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Clinical Trials in India / NCT04817618
Recruiting Phase 3

Study of Efficacy and Safety of Iptacopan in Patients With C3 Glomerulopathy.

NCT04817618 · tracked via the Priya Life Science India tracker
Sponsor
Novartis Pharmaceuticals
Phase
Phase 3
Started
2021-07-28
Last updated
2026-07-13

Condition(s) studied

C3G

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

The Primary Completion Date and Study Completion Date have been updated to reflect completion of the adolescent cohort, which has been added to the protocol.

The study is designed as a multicenter, randomized, double-blind, parallel group, placebo-controlled study to evaluate the efficacy and safety of iptacopan (LNP023) in complement 3 glomerulopathy.

Eligibility

Sex
ALL
Min age
12 Years
Max age
60 Years
Healthy volunteers
No
Inclusion Criteria: * Male and female participants age ≥ 12 and ≤ 60 years at screening. * Diagnosis of C3G as confirmed by renal biopsy within 12 months prior to enrollment in adults and within 3 years in adolescents. * Prior to randomization, all participants must have been on a maximally recommended or tolerated dose of an angiotensin converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB) for at least 90 days. The doses of other antiproteinuric medications including mycophenolic acid, corticosteroids and mineralocorticoid receptor antagonists should be stable for at least 90 days prior to randomization. * Reduced serum C3 (defined as less than 0.85 x lower limit of the central laboratory normal range) at Screening. * UPCR ≥ 1.0 g/g sampled from the first morning void urine sample at Day -75 and Day -15. * Estimated GFR (using the CKD-EPI formula for ages ≥ 18 years and modified Schwartz formula for ages 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 prior to the start of study treatment. * 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. If study treatment has to start earlier than 2 weeks post vaccination, prophylactic antibiotic treatment should be initiated. Exclusion Criteria: * Participants who have received any cell or organ transplantation, including a kidney transplantation. * Rapidly progressive crescentic glomerulonephritis defined as a 50% decline in the eGFR within 3 months with renal biopsy findings of glomerular crescent formation seen in at least 50% of glomeruli. * Renal biopsy showing interstitial fibrosis/tubular atrophy (IF/TA) of more than 50% * Monoclonal gammopathy of undetermined significance (MGUS) confirmed by the measurement of serum free light chains or other investigation as per local standard of care. * Participants with an active systemic bacterial, viral or fungal infection within 14 days prior to study treatment administration * 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., N. meningitidis and S. pneumoniae. * The use of inhibitors of complement factors (e.g., Factor B, Factor D, C3 inhibitors, anti C5 antibodies, C5a receptor antagonists) within 6 months prior to the Screening visit. * The use of immunosuppressants (except mycophenolic acids), cyclophosphamide or systemic corticosteroids at a dose \>7.5 mg/day (or equivalent for a similar medication) within 90 days of study drug administration. * Acute post-infectious glomerulonephritis at screening based upon the opinion of the investigator.

Primary outcome measure(s)

Trial sites (87)

FacilityCityRegionStatus
Childrens Hospital Colorado Aurora Colorado Recruiting
Nicklaus Childrens Hospital Miami Florida Recruiting
Georgia Nephrology Research Inst Lawrenceville Georgia Completed
IN University School of Med Indianapolis Indiana Withdrawn
University of Iowa Health Care Iowa City Iowa Recruiting
University of Iowa Health Care Iowa City Iowa Recruiting
Johns Hopkins Hospital Baltimore Maryland Withdrawn
Brigham and Womens Hosp Harvard Med School Boston Massachusetts Withdrawn
Hackensack Uni Medical Center Hackensack New Jersey Withdrawn
Albany Medical Center Albany New York Withdrawn
Col Uni Med Center New York Presby New York New York Completed
Baylor Scott and White Research Temple Texas Withdrawn
University of Wisconsin Madison Wisconsin Recruiting
Novartis Investigative Site Córdoba Córdoba Province Withdrawn
Novartis Investigative Site Buenos Aires Argentina Completed
Novartis Investigative Site CABA Argentina Withdrawn
Novartis Investigative Site Edegem Belgium Withdrawn
Novartis Investigative Site Leuven Belgium Withdrawn
Novartis Investigative Site Belo Horizonte Minas Gerais Active Not Recruiting
Novartis Investigative Site Recife Pernambuco Recruiting
Novartis Investigative Site Passo Fundo Rio Grande do Sul Recruiting
Novartis Investigative Site Joinville Santa Catarina Withdrawn
Novartis Investigative Site Santo André São Paulo Withdrawn
Novartis Investigative Site São Paulo São Paulo Recruiting
Novartis Investigative Site São Paulo São Paulo Withdrawn
Novartis Investigative Site Salvador Brazil Recruiting
Novartis Investigative Site London Ontario Completed
Novartis Investigative Site Toronto Ontario Completed
Novartis Investigative Site Montreal Quebec Withdrawn
Novartis Investigative Site Guangzhou Guangdong Active Not Recruiting
Novartis Investigative Site Wuhan Hubei Withdrawn
Novartis Investigative Site Beijing China Active Not Recruiting
Novartis Investigative Site Beijing China Recruiting
Novartis Investigative Site Shanghai China Active Not Recruiting
Novartis Investigative Site Prague Czechia Completed
Novartis Investigative Site Lille France Completed
Novartis Investigative Site Marseille France Withdrawn
Novartis Investigative Site Montpellier France Withdrawn
Novartis Investigative Site Paris France Completed
Novartis Investigative Site Paris France Withdrawn

+ 47 more sites — see the full list on the official registry below.

More Novartis Pharmaceuticals trials in India

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 NCT04817618 on ClinicalTrials.gov ↗ ← All trials in India