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

JRCT ID: jRCT2031210061

Registered date:27/04/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Atypical Hemolytic Uremic Syndrome
• Date of first enrollment: 10/05/2022
• Target sample size: 90
• Countries of recruitment: BELGIUM,Japan,BRAZIL,Japan,CANADA,Japan,CHINA,Japan,FRANCE,Japan,GERMANY,Japan,HUNGARY,Japan,ISRAEL,Japan,ITALY,Japan,MEXICO,Japan,PERU,Japan,POLAND,Japan,SOUTH AFRICA,Japan,SPAIN,Japan,TURKEY,Japan,UNITED STATES,Japan
• Study type: Interventional
• Intervention(s): RO7112689 (crovalimab): Intravenous and Subcutaneous

Outcome(s)

Primary Outcome

efficacy
Percentage of Participants with complete TMA response

Secondary Outcome

safety, efficacy, phamacokinetics, phamacodynamics
Safety(adverse events), Pharmacodynamics(Complement activity, C5)

Key inclusion & exclusion criteria

• Age minimum: >= 12age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude criteria

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

Related Information

• Primary Sponsor: Camelia Sima
• Secondary ID(s): NCT04861259