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NCT04578834 · ClinicalTrials.gov registry record · Phase 3
Study of Efficacy and Safety of LNP023 in Primary IgA Nephropathy Patients
A Phase 3 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 518
- Enrollment target
NCT04578834: Completed Phase 3 study, sponsored by Novartis Pharmaceuticals.
NCT04578834 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 518 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (33% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04578834, a Phase 3 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 518 participants
- Enrollment target
Study Summary
The study is designed as a multicenter, randomized, double-blind, placebo controlled study to demonstrate the superiority of iptacopan (LNP023) at a dose of 200 mg b.i.d. compared to placebo on top of maximally tolerated ACEi or ARB on reduction of proteinuria and slowing renal disease progression in primary IgA Nephropathy patients.
Primary Outcome
Evaluated at interim analysis - To demonstrate superiority of LNP023 vs. placebo in the change of proteinuria at 9 months by measuring Urine Protein to Creatinine Ratio sampled from a 24h urine collection.
Interventions
- DRUG Placebo
- DRUG LNP023
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 518 participants |
| Start Date | 2021-01-25 |
| Est. Completion | 2025-09-19 |
| Phase | Phase 3 |
What the finished NCT04578834 record still lists
NCT04578834 is an interventional study that assigns participants to a tested intervention. The registered 518 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (33% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04578834 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04578834 about?
NCT04578834 is a clinical study titled "Study of Efficacy and Safety of LNP023 in Primary IgA Nephropathy Patients". The study is designed as a multicenter, randomized, double-blind, placebo controlled study to demonstrate the superiority of iptacopan (LNP023) at a dose of 200 mg b.i.d. compared to placebo on top of maximally tolerated ACEi or ARB on reduction of proteinuria and slowing renal disease progression i...
What is the current status of trial NCT04578834?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 518 participants. The study started on 2021-01-25. Estimated completion is 2025-09-19.
What interventions are being tested in trial NCT04578834?
The interventions under investigation include: Placebo (DRUG), LNP023 (DRUG).
Who is sponsoring clinical trial NCT04578834?
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 NCT04578834's enrollment target sits among peer trials
518 723rd of 2000 higher than 1,277 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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