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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.

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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

FieldValue
Enrollment Target 518 participants
Start Date 2021-01-25
Est. Completion 2025-09-19
Phase Phase 3

Sponsor

Novartis Pharmaceuticals

1,375 total trials

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.

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.