Leveraging pragmatic clinical trial design to advance phosphate management in end-stage renal disease.

Abstract:

PURPOSE OF REVIEW:Phosphate lowering toward the normal range is advocated and widely practiced in patients with end-stage renal disease receiving dialysis. This approach is guided by basic science data and large observational studies that have demonstrated a consistent association between hyperphosphatemia and adverse events, including cardiovascular morbidity and all-cause mortality. There has never been a clinical trial to assess the efficacy of phosphate lowering in maintenance dialysis recipients. RECENT FINDINGS:Despite several trials comparing the effect of different phosphate-binding agents on biochemical targets, no trial has evaluated whether targeting normophosphatemia using phosphate binders mediates better patient outcomes. Recent work has highlighted the feasibility of conducting a randomized trial comparing two strategies for phosphate control. We believe that this research question is optimally suited to a pragmatic trial design. SUMMARY:There is a pressing need for a well-designed randomized controlled trial to evaluate whether intensive phosphate lowering confers improved cardiovascular outcomes in patients receiving maintenance dialysis. We propose a broad framework for such a trial using the principles of pragmatic trial design. The ultimate objective of such a trial will be to provide patients and clinicians with reliable and broadly applicable information on whether reducing serum phosphate toward the normal range improves patient-important outcomes.

authors

Wald R,Thorpe KE,Walsh MW

doi

10.1097/MNH.0000000000000460

subject

Has Abstract

pub_date

2019-01-01 00:00:00

pages

34-39

issue

1

eissn

1062-4821

issn

1473-6543

pii

00041552-201901000-00006

journal_volume

28

pub_type

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