Finerenone Dose-Exposure-Response for the Primary Kidney Outcome in FIDELIO-DKD Phase III: Population Pharmacokinetic and Time-to-Event Analysis.

Paul van den BergMartijn RuppertEmir MesicNelleke SnelderAndreas SeelmannRoland HeinigAmer JosephDirk GarmannJoerg LippertThomas Eissing

Published in: Clinical pharmacokinetics (2021)

None of the tested pharmacokinetic covariates had clinical relevance in FIDELIO-DKD. Finerenone effects on kidney outcomes approached saturation towards 20 mg once daily and sodium-glucose transport protein 2 inhibitor use provided additive benefits.

Keyphrases

phase iii
open label
clinical trial
double blind
phase ii
physical activity
protein protein
small molecule
binding protein
insulin resistance