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NCT04557462 · ClinicalTrials.gov registry record · Phase 3
A Rollover Extension Program (REP) to Evaluate the Long-term Safety and Tolerability of Open Label Iptacopan/LNP023 in Participants With Primary IgA Nephropathy
A Phase 3 study of Primary IgA Nephropathy, sponsored by Novartis Pharmaceuticals.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 540
- Enrollment target
- 20
- Study locations
NCT04557462 is a Phase 3 study of Primary IgA Nephropathy that is actively recruiting participants, run by Novartis Pharmaceuticals. The registered enrollment target is 540 participants. The trial reports 20 study locations across 16 states.
The verdict
NCT04557462, a Phase 3 study of Primary IgA Nephropathy, is actively recruiting participants, sponsored by Novartis Pharmaceuticals.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 540 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to evaluate the long-term safety and tolerability, of open label iptacopan in primary IgA nephropathy participants who have completed either the CLNP023X2203 or CLNP023A2301 clinical trials. The open-label design of the current study is appropriate to provide study participants the opportunity to receive treatment with iptacopan until marketing authorizations are received and the drug product becomes commercially available while enabling collection of long-term safety and tolerability data for the investigational drug. Furthermore efficacy assessments conducted every 6 months will afford the opportunity to evaluate the clinical effects of iptacopan on long-term disease progression.
Conditions Studied
Interventions
- DRUG LNP023
Study Locations (20)
California
- Kaiser Permanente - San Diego
- North America Research Institute - San Dimas
Texas
- Dallas Renal Group - Dallas
- Prolato Clinical Research Center - Houston
Córdoba Province
- Novartis Investigative Site - Córdoba
- Novartis Investigative Site - Córdoba
Other
- Novartis Investigative Site - CABA
- Novartis Investigative Site - CABA
Arizona
- AZ Kidney Dise and Hypertension Ctr - Glendale
Colorado
- University of Colorado Anschutz - Aurora
Delaware
- Nephrology Associates PA - Newark
Idaho
- CaRe Research - Chubbuck
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 540 participants |
| Start Date | 2021-09-20 |
| Est. Completion | 2032-10-25 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04557462
The ClinicalTrials.gov registry entry for NCT04557462 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 540 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 1 condition, with Primary IgA Nephropathy appearing as the primary indexed condition, and to 1 intervention - of which LNP023 is the first listed.
NCT04557462 reports 20 study locations spanning 16 distinct geographic areas - top geographies include California, Texas, Córdoba Province.
Frequently Asked Questions
What is clinical trial NCT04557462 about?
NCT04557462 is a clinical study titled "A Rollover Extension Program (REP) to Evaluate the Long-term Safety and Tolerability of Open Label Iptacopan/LNP023 in Participants With Primary IgA Nephropathy". The purpose of this study is to evaluate the long-term safety and tolerability, of open label iptacopan in primary IgA nephropathy participants who have completed either the CLNP023X2203 or CLNP023A2301 clinical trials. The open-label design of the current study is appropriate to provide study parti...
What is the current status of trial NCT04557462?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 540 participants. The study started on 2021-09-20. Estimated completion is 2032-10-25.
What conditions does trial NCT04557462 study?
This clinical trial studies the following conditions: Primary IgA Nephropathy.
What interventions are being tested in trial NCT04557462?
The interventions under investigation include: LNP023 (DRUG).
Who is sponsoring clinical trial NCT04557462?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04557462 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Delaware, Idaho. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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