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New hope for rare Kidney-Blood disease: crovalimab trial shows promise

NCT ID NCT04861259

Disease control Sponsor: Hoffmann-La Roche Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 22, 2026 · Updated 2 times

Summary

This study tests a new medicine called crovalimab for people with a rare disease called atypical hemolytic uremic syndrome (aHUS), which causes blood clots and kidney damage. The trial includes 83 adults and teens who receive the drug to see if it can control the disease and improve kidney function. Participants must be up to date on certain vaccines to join.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

83 people

The number who actually took part.

Started

Oct 2021

Expected to finish

Aug 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

12 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

atypical hemolytic-uremic syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Atypical hemolytic uremic syndrome

Contacts and locations

Locations

  • A.O. Universitaria S. Martino Di Genova

    Genoa, Liguria, 16132, Italy

  • All India Institute Of Medical Sciences (AIIMS)

    New Delhi, National Capital Territory of Delhi, 110029, India

  • Children's Hospital Colorado

    Aurora, Colorado, 80045, United States

  • Complejo Hospitalario Universitario A Coruña (CHUAC)

    A Coruña, 15006, Spain

  • Del- Pesti Centrumkorhaz- Szent Laszlo Korhaz Telephely

    Budapest, 1097, Hungary

  • Emory Children's Center

    Atlanta, Georgia, 20010, United States

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Rome, Lazio, 00168, Italy

  • Hopital Lapeyronie

    Montpellier, 34295, France

  • Hopital Tenon

    Paris, 75970, France

  • Hospital Clinic i Provincial

    Barcelona, 08036, Spain

  • Hospital General de México

    Distrito Federal, Mexico CITY (federal District), 06726, Mexico

  • Hospital Universitario "Dr. Jose Eleuterio Gonzalez"

    Monterrey, Nuevo León, 64460, Mexico

  • Hospital Universitario Virgen del Rocío

    Seville, 41013, Spain

  • Hospital das Clinicas - FMUSP

    São Paulo, São Paulo, 05403-000, Brazil

  • Hospital de Especialidades Puerta de Hierro S.A de C.V.

    Zapopan, 45116, Mexico

  • Hôpital Robert Debré

    Paris, 75019, France

  • Instituto Nacional de Ciencias

    Mexico City, Mexico CITY (federal District), 14080, Mexico

  • Instytut ?Centrum Zdrowia Matki Polki

    Lodz, 93-338, Poland

  • Istanbul University Istanbul Medical Faculty

    Istanbul, 34390, Turkey (Türkiye)

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

    Cologne, 50937, Germany

  • Klinik für Nephrologie des Universitätsklinikum Essen

    Essen, 45147, Germany

  • Kocaeli University Medical Faculty

    Kocaeli, 41380, Turkey (Türkiye)

  • Malatya Park Hospital

    Malatya, 44330, Turkey (Türkiye)

  • Medanta-The Medicity

    Gurgaon, Haryana, 122001, India

  • Medizinische Hochschule Hannover

    Hanover, 30625, Germany

  • Nagoya University Hospital

    Aichi, 466-8560, Japan

  • Necmettin Erbakan University Meram Medical Faculty

    Konya, 42080, Turkey (Türkiye)

  • Peking University First Hospital

    Beijing, 100034, China

  • Rabin Medical Center

    Petah Tikva, 49100, Israel

  • Rambam Medical Center

    Haifa, 3109601, Israel

  • Saitama Medical University Hospital

    Saitama, 350-0451, Japan

  • Santa Casa de Misericordia

    Belo Horizonte, Minas Gerais, 30150-221, Brazil

  • Sheba MC

    Ramat Gan, 52621, Israel

  • The Ohio State University Wexner Medical Center

    Columbus, Ohio, 43212, United States

  • The University of Tokyo Hospital

    Tokyo, 113-8655, Japan

  • UPECLIN Hospital das Clinicas da Faculdade de Medicina de Botucatu

    Botucatu, São Paulo, 18618-686, Brazil

  • UT Health Science Center

    San Antonio, Texas, 78229, United States

  • UZ Leuven Gasthuisberg

    Leuven, 3000, Belgium

  • Univ of CA San Francisco

    San Francisco, California, 94143, United States

  • Universitätsklinikum Essen

    Essen, 45122, Germany

  • Vancouver General Hospital

    Vancouver, British Columbia, V5Z 2S3, Canada

  • Washington University

    St Louis, Missouri, 63110, United States

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