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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: Completed Phase 2 study, sponsored by Novartis Pharmaceuticals.
NCT03804879 is a Phase 2 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 83 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (38% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
UACR is a ratio between albumin and creatinine, and it estimates 24-hour urine albumin excretion. UACR (mg/mmol) = urine albumin \[mg/L\] / urine creatinine \[mmol/L\]. UACR was analyzed on a log-scale fitting a repeated measures mixed model including treatment and visit as fixed effects and log of baseline as continuous covariate. Baseline is the last measurement prior to treatment administration. No methods for imputation of missing data were used. Values reported were back-transformed to ori
Interventions
- OTHER Placebo
- DRUG Nidufexor
- DRUG Standard of Care (SoC)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 83 participants |
| Start Date | 2018-12-17 |
| Est. Completion | 2021-05-03 |
| Phase | Phase 2 |
What the finished NCT03804879 record still lists
NCT03804879 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 83 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (38% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT03804879 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03804879's enrollment target sits among peer trials
83 828th of 2000 higher than 1,171 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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