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

A Phase III, Multicenter, Single-Arm Study Evaluating the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Crovalimab in Adult and Adolescent Patients with Atypical Hemolytic Uremic Syndrome (aHUS)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2031210061

Enrollment

Registered

2021-04-27

Start date

2022-05-10

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 >=40 kg at screening Vaccination against Neisseria meningitidis Participants with a prior kidney transplant are eligible if they have a know history of complement-medical 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, GERMANY, HUNGARY, ISRAEL, ITALY, Japan, MEXICO, PERU, POLAND, SOUTH AFRICA, SPAIN, TURKEY, 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