Clinical trial Recruiting at 125 sites Phase 3 Interventional Ages 12 to 60

Evaluating iptacopan for treating idiopathic IC-MPGN

Official title: A Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled Study to Evaluate the Efficacy and Safety of Iptacopan (LNP023) in Idiopathic Immune-complex-mediated Membranoproliferative Glomerulonephritis (IC-MPGN)

Run by Novartis · NCT05755386 · Data updated 2026-11-12

This study is testing if a new medication called iptacopan can help people with a specific kidney condition called idiopathic IC-MPGN feel better by reducing protein in their urine and improving kidney function.

Quick facts

PhasePhase 3
Study typeInterventional
Ages12 Years to 60 Years
SexAll
Enrollment106 (estimated)
SponsorNovartis
Industry-sponsored
Drugs / interventionscyclophosphamide
Locations131 sites (Los Angeles, California and 130 other locations)
StatusRecruiting
StartedOctober 2, 2023
Main results expectedOctober 27, 2028
Study endsMay 31, 2029
Registry record updatedJuly 13, 2026
Trial IDNCT05755386 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include males and females aged 12-60 years diagnosed with idiopathic IC-MPGN confirmed by kidney biopsy.

Probably not a fit

Patients without a confirmed diagnosis of idiopathic IC-MPGN or those who have not been on recommended doses of RAS inhibitors may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase III study is a multicenter, randomized, double-blind, parallel group, placebo-controlled trial aimed at assessing the efficacy and safety of iptacopan (LNP023) in patients with idiopathic immune complex mediated membranoproliferative glomerulonephritis (IC-MPGN). Participants aged 12-60 years will receive either iptacopan or a placebo alongside standard care, with the primary focus on reducing proteinuria and improving estimated glomerular filtration rate (eGFR). The study will also evaluate changes in patient-reported fatigue. Following treatment, participants may enter a safety follow-up or continue with iptacopan in an open-label extension study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve kidney function and quality of life for patients with IC-MPGN.

How similar studies have gone: Other studies have shown promise with similar approaches targeting the alternative complement pathway, suggesting potential for success.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Male and female patients including adults (aged at least 18 years to ≤ 60 years) and adolescents (12 -17 years in non-EU countries at screening and 16-17 years in EU countries at screening).
* Diagnosis of idiopathic IC-MPGN as confirmed by kidney biopsy within 12 months prior to screening in adults and within 3 years of screening in adolescents (a biopsy report, review and confirmation by the Investigator is required). If such a biopsy is not available in an adult participant, this must be obtained at screening (performed and assessed locally for adults only).
* Prior to randomization, all participants must have been on a maximally recommended or tolerated dose of renin angiotensin system inhibitors (RASi), e.g an ACEi or ARB for at least 90 days (or as according to local guidelines). The doses of other drugs administered to reduce proteinuria and control the disease including mycophenolic acids (MPAs - mycophenolate mofetil or mycophenolate sodium), corticosteroids, SGLT2 inhibitors and mineralocorticoid receptor antagonists should be stable for at least 90 days prior to randomization
* UPCR ≥ 1.0 g/g (≥ 113 mg/mmol) sampled from the first morning void urine sample at Day -75 and Day -15
* Estimated GFR (using the chronic kidney disease \[CKD\]-EPI formula for adult participants and modified Schwartz formula for adolescents aged 12 to 17 years) or measured GFR ≥ 30 ml/min/1.73m2 at screening and Day -15.
* Mandatory vaccination against Neisseria meningitidis and Streptococcus pneumoniae infection prior to the start of study treatment. If the participant has not been previously vaccinated, or if a booster is required, the vaccine should be given according to local regulations at least 2 weeks prior to the first administration of study treatment. If the study treatment has to start earlier than 2 weeks post vaccination, prophylactic antibiotic treatment should be initiated in accordance with local standard of care.
* If not previously vaccinated, or if a booster is required, vaccination against Haemophilus influenzae infections should be given, if available and according to local regulations, at least 2 weeks prior to the first study treatment administration.

Exclusion Criteria:

* Participants who have undergone cell or solid organ transplantation, including kidney transplantation.
* Participants diagnosed with secondary IC-MPGN including but not limited to any of the following conditions:
* Deposition of antigen-antibody immune complexes as a result of any chronic infections, including

  * Hepatitis C virus (HCV) including HCV-associated mixed cryoglobulinemia, hepatitis B virus (HBV);
  * Bacterial-endocarditis, infected ventriculo-atrial shunt, visceral abscesses, leprosy, meningococcal meningitis; chronic bacterial infections
  * Protozoa/other infections- malaria, schistosomiasis, mycoplasma, leishmaniasis, filariasis, histroplasmosis

Renal deposition of immune complexes as a result of a systemic autoimmune disease:

* Systemic lupus erythematosus (SLE)
* Sjögren syndrome
* Rheumatoid arthritis
* Mixed connective tissue disease Deposition of monoclonal immunoglobulins because of a monoclonal gammopathy due to plasma cell or B cell disorders. Monoclonal gammopathy of undetermined significance (MGUS) confirmed by the measurement of serum free light chains or other investigation as per local standard of care.

Fibrillary glomerulonephritis

* Rapidly progressive crescentic glomerulonephritis defined as a 50% decline in the eGFR within 3 months with kidney biopsy findings of glomerular crescent formation seen in at least 50% of glomeruli on the most recent biopsy.
* Kidney biopsy showing interstitial fibrosis/tubular atrophy (IF/TA) of more than 50%.
* Participants with an active systemic bacterial, viral or fungal infection within 14 days prior to study treatment administration or the presence of fever ≥ 38°C (100.4°F) within 7 days prior to study treatment administration.
* A history of recurrent invasive infections caused by encapsulated organisms, e.g., Neisseria meningitidis and Streptococcus pneumoniae.
* The use of inhibitors of complement factors (e.g., Factor B, Factor D, complement 3 (C3) inhibitors, anti-Complement 5 (C5) antibodies, C5a receptor antagonists) within 3 months or 5 half-lives prior to the Screening visit.
* The use of immunosuppressants (except MPAs), cyclophosphamide or systemic corticosteroids at a dose \>7.5 mg/day (or equivalent for a similar corticosteroid medication) within 90 days of study drug administration.
* The use of MPAs is not permitted within 90 days prior to randomization in India, as per the local health authority requirement.
* Acute post-infectious glomerulonephritis at screening, based upon the opinion of the investigator.
* Body mass index (BMI) \>38 kg/m2 at screening and randomization. Body weight \<35 kg at screening and randomization

Where it's running

  • Ronald Reagan UCLA Medical Center
    Los Angeles, California, United States
    Recruiting
  • Univ Cali Irvine ALS Neuromuscular
    Orange, California, United States
    Recruiting
  • UCSF
    San Francisco, California, United States
    Recruiting
  • Olive View UCLA Medical Center
    Sylmar, California, United States
    Recruiting
  • Childrens Hospital Colorado
    Aurora, Colorado, United States
    Recruiting
  • Nicklaus Childrens Hospital
    Miami, Florida, United States
    Recruiting
Show 44 more locations
  • Emory University School of Medicine-Winship Cancer Institute
    Atlanta, Georgia, United States
    Recruiting
  • Massachusetts General Hospital
    Boston, Massachusetts, United States
    Recruiting
  • Boston Univ School of Medicine
    Boston, Massachusetts, United States
    Recruiting
  • University of Minnesota
    Minneapolis, Minnesota, United States
    Recruiting
  • Washington University in St Louis
    St Louis, Missouri, United States
    Recruiting
  • University of New Mexico
    Albuquerque, New Mexico, United States
    Recruiting
  • Col Uni Med Center New York Presby
    New York, New York, United States
    Recruiting
  • University Of Cincinnati
    Cincinnati, Ohio, United States
    Recruiting
  • OHSU Dept of Nephrology
    Portland, Oregon, United States
    Recruiting
  • Univ of Pennsylvania Medical Center
    Philadelphia, Pennsylvania, United States
    Recruiting
  • MUSC Health Lancaster Med Ctr
    Lancaster, South Carolina, United States
    Recruiting
  • UT Southwestern Medical Center
    Dallas, Texas, United States
    Recruiting
  • Prolato Clinical Research Center
    Houston, Texas, United States
    Recruiting
  • Baylor Scott and White Research
    Temple, Texas, United States
    Recruiting
  • University of Utah
    Salt Lake City, Utah, United States
    Recruiting
  • University of Wisconsin
    Madison, Wisconsin, United States
    Recruiting
  • Novartis Investigative Site
    Caba, Buenos Aires, Argentina
    Recruiting
  • Novartis Investigative Site
    Caba, Buenos Aires, Argentina
    Recruiting
  • Novartis Investigative Site
    Córdoba, Córdoba Province, Argentina
    Recruiting
  • Novartis Investigative Site
    Buenos Aires, Argentina
    Recruiting
  • Novartis Investigative Site
    Caba, Argentina
    Recruiting
  • Novartis Investigative Site
    Santa Fe, Argentina
    Recruiting
  • Novartis Investigative Site
    Fortaleza, Ceará, Brazil
    Recruiting
  • Novartis Investigative Site
    Belo Horizonte, Minas Gerais, Brazil
    Recruiting
  • Novartis Investigative Site
    Recife, Pernambuco, Brazil
    Recruiting
  • Novartis Investigative Site
    Natal, Rio Grande do Norte, Brazil
    Recruiting
  • Novartis Investigative Site
    Porto Alegre, Rio Grande do Sul, Brazil
    Recruiting
  • Novartis Investigative Site
    Botucatu, São Paulo, Brazil
    Recruiting
  • Novartis Investigative Site
    Santo André, São Paulo, Brazil
    Recruiting
  • Novartis Investigative Site
    Sao Jose Rio Preto, São Paulo, Brazil
    Recruiting
  • Novartis Investigative Site
    São Paulo, São Paulo, Brazil
    Recruiting
  • Novartis Investigative Site
    São Paulo, São Paulo, Brazil
    Recruiting
  • Novartis Investigative Site
    Salvador, Brazil
    Recruiting
  • Novartis Investigative Site
    Etobicoke, Ontario, Canada
    Recruiting
  • Novartis Investigative Site
    London, Ontario, Canada
    Recruiting
  • Novartis Investigative Site
    Toronto, Ontario, Canada
    Recruiting
  • Novartis Investigative Site
    Montreal, Quebec, Canada
    Recruiting
  • Novartis Investigative Site
    Montreal, Quebec, Canada
    Recruiting
  • Novartis Investigative Site
    Prague, Czechia
    Recruiting
  • Novartis Investigative Site
    Aarhus N, Denmark
    Recruiting
  • Novartis Investigative Site
    Copenhagen, Denmark
    Recruiting
  • Novartis Investigative Site
    Marseille, France
    Recruiting
  • Novartis Investigative Site
    Montpellier, France
    Recruiting
  • Novartis Investigative Site
    Paris, France
    Recruiting

+81 more sites. See ClinicalTrials.gov for the full list.

Study contacts

Similar studies

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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.
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Last reviewed 2026-11-14 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.