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

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

83

Participants

Timeline

Start Date

October 22, 2021

Primary Completion Date

October 9, 2025

Study Completion Date

August 20, 2029

Conditions
Atypical Hemolytic Uremic Syndrome
Interventions
DRUG

Crovalimab

Crovalimab will be administered at a dose of 1000 milligrams (mg) intravenous (IV) (for participants with body weight at least 40 (\>=) and up to 100 kilograms (kg) or 1500 mg IV (for participants with body weight \>=100kg) on Week 1 Day 1. On Week 1 Day 2 and on Weeks 2, 3 and 4, it will be administered at a dose of 340 mg subcutaneously (SC). On Week 5 and every 4 weeks (Q4W) thereafter, it will be administered at a dose of 680 mg SC (for participants with body weight \>= 40kg to \<100kg) or 1020 mg SC (for participants with body weight \>=100kg).

Trial Locations (45)

1097

Del- Pesti Centrumkorhaz- Szent Laszlo Korhaz Telephely, Budapest

3000

UZ Leuven Gasthuisberg, Leuven

14080

Instituto Nacional de Ciencias, Mexico City

16132

A.O. Universitaria S. Martino Di Genova, Genoa

20010

Emory Children's Center, Atlanta

30625

Medizinische Hochschule Hannover, Hanover

34295

Hopital Lapeyronie, Montpellier

Hôpital Arnaud de Villeneuve, Montpellier

34390

Istanbul University Istanbul Medical Faculty, Istanbul

41013

Hospital Universitario Virgen del Rocío, Seville

41380

Kocaeli University Medical Faculty, Kocaeli

42080

Necmettin Erbakan University Meram Medical Faculty, Konya

43212

The Ohio State University Wexner Medical Center, Columbus

44330

Malatya Park Hospital, Malatya

45116

Hospital de Especialidades Puerta de Hierro S.A de C.V., Zapopan

45122

Universitätsklinikum Essen, Essen

45147

Klinik für Nephrologie des Universitätsklinikum Essen, Essen

45229

Cincinnati Children's Hospital Medical Center, Cincinnati

49100

Rabin Medical Center, Petah Tikva

50937

Klinik II für Nephrologie, Rheumatologie, Diabetologie und Allgemeine Innere Medizin, Cologne

52621

Sheba MC, Ramat Gan

63110

Washington University, St Louis

64460

"Hospital Universitario Dr. Jose Eleuterio Gonzalez", Monterrey

75019

Hôpital Robert Debré, Paris

75743

Gh Necker Enfants Malades, Paris

75970

Hopital Tenon, Paris

78229

UT Health Science Center, San Antonio

80045

Children's Hospital Colorado, Aurora

92868

University of California Irvine Chao Family Comprehensive Cancer Center, Orange

94143

Univ of CA San Francisco, San Francisco

100034

Peking University First Hospital, Beijing

110029

All India Institute Of Medical Sciences (AIIMS), New Delhi

122001

Medanta-The Medicity, Gurgaon

3109601

Rambam Medical Center, Haifa

30150-221

Santa Casa de Misericordia, Belo Horizonte

18618-686

UPECLIN Hospital das Clinicas da Faculdade de Medicina de Botucatu, Botucatu

05403-000

Hospital das Clinicas - FMUSP, São Paulo

V5Z 2S3

Vancouver General Hospital, Vancouver

00168

Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome

466-8560

Nagoya University Hospital, Aichi

350-0451

Saitama Medical University Hospital, Saitama

113-8655

The University of Tokyo Hospital, Tokyo

06726

Hospital General de México, Distrito Federal

93-338

Instytut ?Centrum Zdrowia Matki Polki, Lodz

08036

Hospital Clinic i Provincial, Barcelona

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Chugai Pharmaceutical

INDUSTRY

lead

Hoffmann-La Roche

INDUSTRY