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Activity Number: 353
Type: Contributed
Date/Time: Tuesday, August 11, 2015 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract #317600 View Presentation
Title: Tipping Point Analysis for Tolvaptan Clinical Study in Patients with ADPKD
Author(s): John Ouyang* and Junfang Li and Matilda Hsieh
Companies: Otsuka and and Otsuka
Keywords: Missing Data ; imputation ; Tolvapatan
Abstract:

In a phase 3, multicenter, double-blind, placebo-controlled, 3-year trial, 1445 subjects, who had autosomal dominant polycystic kidney disease (ADPKD) with a total kidney volume of ?750 ml, an estimated creatinine clearance ? 60 ml per minute, were randomized in a 2:1 ratio to receive tolvaptan, a V2-receptor antagonist, at the highest of three twice-daily dose regimens that the patient found tolerable, or placebo. The primary outcome was the annual rate of change in the total kidney volume (TKV). Sequential secondary end points included a composite of time to clinical progression (defined as worsening kidney function, kidney pain, hypertension, and albuminuria) and rate of kidney-function decline. Over a 3-year period, the increase in total kidney volume in the tolvaptan group was 2.8% per year (95% confidence interval [CI], 2.5 to 3.1), versus 5.5% per year in the placebo group (95% CI, 5.1 to 6.0; P< 0.001). The composite clinical end point favored tolvaptan over placebo (44 vs. 50 events per 100 follow-up-years, P = 0.01). Tolvaptan was associated with a slower decline in kidney function (reciprocal of the serum creatinine level, ?2.61 [mg/ per milliliter]?1 per year vs. ?3.8


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