Long-term safety evaluation of iptacopan for patients with primary IgA nephropathy

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 clinical trial is designed as a rollover extension program to assess the long-term safety and tolerability of iptacopan in participants who have previously completed related clinical trials for primary IgA nephropathy. The open-label format allows participants to continue receiving treatment while collecting valuable data on the drug's effects over time. Efficacy assessments will be conducted every six months to monitor the clinical impact of iptacopan on disease progression. The study aims to provide ongoing treatment until the drug becomes commercially available or until certain clinical criteria are met.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* For LNP023X2203, participants must have completed part 1 or part 2 of the trial. For LNP023A2301, participants must have completed the entire core trial defined as the full 24 month treatment period.
* eGFR\* ≥ 20 ml/min/1.73m2

  \*eGFR calculated using the CKD-EPI formula (or modified MDRD formula according to specific ethnic groups and local practice guidelines)
* Per investigator's clinical judgement, the participant may benefit from receiving the open-label treatment of iptacopan 200 mg b.i.d.
* Prior Vaccination against Neisseria meningitidis, Streptococcus pneumoniae and Haemophilus influenzae infections should be up to date (i.e. any boosters required administered according to local regulations.
* All participants must be on supportive care regimen of ACEi or ARB\* as per KDIGO guidelines.

  * participants who are not taking KDIGO guideline doses because they have documented allergies or intolerance to ACEi and ARB are eligible for the study

Exclusion Criteria:

* participants who screen or baseline failed in the CLNP023X2203 Part 1 or Part 2, or CLNP023A2301 studies or who prematurely withdrew from either study for any reason.
* Evidence of severe urinary obstruction or difficulty in voiding; any urinary tract disorder other than IgAN at screening and before dosing with LNP023.
* Current (within 4 weeks of study drug administration in the REP) acute kidney injury (AKI)
* Presence of Rapidly Progressive Glomerulonephritis (RPGN) as defined by 50% decline in eGFR within the last 3 months.
* Participants treated with immunosuppressive or other immunmodulatory agents such as but not limited to cyclophosphamide, rituximab, infliximab, eculizumab, canakinumab, mycophenolate mofetil (MMF) or mycophenolate sodium (MPS), cyclosporine, tacrolimus, sirolimus, everolimus and/or systemic corticosteroids exposure (\>7.5 mg/d prednisone/prednisolone equivalent) within 5 half-lives of respective medication or 90 days prior to first study drug administration, whichever is shorter. Rituximab requires 180 days wash out.
* Use of other investigational drugs at the time of enrolment, or within 5 half-lives of enrolment or within 30 days whichever is longer.
* History of recurrent invasive infections caused by encapsulated organisms, such as meningococcus and pneumococcus.

Where it's running

• Col Uni Med Center New York Presby
  New York, New York, United States Recruiting
• AZ Kidney Dise and Hypertension Ctr
  Glendale, Arizona, United States Active not recruiting
• Kaiser Permanente
  San Diego, California, United States Active not recruiting
• North America Research Institute
  San Dimas, California, United States Active not recruiting
• University of Colorado Anschutz
  Aurora, Colorado, United States Active not recruiting
• Nephrology Associates PA
  Newark, Delaware, United States Withdrawn

+111 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.

• Long-term safety and tolerability of HRS-5965 in primary IgA nephropathy

  This study tests whether HRS-5965 capsules are safe to use over the long term and whether they can reduce 24-hour urinary protein and slow eGFR decline in adults with primary IgA nephropathy who previously completed or stopped during maintenance.

  Recruiting Phase 2 Chengdu Suncadia Medicine Co., Ltd. · Beijing, Beijing Municipality · NCT07582133

• YKST02 for adults with primary IgA nephropathy.

  This trial will test whether intravenous YKST02 is safe and can reduce urine protein in adults with primary IgA nephropathy who have persistent proteinuria despite standard treatment.

  Recruiting Early Phase 1 Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Wuhan, Hubei · NCT07498673

• SHR-2173 for people with primary IgA nephropathy

  This trial will test whether SHR-2173 injections can reduce proteinuria and protect kidney function in adults with primary IgA nephropathy compared with placebo over 48 weeks.

  Recruiting at 2 sites Phase 2 Guangdong Hengrui Pharmaceutical Co., Ltd · Guangzhou, Guangdong and 1 other locations · NCT07354932

• Tonsil removal plus immunosuppression for high-risk IgA nephropathy in Caucasian adults

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• HRS-5965 capsule for primary IgA nephropathy

  This Phase 3 trial will test whether HRS-5965 capsules reduce proteinuria and are safe for people with biopsy-confirmed primary IgA nephropathy who have persistent proteinuria and eGFR ≥30.

  Recruiting Phase 3 Chengdu Suncadia Medicine Co., Ltd. · Beijing, Beijing Municipality · NCT07014826

• JADE101 in IgA Nephropathy: a Phase 2 test in adults

  This Phase 2 open-label study tests JADE101 in adults with IgA nephropathy to see how safe it is and how well it works when added to standard care.

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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.