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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Childrens Hospital Colorado
  Aurora, Colorado, United States Recruiting
• Georgia Nephrology Research Inst
  Lawrenceville, Georgia, United States Recruiting
• University of Iowa Health Care
  Iowa City, Iowa, United States Recruiting
• University of Minnesota
  Minneapolis, Minnesota, United States Recruiting
• Col Uni Med Center New York Presby
  New York, New York, United States Recruiting
• Novartis Investigative Site
  Caba, Buenos Aires, Argentina Recruiting

+3 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Novartis Pharmaceuticals
• Email: novartis.email@novartis.com
• Phone: 1-888-669-6682

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Iptacopan use in Korean patients with PNH or C3G

  This post-marketing surveillance study tests how well iptacopan works and how safe it is for Korean adults with PNH or C3G in real-world care.

  Recruiting at 3 sites Novartis · Jeollanam and 2 other locations · NCT07416162

• Home-reported outcomes for people with C3 Glomerulopathy

  This project will collect monthly home-reported symptoms, treatment use, and quality-of-life information from adults with C3 glomerulopathy and their caregivers to see how these change over time.

  Recruiting Novartis · East Hanover, New Jersey · NCT07029542

• National Registry for Rare Kidney Diseases

  This study is collecting health information from people with rare kidney diseases to help improve treatments and create better care guidelines.

  Recruiting UK Kidney Association · Bristol, South West · NCT06065852

• Comparing Aliskiren and Enalapril for C3 Glomerulopathy Treatment

  This study is testing whether a new kidney treatment called aliskiren works better than the standard treatment enalapril for people with C3 glomerulopathy.

  Recruiting Phase 2 Region Skane · Gothenburg and 3 other locations · NCT04183101

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.