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NCT03955445 · ClinicalTrials.gov registry record · Phase 3
Long-term Efficacy, Safety and Tolerability of Iptacopan in C3G or IC-MPGN
A Phase 3 study of C3 Glomerulopathy and Immune-complex-membranoproliferative Glomerulonephritis, sponsored by Novartis Pharmaceuticals.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 225
- Enrollment target
- 20
- Study locations
NCT03955445: Recruiting Phase 3 study of C3 Glomerulopathy and Immune-complex-membranoproliferative Glomerulonephritis, sponsored by Novartis Pharmaceuticals.
NCT03955445 is a Phase 3 study of C3 Glomerulopathy and Immune-complex-membranoproliferative Glomerulonephritis that is actively recruiting participants, run by Novartis Pharmaceuticals. The registered enrollment target is 225 participants, above the 71-participant average among 3 other C3 Glomerulopathy trials with a reported enrollment target (217% higher). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03955445, a Phase 3 study of C3 Glomerulopathy and Immune-complex-membranoproliferative Glomerulonephritis, is actively recruiting participants, sponsored by Novartis Pharmaceuticals.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 225 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is an open-label extension study to evaluate the long-term efficacy, safety and tolerability of iptacopan in subjects with C3 glomerulopathy or idiopathic immune-complex-membranoproliferative glomerulonephritis
Primary Outcome
A participant meets the requirements of the composite renal endpoint if they satisfy the following criteria at the 9-month visit in CLNP023B12001B: (1) a stable or improved eGFR compared to the baseline visit in CLNP023X2202 (≤10% reduction in eGFR), and (2) either ≥50% reduction compared to the baseline visit in CLNP023X2202 or a reduction to \<300 mg/g in UPCR and (3) either a ≥50% increase in C3 compared to baseline or an increase to ≥90 mg/dL (i.e., ≥ the lower limit of normal (LLN)). Initia
Conditions Studied
Interventions
- DRUG LNP023
Study Locations (20)
Other
- Novartis Investigative Site - Buenos Aires
- Novartis Investigative Site - Salvador
- Novartis Investigative Site - Beijing
- Novartis Investigative Site - Shanghai
- Novartis Investigative Site - Prague
- Novartis Investigative Site - Montpellier
- Novartis Investigative Site - Paris
- Novartis Investigative Site - Toulouse
- Novartis Investigative Site - Erlangen
São Paulo
- Novartis Investigative Site - Botucatu
- Novartis Investigative Site - São Paulo
Colorado
- Childrens Hospital Colorado - Aurora
Georgia
- Georgia Nephrology Research Inst - Lawrenceville
Iowa
- University of Iowa Health Care - Iowa City
Minnesota
- University of Minnesota - Minneapolis
New York
- Col Uni Med Center New York Presby - New York
Buenos Aires
- Novartis Investigative Site - CABA
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 225 participants |
| Start Date | 2019-10-03 |
| Est. Completion | 2036-05-30 |
| Phase | Phase 3 |
What NCT03955445 shows while recruiting
NCT03955445 is an interventional study that assigns participants to a tested intervention. The registered 225 participants enrollment target is mid-sized for trials with a published cap, above the 71-participant average among 3 other C3 Glomerulopathy trials with a reported enrollment target (217% higher).
The record links to 2 conditions, with C3 Glomerulopathy appearing as the primary indexed condition, and to 1 intervention - of which LNP023 is the first listed.
NCT03955445 names 20 study sites across 11 states, led by Other, São Paulo, Colorado.
Frequently Asked Questions
What is clinical trial NCT03955445 about?
NCT03955445 is a clinical study titled "Long-term Efficacy, Safety and Tolerability of Iptacopan in C3G or IC-MPGN". This is an open-label extension study to evaluate the long-term efficacy, safety and tolerability of iptacopan in subjects with C3 glomerulopathy or idiopathic immune-complex-membranoproliferative glomerulonephritis
What is the current status of trial NCT03955445?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 225 participants. The study started on 2019-10-03. Estimated completion is 2036-05-30.
What conditions does trial NCT03955445 study?
This clinical trial studies the following conditions: C3 Glomerulopathy, Immune-complex-membranoproliferative Glomerulonephritis.
What interventions are being tested in trial NCT03955445?
The interventions under investigation include: LNP023 (DRUG).
Who is sponsoring clinical trial NCT03955445?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03955445 being conducted?
This trial has 20 study locations across Colorado, Georgia, Iowa, Minnesota, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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