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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.

Key facts

Who runs it
Novartis Pharmaceuticals
Where
Groningen, NetherlandsSee the siteAlso in 35 other countries, 133 sites
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
Status
Recruiting
Phase
Phase 3
People taking part
540 people, planned
Started
20 Sept 2021
Expected to end
4 Dec 2030
Type of study
Interventional
Treatments tested
  • LNP023
Record updated
5 October 2026

Who can take part

AI summary

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

The registry criteria, word for word

Show all 12 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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

Check if you might fit

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?

Where in Netherlands

Also in 35 other countries, 133 sites

  • Universitair Medisch Centrum GroningenGroningen, NetherlandsNo longer taking part

About the trial

What the trial wants to find out

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.

The group in the trial

  • LNP023Treatment being tested

    All participants are receiving 200 mg b.i.d

Questions to ask the study team

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

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

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
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
Plain-language title
Long-term safety of iptacopan in people with primary IgA nephropathyGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT04557462, who can take part
Publications
Record updated
5 October 2026