A Rollover Extension Program (REP) to Evaluate the Long-term Safety and Tolerability of Open Label Iptacopan/LNP023 in Participants With Primary IgA Nephropathy

Running, not enrolling · Phase 3

Conditions studied: Primary IgA Nephropathy

In brief

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.

Key facts

Study ID

NCT04557462

Run by

Novartis Pharmaceuticals

People needed

448

Starts

2021-09-20

Expected to finish

2030-12-04

Last updated by the study team

2026-07-30

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 is running

• Kaiser Permanente — San Diego, California, United States
• North America Research Institute — San Dimas, California, United States
• University of Colorado Anschutz — Aurora, Colorado, United States
• CaRe Research — Chubbuck, Idaho, United States
• Nep Assoc of Northern Illinois — Hinsdale, Illinois, United States
• Johns Hopkins Hospital — Baltimore, Maryland, United States
• Brigham and Womens Hosp Harvard Med School — Boston, Massachusetts, United States
• Mayo Clinic Rochester — Rochester, Minnesota, United States
• Clin Rsrch Consult a JCCT Company — Kansas City, Missouri, United States
• DaVita Clinical Research — Las Vegas, Nevada, United States
• New Jersey Kidney Care — Jersey City, New Jersey, United States
• Col Uni Med Center New York Presby — New York, New York, United States
• Dallas Renal Group — Dallas, Texas, United States
• Novartis Investigative Site — Córdoba, Córdoba Province, Argentina
• Novartis Investigative Site — Córdoba, Córdoba Province, Argentina
• Novartis Investigative Site — CABA, Argentina
• Novartis Investigative Site — CABA, Argentina
• Novartis Investigative Site — Santa Fe, Argentina
• Novartis Investigative Site — Woolloongabba, Queensland, Australia
• Novartis Investigative Site — Adelaide, South Australia, Australia
• Novartis Investigative Site — Parkville, Victoria, Australia
• Novartis Investigative Site — Roeselare, West-Vlaanderen, Belgium
• Novartis Investigative Site — Edegem, Belgium
• Novartis Investigative Site — Leuven, Belgium
• AZ Kidney Dise and Hypertension Ctr — Glendale, Arizona, United States

Full record on ClinicalTrials.gov

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