760/cma.j.issn.1674-635x.2012.05.004
- Oct 30, 2012
- 中华临床营养杂志
Objective To evaluate the effects of continuous quality improvement (CQI) management on nutritional status,renal function progression,and compliance of low protein diet in patients with chronic kidney disease (CKD).Methods Totally 115 CKD patients who were regularly followed up in CKD clinic services were recruited in this study.Plan,Do,Check,and Act (PDCA) method was adopted to manage the dietary of these patients for 12 months.The clinical indicators and diet compliance before and after receiving CQI management were compared.Results After receiving the CQI management,the nutritional status of patients was well maintained;meanwhile,the average hand strength and the hemoglobin,serum albumin,total cholesterol,and triglyceride levels showed no significant changes (all P > 0.05).Subjective feelings of patients were improved.The modified Subjective Global Assessment of Nutrition (mSGA) score was decreased from 7.0 (7.0,8.0) to 7.0 (7.0,7.0) (P =0.000).The estimated glomerular filtration rate (eGFR) calculated by formula of modified MDRD was decreased from (40.74 ± 14.49) to (37.94 ± 16.86) ml/(min · 1.73 m2) (P =0.000),and the average descended speed was (2.81 ±7.42) ml/(min · 1.73 m2) per year.The creatinine clearance rate had no statistical difference between pre-and post management (P =0.910),and the average descended speed was (0.19 ± 17.01) ml/min per year.The daily protein intake (DPI) and protein equivalent of nitrogen appearance rate (PNA) were both significandy descended:DPI/kg decreased from (0.79 ± 0.27) to (0.64 ± 0.15) g/ (24 h · kg) (P =0.000),and PNA/kg dropped from (1.02 ± 0.32) to (0.82 ± 0.24) g/ (24 h · kg) (P =0.000).The scores of awareness and compliance of patients on low protein diet were significantly increased after CQI management (P =0.000).Conculsion Applying CQI on dietary and nutrition management in CKD patients can maintain the good nutritional status and improve the compliance of low protein diet. Key words: Chronic kidney disease; Continuous quality improvement; Nutrition; Low protein diet
- Research Article
3
- 10.2139/ssrn.2338432
- Oct 10, 2013
- SSRN Electronic Journal
Economic Effects of Treatment of Chronic Kidney Disease with Low-Protein Diet