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RECRUITING Phase 3

Long-term Efficacy, Safety and Tolerability of Iptacopan in C3G or IC-MPGN

NCT03955445 · View on ClinicalTrials.gov ↗

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

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

FieldValue
Enrollment Target 225 participants
Start Date 2019-10-03
Est. Completion 2036-05-30
Phase Phase 3

Sponsor

Novartis Pharmaceuticals

792 total trials

Interested in This Trial?

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03955445

The ClinicalTrials.gov registry entry for NCT03955445 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 225 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 2 conditions, with C3 Glomerulopathy 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: NCT03955445 reports 20 study locations spanning 11 distinct geographic areas — top geographies include Other, São Paulo, Colorado. 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03955445?

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 NCT03955445?

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 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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial