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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: Completed Phase 3 study, sponsored by Calliditas Therapeutics AB.
NCT04541043 is a Phase 3 study that has completed, run by Calliditas Therapeutics AB. The registered enrollment target is 119 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The outcome is measured as UPCR based on 24 hour urine collections at 9 months following the first dose of Nefecon compared to baseline Ratio being: UPCR at 9 months in g/gram divided with UPCR at Baseline in g/gram
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 |
What the finished NCT04541043 record still lists
NCT04541043 is an interventional study that assigns participants to a tested intervention. The registered 119 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 (85% lower).
The record links to 0 conditions, and to 1 intervention - of which Nefecon 16mg daily is the first listed.
NCT04541043 does not publish any study locations in the registry export this page uses.
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
How this trial's enrollment target compares
Where NCT04541043's enrollment target sits among peer trials
119 1640th of 2000 higher than 360 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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