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

JRCT ID: jRCT2041210086

Registered date:18/10/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Atypical Hemolytic Uremic Syndrome
• Date of first enrollment: 28/07/2022
• Target sample size: 45
• Countries of recruitment: Belgium,Japan,Brazil,Japan,Canada,Japan,France,Japan,Hungary,Japan,Israel,Japan,Italy,Japan,China,Japan,Poland,Japan,South Africa,Japan,Spain,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: Not applicable
• Age maximum: <= 17age old
• Gender: Both

Include 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.

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: Mona D. Shah
• Secondary ID(s): NCT04958265