Taking peoplePhase 3

Long-term safety of iptacopan in people with primary IgA nephropathy

Tests iptacopan's long-term safety in adults with primary IgA nephropathy, a kidney disease.

Plain-language title generated from the registry record
Registry title: A Rollover Extension Program (REP) to Evaluate the Long-term Safety and Tolerability of Open Label Iptacopan/LNP023 in Participants With Primary IgA Nephropathy

Key facts

Where: Oshawa, CanadaSee the site
Phase: Phase 3

AI summary: who the study is looking for

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with primary IgA nephropathy who finished the earlier iptacopan trial CLNP023X2203 or CLNP023A2301. They get open-label iptacopan for long-term safety follow-up.

Age: 18 to 100 years
Sex: All sexes can join.
Disease stage: Primary IgA nephropathy, with eGFR of 20 ml/min/1.73m2 or higher. Rapidly progressive glomerulonephritis (50% fall in eGFR within the last 3 months) is not allowed.
Earlier treatment: Must have completed part 1 or part 2 of CLNP023X2203, or the full 24 month treatment period of CLNP023A2301. Vaccines against Neisseria meningitidis, Streptococcus pneumoniae and Haemophilus influenzae must be up to date. Must be on an ACEi or ARB, unless allergic or intolerant. No immunosuppressive drugs within the washout time set in the record (rituximab needs 180 days).
Biomarker or test result: eGFR of 20 ml/min/1.73m2 or higher.

Main reasons for not taking part

Failed screening or baseline, or left the earlier trial early for any reason
Severe urinary obstruction or another urinary tract disorder besides IgAN
Acute kidney injury within 4 weeks before the first dose
History of repeated serious infections with encapsulated bacteria such as meningococcus and pneumococcus
Other investigational drugs at enrolment or within 30 days

Read by machine on 9 November 2026.

Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

Are you between 18 and 100 years old?

Source: NCT04557462, who can take part

Where in Canada

Oshawa, OntarioHospital not named in the registryContact: Novartis PharmaceuticalsNo longer taking part

Questions to ask the study team

How often do I need to come in, and for how long each time?
Are travel costs paid?
Can I keep my own doctor?
What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Trial details

Who runs it: Novartis Pharmaceuticals
Trial code: NCT04557462 EU 2023-508690-92-00
Record updated: 5 October 2026
Original description: The purpose of this study is to evaluate the long-term safety and tolerability, of open label iptacopan in primary IgA nephropathy participants who have completed either the CLNP023X2203 or CLNP023A2301 clinical trials. The open-label design of the current study is appropriate to provide study participants the opportunity to receive treatment with iptacopan until marketing authorizations are received and the drug product becomes commercially available while enabling collection of long-term safety and tolerability data for the investigational drug. Furthermore efficacy assessments conducted every 6 months will afford the opportunity to evaluate the clinical effects of iptacopan on long-term disease progression.Read full original descriptionShow less
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
The purpose of this study is to evaluate the long-term safety and tolerability, of open label iptacopan in primary IgA nephropathy participants who have completed either the CLNP023X2203 or CLNP023A2301 clinical trials. The open-label design of the current study is appropriate to provide study participants the opportunity to receive treatment with iptacopan until marketing authorizations are received and the drug product becomes commercially available while enabling collection of long-term safety and tolerability data for the investigational drug. Furthermore efficacy assessments conducted every 6 months will afford the opportunity to evaluate the clinical effects of iptacopan on long-term disease progression.
Inclusion: 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: Current (within 4 weeks of study drug administration in the REP) acute kidney injury (AKI); Use of other investigational drugs at the time of enrolment, or within 5 half-lives of enrolment or within 30 days whichever is longer; Evidence of severe urinary obstruction or difficulty in voiding; any urinary tract disorder other than IgAN at screening and before dosing with LNP023; History of recurrent invasive infections caused by encapsulated organisms, such as meningococcus and pneumococcus; 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; 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.
ClinicalTrials.gov NCT04557462 · EU CTIS 2023-508690-92-00