Per-Treatment Post Hoc Analysis of Clinical Trial Outcomes With Tolvaptan in ADPKD.

ABSTRACT:

Introduction

In pivotal trials of patients with autosomal dominant polycystic kidney disease at risk of rapid progression, tolvaptan slowed estimated glomerular filtration rate (eGFR) decline in early-to-moderate (TEMPO 3:4 [NCT00428948]) and moderate- to late-stage (REPRISE [NCT02160145]) chronic kidney disease (CKD). Discontinuation was less frequent in REPRISE (15.0%) than TEMPO 3:4 (23.0%), given that in REPRISE, only subjects who tolerated tolvaptan 60/30 mg daily initiated the double-blind phase. We evaluated whether the greater treatment effect in REPRISE was attributable to different completion rates.

Methods

We conducted post hoc analyses of TEMPO 3:4 and REPRISE completers, defined as subjects who took trial drug to the end of the treatment period in TEMPO 3

SUBMITTER: Mallett AJ 

PROVIDER: S-EPMC8071614 | biostudies-literature | 2021 Apr

REPOSITORIES: biostudies-literature