drugset / Trial / NCT06994845
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Iptacopan in Pediatric Patients With Primary IgAN
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2025-11-27
- Primary completion
- 2030-06-28
- Completion
- 2030-06-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Iptacopan | Small molecule | 200 mg | — |