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Clinical Trials in the UK / NCT05755386
Recruiting Phase 3

Study of Efficacy and Safety of Iptacopan in Participants With IC-MPGN

NCT05755386 · tracked via the Priya Life Science UK tracker
Sponsor
Novartis Pharmaceuticals
Phase
Phase 3
Started
2023-10-02
Last updated
2026-07-13

Condition(s) studied

IC-MPGN

Investigational drug(s) / intervention(s)

Placeboiptacopan

Placebo: Placebo to iptacopan 200mg b.i.d. (Adults 200mg b.i.d; Adolescents 2x 100mg b.i.d)

iptacopan: iptacopan 200 mg b.i.d. (Adults 200mg b.i.d; Adolescents 2x 100mg b.i.d)

Study summary

This study is designed as 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.

Eligibility

Sex
ALL
Min age
12 Years
Max age
60 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (131)

FacilityCityRegionStatus
Ronald Reagan UCLA Medical Center Los Angeles California Recruiting
Univ Cali Irvine ALS Neuromuscular Orange California Recruiting
UCSF San Francisco California Recruiting
Olive View UCLA Medical Center Sylmar California Recruiting
Childrens Hospital Colorado Aurora Colorado Recruiting
Nicklaus Childrens Hospital Miami Florida Recruiting
Emory University School of Medicine-Winship Cancer Institute Atlanta Georgia Recruiting
Massachusetts General Hospital Boston Massachusetts Recruiting
Boston Univ School of Medicine Boston Massachusetts Recruiting
University of Minnesota Minneapolis Minnesota Recruiting
Washington University in St Louis St Louis Missouri Recruiting
University of New Mexico Albuquerque New Mexico Recruiting
Col Uni Med Center New York Presby New York New York Recruiting
University Of Cincinnati Cincinnati Ohio Recruiting
OHSU Dept of Nephrology Portland Oregon Recruiting
Univ of Pennsylvania Medical Center Philadelphia Pennsylvania Recruiting
MUSC Health Lancaster Med Ctr Lancaster South Carolina Recruiting
UT Southwestern Medical Center Dallas Texas Recruiting
Prolato Clinical Research Center Houston Texas Recruiting
Baylor Scott and White Research Temple Texas Recruiting
University of Utah Salt Lake City Utah Recruiting
University of Wisconsin Madison Wisconsin Recruiting
Novartis Investigative Site CABA Buenos Aires Recruiting
Novartis Investigative Site CABA Buenos Aires Recruiting
Novartis Investigative Site Córdoba Córdoba Province 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 Recruiting
Novartis Investigative Site Brasília Federal District Withdrawn
Novartis Investigative Site Belo Horizonte Minas Gerais Recruiting
Novartis Investigative Site Recife Pernambuco Recruiting
Novartis Investigative Site Niterói Rio de Janeiro Withdrawn
Novartis Investigative Site Rio de Janeiro Rio de Janeiro Withdrawn
Novartis Investigative Site Natal Rio Grande do Norte Recruiting
Novartis Investigative Site Porto Alegre Rio Grande do Sul Recruiting
Novartis Investigative Site Botucatu São Paulo Recruiting
Novartis Investigative Site Santo André São Paulo Recruiting
Novartis Investigative Site Sao Jose Rio Preto São Paulo Recruiting
Novartis Investigative Site São Paulo São Paulo Recruiting

+ 91 more sites — see the full list on the official registry below.

More Novartis Pharmaceuticals trials in the UK

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05755386 on ClinicalTrials.gov ↗ ← All trials in the UK