A Rollover Extension Program (REP) to Evaluate the Long-term Safety and Tolerability of Open Label Iptacopan/LNP023 in Participants With Primary IgA Nephropathy
Public ClinicalTrials.gov record NCT04557462. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Multicenter Rollover Extension Program (REP) to Evaluate the Long-term Safety and Tolerability of Open Label Iptacopan in Adult Participants With Primary IgA Nephropathy Who Have Completed Study CLNP023X2203 or CLNP023A2301
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04557462
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 448 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 100 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 19, 2021
- Primary completion
- Dec 3, 2030
- Completion
- Dec 3, 2030
- Last update posted
- Jul 29, 2026
2021 – 2030
United States locations
- U.S. sites
- 14
- U.S. states
- 13
- U.S. cities
- 14
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| AZ Kidney Dise and Hypertension Ctr | Glendale | Arizona | 85306 | — |
| Kaiser Permanente | San Diego | California | 92111 | — |
| North America Research Institute | San Dimas | California | 91773 | — |
| University of Colorado Anschutz | Aurora | Colorado | 80045 | — |
| CaRe Research | Chubbuck | Idaho | 83202 | — |
| Nep Assoc of Northern Illinois | Hinsdale | Illinois | 60521 | — |
| Johns Hopkins Hospital | Baltimore | Maryland | 21287 | — |
| Brigham and Womens Hosp Harvard Med School | Boston | Massachusetts | 02115 | — |
| Mayo Clinic Rochester | Rochester | Minnesota | 55905 | — |
| Clin Rsrch Consult a JCCT Company | Kansas City | Missouri | 64111 | — |
| DaVita Clinical Research | Las Vegas | Nevada | 89146 | — |
| New Jersey Kidney Care | Jersey City | New Jersey | 07305 | — |
| Col Uni Med Center New York Presby | New York | New York | 10032 | — |
| Dallas Renal Group | Dallas | Texas | 75230 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 141 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04557462, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 29, 2026 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04557462 live on ClinicalTrials.gov.