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RECRUITING
NCT06994845
PHASE3

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

Sponsor: Novartis Pharmaceuticals

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.

Official title: A Single-arm, Multicenter, Phase III Study to Assess Efficacy, Pharmacokinetics, Safety and Tolerability of Iptacopan in Pediatric Patients of 2 to <18 Years of Age With Primary Immunoglobulin A Nephropathy (IgAN)

Key Details

Gender

All

Age Range

2 Years - 18 Years

Study Type

INTERVENTIONAL

Enrollment

31

Start Date

2025-11-27

Completion Date

2030-06-30

Last Updated

2026-04-01

Healthy Volunteers

No

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

Locations (15)

Childrens Hospital Colorado

Aurora, Colorado, United States

Childrens Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Prim Childrens Hosp Inv Pharm

Salt Lake City, Utah, United States

Novartis Investigative Site

Brisbane, Queensland, Australia

Novartis Investigative Site

Nedlands, Western Australia, Australia

Novartis Investigative Site

Hangzhou, Zhejiang, China

Novartis Investigative Site

Beijing, China

Novartis Investigative Site

Hong Kong, Hong Kong

Novartis Investigative Site

Beersheba, Israel

Novartis Investigative Site

Haifa, Israel

Novartis Investigative Site

Jerusalem, Israel

Novartis Investigative Site

Petah Tikva, Israel

Novartis Investigative Site

Kurume, Fukuoka, Japan

Novartis Investigative Site

Ohtsu, Shiga, Japan

Novartis Investigative Site

Fuchū, Tokyo, Japan