Safety Tolerability and Efficacy of Nidufexor in Patients With Diabetic Nephropathy

  • STATUS
    Recruiting
  • End date
    May 18, 2022
  • participants needed
    116
  • sponsor
    Novartis Pharmaceuticals
Updated on 1 September 2021
diabetes
enzyme inhibitors
type 2 diabetes mellitus
ace inhibitor
angiotensin
nephropathy
angiotensin converting enzyme
diabetic nephropathy

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.

Details
Condition Diabetic Nephropathy, Nephropathy, Kidney Disease (Pediatric), Kidney Disease, Diabetic Kidney Disease
Treatment Placebo, LMB763
Clinical Study IdentifierNCT03804879
SponsorNovartis Pharmaceuticals
Last Modified on1 September 2021

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