Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04541043 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety in Patients With Primary IgA Nephropathy Who Have Completed Study Nef-301 (Nefigard-OLE)
A Phase 3 study, sponsored by Calliditas Therapeutics AB.
- Completed
- Registry status
- Phase 3
- Development phase
- 119
- Enrollment target
NCT04541043 is a Phase 3 study that has completed, run by Calliditas Therapeutics AB. The registered enrollment target is 119 participants.
The verdict
NCT04541043, a Phase 3 study, has completed, sponsored by Calliditas Therapeutics AB.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 119 participants
- Enrollment target
Study Summary
This is a Phase 3b, multicenter, open-label extension (OLE) study to evaluate the efficacy and safety of Nefecon treatment in patients with IgAN who have completed the Phase 3 Study Nef-301 and continue to be treated with a stable dose of RAS inhibitor therapy (ACEIs and/or ARBs). Patients who previously received Nefecon in Study Nef-301 will receive retreatment, whereas patients who previously received placebo in Study Nef-301 will be treatment naïve to Nefecon.
Interventions
- DRUG Nefecon 16mg daily
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 119 participants |
| Start Date | 2020-11-17 |
| Est. Completion | 2024-02-26 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04541043
The ClinicalTrials.gov registry entry for NCT04541043 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 119 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Calliditas Therapeutics AB, which has 5 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Nefecon 16mg daily is the first listed.
NCT04541043 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04541043 about?
NCT04541043 is a clinical study titled "Efficacy and Safety in Patients With Primary IgA Nephropathy Who Have Completed Study Nef-301 (Nefigard-OLE)". This is a Phase 3b, multicenter, open-label extension (OLE) study to evaluate the efficacy and safety of Nefecon treatment in patients with IgAN who have completed the Phase 3 Study Nef-301 and continue to be treated with a stable dose of RAS inhibitor therapy (ACEIs and/or ARBs). Patients who previ...
What is the current status of trial NCT04541043?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 119 participants. The study started on 2020-11-17. Estimated completion is 2024-02-26.
What interventions are being tested in trial NCT04541043?
The interventions under investigation include: Nefecon 16mg daily (DRUG).
Who is sponsoring clinical trial NCT04541043?
This trial is sponsored by Calliditas Therapeutics AB, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
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.