A Phase 3, Open-Label, Single-Arm, Multicenter Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Efficacy, and Safety of Ravulizumab in Pediatric Participants (2 to < 18 years of age) with Primary Immunoglobulin A Nephropathy (IgAN)

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-520167-13-00

Acronym

ALXN1210-IgAN-325

Enrollment

Registered

2025-06-06

Start date

2025-06-17

Completion date

Unknown

Last updated

2025-06-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Immunoglobulin A Nephropathy

Brief summary

To characterize the PK and PD of treatment with ravulizumab IV in pediatric participants to support the extrapolation of efficacy from the adult population

Interventions

DRUGUltomiris 1

DRUG100 mg/11 mL concentrate for solution for infusion

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
To characterize the PK and PD of treatment with ravulizumab IV in pediatric participants to support the extrapolation of efficacy from the adult population	—

Countries

Italy, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026