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

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: C3G

In brief

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.

Key facts

Study ID

NCT04817618

Run by

Novartis Pharmaceuticals

People needed

98

Starts

2021-07-28

Expected to finish

2027-01-29

Last updated by the study team

2026-07-13

Who can join

Age: 12 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Novartis Investigative Site — Salvador, Brazil (enrolling)
• Nicklaus Childrens Hospital — Miami, Florida, United States (enrolling)
• Novartis Investigative Site — Recife, Pernambuco, Brazil (enrolling)
• University of Iowa Health Care — Iowa City, Iowa, United States (enrolling)
• Childrens Hospital Colorado — Aurora, Colorado, United States (enrolling)
• University of Wisconsin — Madison, Wisconsin, United States (enrolling)
• Novartis Investigative Site — Beijing, China (enrolling)
• Novartis Investigative Site — Passo Fundo, Rio Grande do Sul, Brazil (enrolling)
• University of Iowa Health Care — Iowa City, Iowa, United States (enrolling)
• Novartis Investigative Site — São Paulo, São Paulo, Brazil (enrolling)
• Novartis Investigative Site — Córdoba, Córdoba Province, Argentina
• Novartis Investigative Site — São Paulo, São Paulo, Brazil
• Baylor Scott and White Research — Temple, Texas, United States
• Novartis Investigative Site — Buenos Aires, Argentina
• Johns Hopkins Hospital — Baltimore, Maryland, United States
• Col Uni Med Center New York Presby — New York, New York, United States
• Albany Medical Center — Albany, New York, United States
• Novartis Investigative Site — Belo Horizonte, Minas Gerais, Brazil
• Novartis Investigative Site — Leuven, Belgium
• Hackensack Uni Medical Center — Hackensack, New Jersey, United States
• Novartis Investigative Site — Joinville, Santa Catarina, Brazil
• Novartis Investigative Site — Santo André, São Paulo, Brazil
• Novartis Investigative Site — Edegem, Belgium
• Novartis Investigative Site — CABA, Argentina
• Brigham and Womens Hosp Harvard Med School — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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