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Abstract
BackgroundElevated serum level of fibroblast growth factor-23 (FGF23) is associated with adverse outcomes in dialyzed patients.ObjectivesThe CUPID study compared the efficacy of a cinacalcet-based regimen with conventional care (vitamin D and P binders) for achieving the stringent NKF-K/DOQI targets for peritoneal dialysis (PD) patients. Additionally, we analyzed change in FGF23 levels between two treatments to explore the cinacalcet effect in lowering FGF23.DesignMulticenter, open-labeled, randomized controlled study.SettingSeven university-affiliated hospitals in Korea.ParticipantsOverall, 66 peritoneal dialysis patients were enrolled.InterventionSixty six patients were randomly assigned to treatment with either cinacalcet + oral vitamin D (cinacalcet group, n = 33) or oral vitamin D alone (control group, n = 33) to achieve K/DOQI targets. CUPID included a 4-week screening for vitamin D washout, a 12-week dose-titration, and a 4-week assessment phases. We calculated mean values of iPTH, Ca, P, Ca x P, during assessment phase and final FGF23 to assess the outcome.Main outcome measuresAchievement of >30% reduction of iPTH from baseline (primary) and FGF23 reduction (secondary).Results72.7% (n = 24) of the cinacalcet group and 93.9% (n = 31) of the control group completed the study. Cinacalcet group received 30.2 ± 18.0 mg/day of cinacalcet and 0.13 ± 0.32 μg/d oral vitamin D (P < 0.001 vs. control with 0.27 ± 0.18 μg/d vitamin D). The proportion of patients who reached the primary endpoint was not statistically different (48.5% vs. 51.5%, cinacalcet vs. control, P = 1.000). After treatment, cinacalcet group experienced a significant reduction in FGF23 levels (median value from 3,960 to 2,325 RU/ml, P = 0.002), while an insignificant change was shown for control group (from 2,085 to 2,415 RU/ml). The percent change of FGF23 after treatment was also significantly different between the two groups (− 42.54% vs. 15.83%, P = 0.008). After adjustment, cinacalcet treatment was independently associated with the serum FGF23 reduction.ConclusionCinacalcet treatment was independently associated with the reduction of FGF23 in our PD patients.Trial registrationControlled trials NCT01101113
Highlights
Elevated serum level of fibroblast growth factor-23 (FGF23) is associated with adverse outcomes in dialyzed patients
In advanced chronic kidney disease (CKD), FGF23 no longer maintains phosphate homeostasis and the suppression of 1,25(OH)2D production exerted by FGF23 induces parathyroid hormones (PTH) elevation, resulting in secondary hyperparathyroidism (SHPT)
Patients were considered for the study if they were ≥18 and ≤70 years of age, had received peritoneal dialysis (PD) for ≥3 months and with pre-screening intact PTH ≥300 pg/ml (≥250 pg/ml if they had been taking vitamin D analogs) and albumin– corrected calcium ≥9.0 mg/dl
Summary
Elevated serum level of fibroblast growth factor-23 (FGF23) is associated with adverse outcomes in dialyzed patients. Fibroblast growth factor-23 (FGF23) is an endocrine hormone that regulates phosphate and vitamin D homeostasis. FGF23 inhibits phosphate reabsorption in the renal tubule and promotes phosphaturia by down-regulating sodium-phosphate co-transporters [3]. It decreases renal production of 1,25 (OH)2D by inhibiting 1α-hydroxylase and up-regulating 24-hydroxylase in the proximal tubule [3,4]. As kidney function decreases in chronic kidney disease (CKD) patients, FGF23 increases progressively in order to regulate phosphate homeostasis [5]. FGF23 elevation is associated with increased mortality in CKD and ESRD patients [11]. Several studies reported that cinacalcet reduced FGF23 in predialysis or hemodialysis patients [12,13]
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