Original InvestigationDialysisSevelamer Versus Calcium Carbonate in Incident Hemodialysis Patients: Results of an Open-Label 24-Month Randomized Clinical Trial
Section snippets
Study Participants
A detailed description of the INDEPENDENT (Reduce Cardiovascular Calcifications to Reduce QT Interval in Dialysis) Study has been published elsewhere.21 Study participants were randomly assigned in a 1:1 fashion to receive either sevelamer hydrochloride or a calcium-containing phosphate binder (although not required by the protocol, all patients in this group received calcium carbonate; Fig 1). Adult (aged >18 years) patients with CKD stage 5 new to hemodialysis (requiring dialysis <120 days)
Results
A total of 466 patients were randomly assigned to treatment with either sevelamer (n = 232) or a calcium-containing phosphate binder (n = 234). Of these, 33 (14.2%) in the sevelamer arm and 36 (15.3%) in the calcium carbonate arm exited the study for various reasons prior to study completion, for a drop-out rate <5% per year (Fig 1). Enrollment and drop-out rates were well balanced across all sites (Table S1). Mean age of the study cohort was 65 ± 14 years. Men and women were represented
Discussion
In this study, a large cohort of incident hemodialysis patients was randomly assigned to receive either sevelamer or calcium carbonate for treatment of hyperphosphatemia. The primary objective of the study was to test the impact of phosphate-binder assignment on CV mortality due to cardiac arrhythmias and secondarily on all-cause CV mortality and all-cause mortality. Previous randomized clinical trials have shown that sevelamer may significantly attenuate the progression of CV calcification in
Acknowledgements
The INDEPENDENT Study Investigators are as follows: Filippo Aucella (S. Giovanni Rotondo), Pasquale Guastaferro, Angela Di Gianni (S. Angelo Dè Lombardi), Luigi Chiuchiulo (Avellino, Dyalysis), Roberto Rubino (Ariano Irpino), Lucia Di Micco (Napoli), Vincenzo Tedesco (Montella), Mario Migliorati (S. Giorgio A Cremano), Walter De Simone, Bruno Zito (Avellino), Ernesto D'avanzo, Francesco Saverio Iannaccone (Solofra: Radiologia), Maria Luisa Sirico (Caserta), Patrizia Veniero, Maria Capuano,
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Cited by (151)
Phosphorus metabolism and fibroblast growth factor 23 in chronic kidney disease
2021, Nutritional Management of Renal Disease, Fourth EditionState-of-the-Art Management of Hyperphosphatemia in Patients With CKD: An NKF-KDOQI Controversies Perspective
2021, American Journal of Kidney DiseasesTime to Reconsider Calcium-Based Phosphate Binders in Dialysis? A Call for a Well-Designed Randomized Controlled Trial
2020, American Journal of Kidney DiseasesSevelamer Use and Mortality in People with Chronic Kidney Disease Stages 4 and 5 Not on Dialysis
2023, Journal of Clinical Medicine
Originally published online May 20, 2013.
Corrected online July 30, 2013. See Item S1 in “Supplementary Material” online for an explanation of the corrections. The errors have been corrected in the print, PDF, and HTML versions of this article.
Trial registration: www.ClinicalTrials.gov; study number: NCT00710788.
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Deceased.
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A list of the INDEPENDENT Study Investigators appears in the Acknowledgements.