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Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Iptacopan in Pediatric Patients With Primary IgAN
NCT06994845 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. 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 792 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06994845 reports 14 study locations spanning 10 distinct geographic areas — top geographies include Other, Colorado, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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). These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06994845?
The interventions under investigation include: iptacopan (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06994845?
This trial is sponsored by Novartis Pharmaceuticals, which has 792 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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