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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: Recruiting Phase 3 study of Primary Immunoglobulin A Nephropathy (IgAN), sponsored by Novartis Pharmaceuticals.

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, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (96% lower). The trial reports 14 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

UPCR is measured based on the geometric mean of 2 FMVs obtained preceding each scheduled visit.

Conditions Studied

Primary Immunoglobulin A Nephropathy (IgAN)

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

FieldValue
Enrollment Target 31 participants
Start Date 2025-11-27
Est. Completion 2030-06-30
Phase Phase 3
Novartis Pharmaceuticals

1,375 total trials

What NCT06994845 shows while recruiting

NCT06994845 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (96% lower).

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 lists 14 locations in 10 states (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.

Learn More About Clinical Trials

How this trial's enrollment target compares

Where NCT06994845's enrollment target sits among peer trials

31 1915th of 2000 higher than 84 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

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More recruiting context for NCT06994845

Source: ClinicalTrials.gov NCT06994845, the US trial registry maintained by the National Library of Medicine. NCT06994845 (small enrollment · multi site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.