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

A Multicenter Rollover Extension Program (REP) to Evaluate the Long-term Safety and Tolerability of Open Label Iptacopan in Adult Participants With Primary IgA Nephropathy Who Have Completed Study CLNP023X2203 or CLNP023A2301

Phase 3 Interventional Novartis · NCT04557462

This study is testing the long-term safety of a drug called iptacopan for people with primary IgA nephropathy who have already participated in earlier trials.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment540 (estimated)
Ages18 Years to 100 Years
SexAll
SponsorNovartis Industry-sponsored
Drugs / interventionsrituximab, infliximab, eculizumab, canakinumab, cyclophosphamide, prednisone
Locations161 sites (Glendale, Arizona and 160 other locations)
Trial IDNCT04557462 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates for this study are individuals who have completed prior trials involving iptacopan and meet specific eligibility criteria related to kidney function.

Not a fit: Patients who have not participated in the previous iptacopan trials or those with severely impaired kidney function may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide patients with a continuous treatment option that may improve long-term outcomes in primary IgA nephropathy.

How similar studies have performed: Other studies involving iptacopan have shown promising results, indicating that this approach may be effective in treating primary IgA nephropathy.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 this trial is running

Glendale, Arizona and 160 other locations

+111 more sites — see ClinicalTrials.gov for the full list.

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 → Find more trials like this →
Conditions Primary IgA NephropathyImmunoglobulin A nephropathyPrimary IgA nephropathyIgANchronic kidney diseaseglomerulonephritiscomplement alternative pathwayeGFR
Last reviewed 2026-06-13 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.