Overview

Safety, Tolerability and Efficacy of Nidufexor in Patients With Diabetic Nephropathy

Status:
Completed
Trial end date:
2021-05-03
Target enrollment:
Participant gender:
Summary
Nidufexor addresses fibrosis, oxidative stress, inflammation and cell death, and therefore has the potential to improve the management of diabetic kidney disease when added to the standard of care (angiotensin converting enzyme inhibitor or angiotensin receptor blocker). This non-confirmatory Phase 2 study is designed to determine the safety, tolerability, efficacy, pharmacokinetics and pharmacodynamics of nidufexor in combination with angiotensin converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB) at a dose level that is standard of care as judged by the study doctor in patients with type 2 diabetes and nephropathy.
Phase:
Phase 2
Details
Lead Sponsor:
Novartis Pharmaceuticals