CI

At a glance

ClinicalIndex Comparison Record
Phase 3Recruiting· 106 target
Drug / intervention
Placebo +1 moredrug
Likely dose
Placebo 200mgfrom record
Key inclusion· 8
  • ✓Age 18-60 years (adults) or 12-17 years (adolescents, 16-17 in EU)
  • ✓Confirmed diagnosis of idiopathic IC-MPGN by kidney biopsy within 12 months (adults) or 3 years (adolescents) prior to screening
  • ✓On maximally recommended/tolerated dose of RASi (ACEi or ARB) for at least 90 days prior to randomization
  • ✓Stable doses of proteinuria-reducing agents (MPAs, corticosteroids, SGLT2 inhibitors, MRAs) for at least 90 days prior to randomization
Key exclusion· 15
  • ✕Prior cell or solid organ transplantation, including kidney transplantation
  • ✕Secondary IC-MPGN from chronic infections (HCV, HBV, bacterial endocarditis, visceral abscesses, leprosy, meningococcal meningitis, malaria, schistosomiasis)
  • ✕Secondary IC-MPGN from systemic autoimmune diseases (SLE, Sjögren syndrome, rheumatoid arthritis, mixed connective tissue disease)
  • ✕Monoclonal gammopathy (MGUS) confirmed by serum free light chains or other investigation

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05755386
NCT05755386Phase 3RecruitingOn Track
CompareCT.gov

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)

Novartis Pharmaceuticals·interventional·Posted Mar 6, 2023·Updated Jun 1, 2026

In Brief

A Phase 3 clinical trial evaluating Placebo and iptacopan for IC-MPGN. Currently recruiting, targeting 106 participants across 130 sites in 23 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIC-MPGN
CountriesArgentina, Brazil, Canada, Czechia, Denmark, France, Germany, Greece, India, Israel, Italy, Japan, Netherlands, Poland, Slovakia, South Korea, Spain, Switzerland, Taiwan, Turkey (Türkiye), United Kingdom, United States, Vietnam
Collaborators--

Timeline

Phase 3Recruiting
202420252026202720282029
First PostedMar 6, 2023
Enrollment StartOct 2, 2023
Primary CompletionOct 27, 2028
Study CompletionMay 31, 2029
TodayJul 2, 2026
Enrollment to primary: 5.1 yearsPosted 3.3 years agoPrimary completion in 2.3 years

Arms & Interventions

iptacopan 200mg b.i.dexperimental

iptacopan 200mg b.i.d

Drug: iptacopan
Placebo to iptacopan 200mg b.i.d.placebo_comparator

Placebo to iptacopan 200mg b.i.d.

Drug: Placebo

Interventions

Placebodrug

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

iptacopandrug

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