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
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 12 Years to 60 Years |
| Sex | All |
| Enrollment | 106 (estimated) |
| Sponsor | Novartis Industry-sponsored |
| Drugs / interventions | cyclophosphamide |
| Locations | 131 sites (Los Angeles, California and 130 other locations) |
| Status | Recruiting |
| Started | October 2, 2023 |
| Main results expected | October 27, 2028 |
| Study ends | May 31, 2029 |
| Registry record updated | July 13, 2026 |
| Trial ID | NCT05755386 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
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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
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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
- Study coordinator: Novartis Pharmaceuticals
- Email: novartis.email@novartis.com
- Phone: 1-888-669-6682
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ADX-038 with or without telitacicept for Chinese adults with IgA nephropathy, C3G, or IC-MPGN
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.