Trial intelligence / Profile preview

ASP8232 in Renal Impairment and T2DM with CKD

NCT02218099Phase 2

Key facts

Status: Completed
Start: Sep 2013
Primary completion: Sep 2014
Countries: 3
Sponsor: Astellas Pharma
Modality: Small Molecules

Drugs: ASP8232
Conditions: diabetic kidney disease (DKD)

Overview

Phase 2, randomised, double-blind trial of ASP8232 in diabetic kidney disease (DKD) (3 arms), sponsored by Astellas Pharma. Primary endpoints: Area Under the Curve from zero to infinity, Area Under the Curve to last time point and 2 more. Started Sep 2013; status: completed.

Design

3 arms

Study design: RandomizedDouble-blind

Part 1: Single Dose
Healthy and Renal Impaired subjects receiving single dose ASP8232
Part 2: ASP8232
T2DM+CKD subjects receiving multiple doses of ASP8232
Part 2: Placebo
T2DM+CKD subjects receiving Placebo

Who it enrols

Part 1 includes healthy subjects and subjects with renal impairment (eGFR 15-80). Part 2 includes subjects with T2DM and CKD (eGFR 15-60, UACR > 30 mg/g) on stable ACEi/ARB therapy.

Endpoints

Primary

Area Under the Curve from zero to infinityDay 1 to Day 56
Area Under the Curve to last time pointDay 1 to Day 56
Maximum ConcentrationDay 1 to Day 56
Safety and tolerability measured by AEs, vital signs, labs, ECGScreening to End of Study Visit

Secondary

Vascular adhesion protein-1 activity in plasmaDay -2 to ESV
Total antioxidant status in serumDay -2 to ESV
24-hour urinary albumin excretion rateDay 28

Beyond the preview

Go deeper on NCT02218099.

Full results, competitive context and analysis are in the Gosset platform.

Full results & analysis

Available in the Gosset platform where reported.

Competitive context

Available in the Gosset platform where reported.

Bring the full picture into focus.

See how Gosset can support your research on NCT02218099.