At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 518 enrolled
Drug / intervention
Placebo +1 moredrug
Likely dose
Placebo 200mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase III Study to Evaluate the Efficacy and Safety of LNP023 in Primary IgA Nephropathy Patients
In Brief
A Phase 3 clinical trial evaluating Placebo and LNP023 for IgA Nephropathy. Completed, enrolled 518 participants across 177 sites in 35 countries.
Detailed Summary
The study is designed as a multicenter, randomized, double-blind, placebo controlled study to demonstrate the superiority of iptacopan (LNP023) at a dose of 200 mg b.i.d. compared to placebo on top of maximally tolerated ACEi or ARB on reduction of proteinuria and slowing renal disease progression in primary IgA Nephropathy patients.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIgA Nephropathy
CountriesArgentina, Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Czechia, Denmark, France, Germany, Hungary, India, Israel, Italy, Japan, Malaysia, Mexico, Netherlands, Norway, Russia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Taiwan, Thailand, Turkey (Türkiye), United Kingdom, United States, Vietnam
Collaborators--
Timeline
Phase 3CompletedFinished
202120222023202420252026
First PostedOct 2020
Enrollment StartJan 2021
Primary CompletionSep 2025
TodayJul 2026
First PostedOct 8, 2020
Enrollment StartJan 25, 2021
Primary CompletionSep 19, 2025
TodayJul 2, 2026
Enrollment to primary: 4.6 yearsPosted 5.7 years ago
Interventions
Placebodrug
Placebo to LNP023 200mg b.i.d
LNP023drug
LNP023 200mg b.i.d