NCT04026165

Study to Evaluate the Efficacy and Safety of Selonsertib in Participants With Moderate to Advanced Diabetic Kidney Disease

MOSAIC - A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Study Evaluating the Efficacy and Safety of Selonsertib in Subjects With Moderate to Advanced Diabetic Kidney Disease

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 384 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to evaluate whether selonsertib (SEL) can slow the decline in kidney function in participants with moderate to advanced diabetic kidney disease (DKD).

Detailed description

Following the screening period, eligible participants will enroll into a Run-in period of at least 5 weeks and receive placebo to match SEL for at least 1 week and then SEL for at least 4 weeks. After completing Run-in period, eligible participants will be randomized and receive either SEL or placebo to match SEL for at least 48 weeks.

Conditions

• Diabetic Kidney Disease

Interventions

Type	Name	Description
DRUG	SEL	Tablet administered orally once daily
DRUG	Placebo	Tablet administered orally once daily

Timeline

• Start date: 2019-07-24
• Primary completion: 2021-09-03
• Completion: 2021-09-03
• First posted: 2019-07-19
• Last updated: 2022-12-21
• Results posted: 2022-12-21

Locations

111 sites across 5 countries: United States, Australia, Canada, Japan, New Zealand

Regulatory

• FDA-regulated drug study