A Study Evaluating the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Crovalimab in Adult and Adolescent Participants With Atypical Hemolytic Uremic Syndrome (aHUS)
NCT ID: NCT04861259
Last Updated: 2026-01-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
83 participants
INTERVENTIONAL
2021-10-22
2029-08-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Crovalimab
Participants will be enrolled in three cohorts: \[1\] Naive Cohort - participants who have not been previously treated with complement inhibitor therapy; \[2\] Switch Cohort - participants who switch to crovalimab from another Complement Component 5 (C5) inhibitor and \[3\] C5 Single Nucleotide Polymorphism (C5 inhibitor) Cohort - participants with documented C5 polymorphism.
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).
Interventions
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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).
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
12 Years
ALL
No
Sponsors
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Chugai Pharmaceutical
INDUSTRY
Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Univ of CA San Francisco
San Francisco, California, United States
Children's Hospital Colorado
Aurora, Colorado, United States
Emory Children's Center
Atlanta, Georgia, United States
Washington University
St Louis, Missouri, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States
UT Health Science Center
San Antonio, Texas, United States
UZ Leuven Gasthuisberg
Leuven, , Belgium
Santa Casa de Misericordia
Belo Horizonte, Minas Gerais, Brazil
UPECLIN Hospital das Clinicas da Faculdade de Medicina de Botucatu
Botucatu, São Paulo, Brazil
Hospital das Clinicas - FMUSP
São Paulo, São Paulo, Brazil
Vancouver General Hospital
Vancouver, British Columbia, Canada
Peking University First Hospital
Beijing, , China
Hopital Lapeyronie
Montpellier, , France
Hôpital Arnaud de Villeneuve
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, India
All India Institute Of Medical Sciences (AIIMS)
New Delhi, National Capital Territory of Delhi, India
Rambam Medical Center
Haifa, , Israel
Rabin Medical Center
Petah Tikva, , Israel
Sheba MC
Ramat Gan, , Israel
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, Lazio, Italy
A.O. Universitaria S. Martino Di Genova
Genoa, Liguria, Italy
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), Mexico
Instituto Nacional de Ciencias
Mexico City, Mexico CITY (federal District), Mexico
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
Monterrey, Nuevo León, Mexico
Hospital de Especialidades Puerta de Hierro S.A de C.V.
Zapopan, , Mexico
Instytut ?Centrum Zdrowia Matki Polki
Lodz, , Poland
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)
Necmettin Erbakan University Meram Medical Faculty
Konya, , Turkey (Türkiye)
Malatya Park Hospital
Malatya, , Turkey (Türkiye)
Countries
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Other Identifiers
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2020-002475-35
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2023-505089-27-00
Identifier Type: CTIS
Identifier Source: secondary_id
BO42353
Identifier Type: -
Identifier Source: org_study_id
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