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Long-term treatment with iptacopan for C3 glomerulopathy and IC-MPGN

An Open-label, Non-randomized Extension Study to Evaluate the Long-term Efficacy, Safety and Tolerability of Iptacopan (LNP023) in C3 Glomerulopathy or Idiopathic Immune-complex-membranoproliferative Glomerulonephritis

PHASE3 · Novartis · NCT03955445

This study is testing if the medication iptacopan can safely help people with C3 glomerulopathy or immune-complex-membranoproliferative glomerulonephritis over a longer period of time.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment225 (estimated)
Ages12 Years to 100 Years
SexAll
SponsorNovartis (industry)
Locations50 sites (Aurora, Colorado and 49 other locations)
Trial IDNCT03955445 on ClinicalTrials.gov

What this trial studies

This open-label extension study evaluates the long-term efficacy, safety, and tolerability of iptacopan in patients with C3 glomerulopathy or idiopathic immune-complex-membranoproliferative glomerulonephritis. Participants who have completed prior studies will receive iptacopan, allowing researchers to gather additional data on its effects beyond the initial treatment period. The study aims to support health authority submissions by providing comprehensive efficacy and safety information over an extended duration. It includes both adults and adolescents from ongoing Phase 3 programs.

Who should consider this trial

Good fit: Ideal candidates are patients who have completed prior studies involving iptacopan and meet specific eligibility criteria.

Not a fit: Patients with severe concurrent co-morbidities or active infections may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve outcomes for patients with C3 glomerulopathy and IC-MPGN.

How similar studies have performed: Other studies have shown promising results with iptacopan, indicating potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

\- Patients must have completed the treatment period of the CLNP023X2202, CLNP023B12301 or CLNP023B12302 study on study drug

Exclusion Criteria:

* Severe concurrent co-morbidities, e.g. advanced cardiac disease (NYHA class IV), severe pulmonary arterial hypertension (WHO class IV), or any illness or medical condition that in the opinion of the investigator and sponsor is likely to prevent the patient from safely tolerating LNP023 or complying with the requirements of the study
* Participants with an active systemic bacterial, viral or fungal infection within 14 days prior to screening, or the presence of fever ≥ 38oC (100.4oF) within 7 days prior to screening.
* History or current diagnosis of ECG abnormalities indicating significant risk of safety for subjects
* History of HIV or any other immunodeficiency disease

Other protocol-defined inclusion/exclusion criteria may apply

Where this trial is running

Aurora, Colorado and 49 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: C3 Glomerulopathy, Immune-complex-membranoproliferative Glomerulonephritis, C3G, C3 glomerulopathy, C3GN, C3 glomerulonephritis, DDD, dense deposit disease

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.