Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Recruiting Phase 3 study of Primary IgA Nephropathy, sponsored by Novartis Pharmaceuticals.
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, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (30% lower). The trial reports 20 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Summary statistics on serious adverse events
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 |
What NCT04557462 shows while recruiting
NCT04557462 is an interventional study that assigns participants to a tested intervention. The registered 540 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 (30% lower).
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 names 20 study sites across 16 states, led by 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.
Learn More About Clinical Trials
Similar trials for Primary IgA Nephropathy
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04557462's enrollment target sits among peer trials
540 694th of 2000 higher than 1,302 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04956640 · 540 participants · Phase 1
Study of LY3537982 in Cancer Patients With a Specific Genetic Mutation (KRAS G12C)
- NCT05429892 · 540 participants · NA
FRESH Delivers: An Innovative Approach to Reducing Tobacco Use Among Rural Smokers
- NCT05549297 · 540 participants · Phase 3
Tebentafusp Regimen Versus Investigator's Choice in Previously Treated Advanced Melanoma (TEBE-AM)
- NCT05588245 · 540 participants · NA
Trial of Community-based Patient Navigation
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI