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NCT03804879 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study, sponsored by Novartis Pharmaceuticals.

Completed
Registry status
Phase 2
Development phase
83
Enrollment target

NCT03804879 is a Phase 2 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 83 participants.

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The verdict

NCT03804879, a Phase 2 study, has completed, sponsored by Novartis Pharmaceuticals.

COMPLETED
Registry status
Phase 2
Development phase
83 participants
Enrollment target

Study 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.

Interventions

  • OTHER Placebo
  • DRUG Nidufexor
  • DRUG Standard of Care (SoC)

Trial Details

FieldValue
Enrollment Target 83 participants
Start Date 2018-12-17
Est. Completion 2021-05-03
Phase Phase 2

Sponsor

Novartis Pharmaceuticals

1,375 total trials

What the Registry Record Tells You About NCT03804879

The ClinicalTrials.gov registry entry for NCT03804879 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 83 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.

NCT03804879 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT03804879 about?

NCT03804879 is a clinical study titled "Safety, Tolerability and Efficacy of Nidufexor in Patients With Diabetic Nephropathy". 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...

What is the current status of trial NCT03804879?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 83 participants. The study started on 2018-12-17. Estimated completion is 2021-05-03.

What interventions are being tested in trial NCT03804879?

The interventions under investigation include: Placebo (OTHER), Nidufexor (DRUG), Standard of Care (SoC) (DRUG).

Who is sponsoring clinical trial NCT03804879?

This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.