🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in India / NCT04861259
Active, not recruiting Phase 3

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

NCT04861259 · tracked via the Priya Life Science India tracker
Sponsor
Hoffmann-La Roche
Phase
Phase 3
Started
2021-10-22
Last updated
2026-07-21

Condition(s) studied

Atypical Hemolytic Uremic Syndrome

Investigational drug(s) / intervention(s)

Crovalimab

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).

Study summary

This study aims to evaluate the efficacy and safety of crovalimab in adult and adolescent participants with aHUS.

Eligibility

Sex
ALL
Min age
12 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * Body weight \>= 40 kg at screening. * Vaccination against Neisseria meningitidis serotypes A, C, W, and Y; vaccination against serotypes B, according to national vaccination recommendations. * Vaccination against Haemophilus influenzae type B and Streptococcus pneumoniae, according to national vaccination recommendations. * For participants continuing to receive other therapies concomitantly with crovalimab (e.g., immunosuppressants, corticosteroids, mammalian target of rapamycin inhibitor (mTORi) , or calcineurin inhibitors): stable dose for \>=28 days prior to screening and up to the first crovalimab administration. * For female participants of childbearing potential: an agreement to remain abstinent or use contraception. * Female participants of childbearing potential must have a negative serum pregnancy test result within 7 days prior to initiation of crovalimab. * Participants with a prior kidney transplant are eligible if they have a known history of complement-mediated aHUS prior to the kidney transplant. * Onset of initial TMA presentation within 28 days prior to the first dose of crovalimab (for Naive Cohort only). * Documented treatment with either eculizumab or ravulizumab (for Switch Cohort only). * Clinical evidence of response to a C5 inhibitor (for Switch Cohort only). * Known C5 polymorphism (for C5 SNP Cohort only). * Poorly controlled TMA following treatment with another C5 inhibitor (for C5 SNP Cohort only). Exclusion Criteria: * TMA associated with non-aHUS related renal disease. * Positive direct Coombs test. * Chronic dialysis within 90 days prior to first crovalimab administration and/or end stage renal disease. * Identified drug exposure-related TMA. * Presence or history of a condition that could trigger TMA, such as malignancy, bone marrow or organ transplant (other than kidney transplant) or autoimmune disease. * History of a kidney disease, other than aHUS. * History of Neisseria meningitidis infection within 6 months of study enrollment. * Known or suspected immune deficiency (e.g., history of frequent recurrent infections). * Positive Human Immunodeficiency Virus (HIV) test. * Active systemic bacterial, viral, or fungal infection within 14 days before first crovalimab administration * Presence of fever (\>= 38°C) * Multi-system organ dysfunction or failure. * Recent intravenous immunoglobulin (IVIg) treatment. * Pregnant or breastfeeding or intending to become pregnant. * Participation in another interventional treatment study with an investigational agent or use of any experimental therapy within 28 days of screening or within five half lives of that investigational product, whichever is greater. * Recent use of tranexamic acid. * Current or previous treatment with a complement inhibitor (for Naive Cohort only). * First initiation of plasma exchange/plasma infusions (PE/PI) should not be more than 28 days prior to first crovalimab administration (for Naive Cohort only). * Last PE/PI completed less than 2 hours prior to first crovalimab administration (for Naive Chorot only). * Receiving PE/PI within 8 weeks of the first crovalimab administration (Switch Cohort only). * Positive for active Hepatitis B and C infection (HBV/HCV) (for Switch Cohort and C5 SNP Cohort participants who recently received C5 inhibitor treatment). * Cryoglobulinemia at screening (for Switch Cohort and C5 SNP Cohort participants who recently received C5 inhibitor treatment). * Diagnosis of condition leading to non-aHUS TMA: Thrombotic Thrombocytopenic Purpura (TTP), Shiga Toxin producing Escherichia Coli (STEC) * TMA, Pneumococcal HUS, TMA secondary to cobalamin C defect and TMA related to a known DGKE nephropathy.

Primary outcome measure(s)

Trial sites (42)

FacilityCityRegionStatus
Univ of CA San Francisco San Francisco California
Children's Hospital Colorado Aurora Colorado
Emory Children's Center Atlanta Georgia
Washington University St Louis Missouri
The Ohio State University Wexner Medical Center Columbus Ohio
UT Health Science Center San Antonio Texas
UZ Leuven Gasthuisberg Leuven Belgium
Santa Casa de Misericordia Belo Horizonte Minas Gerais
UPECLIN Hospital das Clinicas da Faculdade de Medicina de Botucatu Botucatu São Paulo
Hospital das Clinicas - FMUSP São Paulo São Paulo
Vancouver General Hospital Vancouver British Columbia
Peking University First Hospital Beijing China
Hopital Lapeyronie Montpellier France
Hôpital Robert Debré Paris France
Hopital Tenon Paris France
Klinik II für Nephrologie, Rheumatologie, Diabetologie und Allgemeine Innere Medizin Cologne Germany
Universitätsklinikum Essen Essen Germany
Klinik für Nephrologie des Universitätsklinikum Essen Essen Germany
Medizinische Hochschule Hannover Hanover Germany
Del- Pesti Centrumkorhaz- Szent Laszlo Korhaz Telephely Budapest Hungary
Medanta-The Medicity Gurgaon Haryana
All India Institute Of Medical Sciences (AIIMS) New Delhi National Capital Territory of Delhi
Rambam Medical Center Haifa Israel
Rabin Medical Center Petah Tikva Israel
Sheba MC Ramat Gan Israel
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Lazio
A.O. Universitaria S. Martino Di Genova Genoa Liguria
Nagoya University Hospital Aichi Japan
Saitama Medical University Hospital Saitama Japan
The University of Tokyo Hospital Tokyo Japan
Hospital General de México Distrito Federal Mexico CITY (federal District)
Instituto Nacional de Ciencias Mexico City Mexico CITY (federal District)
Hospital Universitario "Dr. Jose Eleuterio Gonzalez" Monterrey Nuevo León
Hospital de Especialidades Puerta de Hierro S.A de C.V. Zapopan Mexico
Instytut ?Centrum Zdrowia Matki Polki Lodz Poland
Complejo Hospitalario Universitario A Coruña (CHUAC) A Coruña Spain
Hospital Clinic i Provincial Barcelona Spain
Hospital Universitario Virgen del Rocío Seville Spain
Istanbul University Istanbul Medical Faculty Istanbul Turkey (Türkiye)
Kocaeli University Medical Faculty Kocaeli Turkey (Türkiye)

+ 2 more sites — see the full list on the official registry below.

More Hoffmann-La Roche trials in India

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04861259 on ClinicalTrials.gov ↗ ← All trials in India