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

NCT06994845 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2026-04-01

No results posted yet for this study

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.

Conditions

  • Primary Immunoglobulin A Nephropathy (IgAN)

Interventions

DRUG

iptacopan

Cohort 1 (12 to \< 18 years of age): Iptacopan 200 mg b.i.d.(twice daily) Cohort 2 (2 to \< 12 years old): Dosing tbd

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-27
Primary Completion
2030-06-28
Completion
2030-06-30
FDA Drug
Yes

Countries

  • United States
  • Australia
  • China
  • Hong Kong
  • Israel
  • Japan

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06994845 on ClinicalTrials.gov