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A Rollover Extension Program (REP) to Evaluate the Long-term Safety and Tolerability of Open Label Iptacopan/LNP023 in Participants With Primary IgA Nephropathy
NCT04557462 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. 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 792 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04557462 reports 20 study locations spanning 16 distinct geographic areas — top geographies include California, Texas, Córdoba Province. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04557462?
The interventions under investigation include: LNP023 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04557462?
This trial is sponsored by Novartis Pharmaceuticals, which has 792 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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