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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 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 518 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04578834
The ClinicalTrials.gov registry entry for NCT04578834 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 518 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 2 interventions - of which Placebo is the first listed.
NCT04578834 reports 0 study locations.
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.
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