Clinical Trial

Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Iptacopan in Pediatric Patients With Primary IgAN

Recruiting Phase 3
View on ClinicalTrials.gov →
Summary
The study is an open-label, single arm, multicenter, Phase III study to determine proteinuria reduction, pharmacokinetics (PK), safety and tolerability (including CV surveillance) of iptacopan in primary immunoglobulin A nephropathy (IgAN) pediatric patients aged 2 to \<18 years.
Protocol Amendment History 9 amendments
This ClinicalTrials.gov record has been amended 9 times since 2025-05-20; most recent amendment 2026-05-28.
Status change: Not Yet Recruiting → Recruiting 2025-11-28
Trial Details
NCT Number NCT06994845
Lead Sponsor Novartis Pharmaceuticals
Conditions Primary Immunoglobulin A Nephropathy (IgAN)
Enrollment 31 participants
Start Date 2025-11-27
Primary Completion 2030-06-28 (estimated)
Study Completion 2030-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-06-01