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Recruiting Phase 3 Interventional

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

ClinicalTrials.gov ID: NCT06994845

Public ClinicalTrials.gov record NCT06994845. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 22, 2026, 5:49 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT06994845
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
Novartis Pharmaceuticals
Industry
Enrollment
31 participants

Conditions and interventions

Eligibility (public fields only)

Age range
2 Years to 18 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Nov 27, 2025 (Actual)
Primary completion
Jun 28, 2030 (Estimated)
Completion
Jun 30, 2030 (Estimated)
Last update posted
Sep 9, 2026

2025 – 2030

United States locations

U.S. sites
5
U.S. states
5
U.S. cities
5
Facility City State ZIP Site status
Valley Childrens Hospital Madera California 93636 Recruiting
Childrens Hospital Colorado Aurora Colorado 80045 Recruiting
Univ of Florida Shands Division Gainesville Florida 32610-0224 Recruiting
Childrens Hospital of Philadelphia Philadelphia Pennsylvania 19104-4399 Recruiting
Prim Childrens Hosp Inv Pharm Salt Lake City Utah 84113 Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 15 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT06994845, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Sep 9, 2026 · Synced Oct 22, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT06994845 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →