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

Recruiting Phase 3 Interventional Study
Primary Immunoglobulin A Nephropathy (IgAN)
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
2 – 18
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
31 (estimated)
Sponsor
Novartis Pharmaceuticals · Industry
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About This Trial

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.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Male and female participants 2 to \< 18 years of age as of Day 1. * eGFR ≥ 30 mL/min/1.73m2 where eGFR is calculated using the modified Schwartz formula at Screening and confirmed during the Run-in Period. * Kidney biopsy-proven primary IgAN\*, with biopsy performed within 3 y…
Contacts

Novartis Pharmaceuticals

1-888-669-6682

novartis.email@novartis.com

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Novartis Pharmaceuticals

+41613241111

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