At a glance
ClinicalIndex Comparison Record- ✓Age 12-60 years at screening
- ✓C3G confirmed by renal biopsy within 12 months (adults) or 3 years (adolescents) prior to enrollment
- ✓On maximally recommended or tolerated dose of ACEI or ARB for at least 90 days prior to randomization
- ✓Stable antiproteinuric medications (mycophenolic acid, corticosteroids, mineralocorticoid receptor antagonists) for at least 90 days prior to randomization
- ✕Prior cell or organ transplantation, including kidney transplantation
- ✕Rapidly progressive crescentic glomerulonephritis with 50% eGFR decline within 3 months and glomerular crescent formation in ≥50% of glomeruli
- ✕Interstitial fibrosis/tubular atrophy (IF/TA) >50% on renal biopsy
- ✕Monoclonal gammopathy of undetermined significance (MGUS) confirmed by serum free light chains or other investigation
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled Study to Evaluate the Efficacy and Safety of Iptacopan (LNP023) in Complement 3 Glomerulopathy.
In Brief
A Phase 3 clinical trial evaluating Placebo and iptacopan for C3G. Currently recruiting, targeting 98 participants across 87 sites in 19 countries.
Detailed 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.
Study Details
Timeline
Arms & Interventions
iptacopan 200 mg b.i.d.
Placebo to iptacopan 200mg b.i.d.
Interventions
Placebo to iptacopan 200mg b.i.d. (Adults 200mg b.i.d; Adolescents 2x 100mg b.i.d)
iptacopan 200 mg b.i.d. (Adults 200mg b.i.d; Adolescents 2x 100mg b.i.d)