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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 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.

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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

Conditions Studied

C3 Glomerulopathy 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

1,375 total trials

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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, categorized as Phase 3. The registered enrollment target is 225 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 71-participant average among 3 other C3 Glomerulopathy trials with a reported enrollment target (217% higher). The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 11 distinct geographic areas - top geographies include 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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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.