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NCT06994845 · ClinicalTrials.gov registry record · Phase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Iptacopan in Pediatric Patients With Primary IgAN
A Phase 3 study of Primary Immunoglobulin A Nephropathy (IgAN), sponsored by Novartis Pharmaceuticals.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 31
- Enrollment target
- 14
- Study locations
NCT06994845 is a Phase 3 study of Primary Immunoglobulin A Nephropathy (IgAN) that is actively recruiting participants, run by Novartis Pharmaceuticals. The registered enrollment target is 31 participants. The trial reports 14 study locations across 10 states.
The verdict
NCT06994845, a Phase 3 study of Primary Immunoglobulin A Nephropathy (IgAN), is actively recruiting participants, sponsored by Novartis Pharmaceuticals.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 31 participants
- Enrollment target
- 14
- Study locations
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 Studied
Interventions
- DRUG iptacopan
Study Locations (14)
Other
- Novartis Investigative Site - Beijing
- Novartis Investigative Site - Beersheba
- Novartis Investigative Site - Haifa
- Novartis Investigative Site - Jerusalem
- Novartis Investigative Site - Petah Tikva
Colorado
- Childrens Hospital Colorado - Aurora
Florida
- University of Florida Shands Division - Gainesville
Pennsylvania
- Childrens Hospital of Philadelphia - Philadelphia
Utah
- Prim Childrens Hosp Inv Pharm - Salt Lake City
Western Australia
- Novartis Investigative Site - Nedlands
Zhejiang
- Novartis Investigative Site - Hangzhou
Fukuoka
- Novartis Investigative Site - Kurume
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2025-11-27 |
| Est. Completion | 2030-06-30 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06994845
The ClinicalTrials.gov registry entry for NCT06994845 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 31 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Primary Immunoglobulin A Nephropathy (IgAN) appearing as the primary indexed condition, and to 1 intervention - of which iptacopan is the first listed.
NCT06994845 reports 14 study locations spanning 10 distinct geographic areas - top geographies include Other, Colorado, Florida.
Frequently Asked Questions
What is clinical trial NCT06994845 about?
NCT06994845 is a clinical study titled "Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Iptacopan in Pediatric Patients With Primary IgAN". 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.
What is the current status of trial NCT06994845?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 31 participants. The study started on 2025-11-27. Estimated completion is 2030-06-30.
What conditions does trial NCT06994845 study?
This clinical trial studies the following conditions: Primary Immunoglobulin A Nephropathy (IgAN).
What interventions are being tested in trial NCT06994845?
The interventions under investigation include: iptacopan (DRUG).
Who is sponsoring clinical trial NCT06994845?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06994845 being conducted?
This trial has 14 study locations across Colorado, Florida, Pennsylvania, Utah, Western Australia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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