A Study Evaluating the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Crovalimab in Pediatric Participants With Atypical Hemolytic Uremic Syndrome (aHUS)

A PHASE III, MULTICENTER, SINGLE-ARM STUDY EVALUATING THE EFFICACY, SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF CROVALIMAB IN PEDIATRIC PATIENTS WITH ATYPICAL HEMOLYTIC UREMIC SYNDROME (aHUS)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2041210086

Enrollment

Registered

2021-10-18

Start date

2022-07-28

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Atypical Hemolytic Uremic Syndrome

Interventions

RO7112689 (crovalimab): Intravenous and Subcutaneous

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Body weight >= 5 kg at screening. Vaccination against Neisseria meningitidis. Participants with a prior kidney transplant are eligible if they have a known history of complement-mediated aHUS prior to the kidney transplant.

Exclusion criteria

Exclusion criteria: TMA associated with non-aHUS related renal disease. Positive direct Coombs test. Chronic dialysis and/or end stage renal disease.

Design outcomes

Primary

Measure	Time frame
Efficacy Percentage of Participants with complete TMA response	—

Secondary

Measure	Time frame
Safety, Efficacy, Phamacokinetics, Phamacodynamics Safety(adverse events), Pharmacodynamics(Complement activity, C5)	—

Countries

Belgium, Brazil, Canada, China, France, Hungary, India, Israel, Italy, Japan, Mexico, Poland, South Africa, Spain, United States

Contacts

Public ContactClinical trials information

Chugai Pharmaceutical Co., Ltd.

clinical-trials@chugai-pharm.co.jp+81-120-189-706

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026