Different eGFR Decline Thresholds and Renal Effects of Canagliflozin: Data from the CANVAS Program.

ABSTRACT:

Background

Traditionally, clinical trials evaluating effects of a new therapy with creatinine-based renal end points use doubling of serum creatinine (equivalent to a 57% eGFR reduction), requiring large sample sizes.

Methods

To assess whether eGFR declines <57% could detect canagliflozin's effects on renal outcomes, we conducted a post hoc study comparing effects of canagliflozin versus placebo on composite renal outcomes using sustained 57%, 50%, 40%, or 30% eGFR reductions in conjunction with ESKD and renal death. Because canagliflozin causes an acute reversible hemodynamic decline in eGFR, we made estimates using all eGFR values as well as estimates that excluded early measures of eGFR influenced by the acute hemodynamic effect.

Results

Among the 10,142 par

SUBMITTER: Oshima M 

PROVIDER: S-EPMC7609006 | biostudies-literature | 2020 Oct

REPOSITORIES: biostudies-literature