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

NCT03804879 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 83

Last updated 2022-08-10

Study results available
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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 (SoC) (angiotensin converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB)).

This non-confirmatory Phase 2 study was designed to determine the safety, tolerability, efficacy, pharmacokinetics and pharmacodynamics of nidufexor in combination with ACEI or ARB at a dose level that is SoC as judged by the study doctor in patients with type 2 diabetes and nephropathy.

Conditions

  • Diabetic Nephropathy

Interventions

DRUG

Nidufexor

50 mg (two 25 mg) LMB763 capsules for oral administration

OTHER

Placebo

Placebo capsules for oral administration

DRUG

Standard of Care (SoC)

Optimal tolerated doses of angiotensin converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB)

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-17
Primary Completion
2021-05-03
Completion
2021-05-03
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Czechia
  • Germany
  • Jordan
  • Lebanon
  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03804879 on ClinicalTrials.gov