Clinical trial • Phase III • Haematology
CROVALIMAB for Atypical hemolytic uremic syndrome
Phase III trial of CROVALIMAB for Atypical hemolytic uremic syndrome. open-label. 62 participants.
Overview
- Trial Therapeutic Area
- Haematology
- Trial Disease
- Atypical hemolytic uremic syndrome
- Trial Stage
- Phase III
- Drug Modality
- Monoclonal antibody
- Paediatric Trial
- Yes
Key dates
- Initial CTIS Submission Date
- 25-01-2024
- First CTIS Authorization Date
- 29-02-2024
Trial design
open-label Phase III trial in Italy, Germany, Hungary and others.
- Open Label
- Yes
- Biomarker Stratified
- True, biomarker: C5 polymorphism (e.g., Arg885) - C5SNP cohort
- Target Sample Size
- 62
Eligibility
Recruits 62 paediatric patients.
- Vulnerable Population
- Vulnerable populations selected. Study includes adolescents and infants (documents include ICFs and assent/authorization forms for ages 12-17, adolescent addenda, infant authorization and parent consent forms). Consent is obtained from adult participants; parental consent is documented for minors/infants and assent forms are provided for adolescents (e.g., assent forms for ages 12-17). Multiple country-specific subject information and informed consent forms and assent/parent documents are available (multiple language versions listed in the trial documents).
Inclusion criteria
- {"criterion_text":"- Vaccination against Neisseria meningitidis < 3 years prior to initiation of study treatment in accordance with current local guidelines or standard of care, as applicable in patients with complement deficiency (for ALL cohorts)\n- Adequate hepatic function, AST and ALT ≤ 3×ULN at the time of screening; no clinical signs or known laboratory/radiographic evidence consistent with cirrhosis (for ALL cohorts)\n- For female patients of childbearing potential, an agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception (for ALL cohorts)\n- Onset of initial TMA presentation, within 28 days prior to the first dose of crovalimab (For naïve cohort only)\n- Clinical evidence of response to either eculizumab or ravulizumab, as documented by a platelet count ≥LLN, LDH ≤ULN, and stable (decrease or increase of ≤20%) or improving creatinine at two consecutive measurements at least 4 weeks apart prior to Week 1 Day 1 of crovalimab treatment. (For switch cohort only)\n- Known C5 polymorphism (e.g., Arg885) (For C5SNP cohort only)"}
Exclusion criteria
- {"criterion_text":"- TMA associated with non-aHUS-related renal disease\n- History of a kidney disease other than aHUS, affecting renal function\n- Known systemic sclerosis (scleroderma), systemic lupus erythematosus, or antiphospholipid antibody positivity or syndrome\n- Active systemic bacterial, viral, or fungal infection within 14 days before first crovalimab administration\n- History of Neisseria meningitidis infection within 6 months of study enrollment\n- History of malignancy within 5 years prior to screening and up to the first crovalimab administration"}
Endpoints
Primary endpoints
- {"endpoint_text":"- 1. Proportion of patients with complete TMA response (cTMAr)","definition_or_measurement_approach":""}
Secondary endpoints
- {"endpoint_text":"- 1. Dialysis requirement status (yes/no) change\n- 2. Observed value and change from baseline in estimated glomerular filtration rate (eGFR)\n- 3. Proportion of patients with change from baseline in chronic kidney disease stage\n- 4. Observed value and change from baseline in hematologic parameters\n- 5. In adults (≥ 18 years), change from baseline in fatigue as measured by the Functional Assessment of Chronic Illness Therapy-Fatigue Questionnaire\n- 6. Incidence and severity of adverse events\n- 7. Change in targeted vital signs and clinical laboratory test results\n- 8. Incidence and severity of injection-site reactions, infusion-related reactions, hypersensitivity, malignant hypertension, and infections\n- 9. Incidence of adverse events leading to study drug discontinuation\n- 10. Serum concentrations of crovalimab\n- 11. Prevalence and incidence of anti-drug antibodies (ADAs) to crovalimab\n- 12. Proportion of patients with platelet count ≥ LLN\n- 13. Proportion of patients with normalization of LDH\n- 14. Proportion of patients with ≥ 25% decrease in serum creatinine from baseline\n- 15. Time to cTMAr\n- 16. Duration of cTMAr\n- 17. Proportion of patients with cTMAr\n- 18. Proportion of patients with maintained TMA control (mTMAc)","definition_or_measurement_approach":""}
Recruitment
- Planned Sample Size
- 62
- Recruitment Window Months
- 97
- Consent Approach
- Informed consent materials and procedures documented. Adult main ICFs are provided for adult participants; parental consent forms and infant authorization forms are provided for infants; assent forms and adolescent addenda (e.g., ages 12-17) are provided for minors. Multiple language versions and country-specific ICFs and assent forms are included in the submitted documents (examples include EN, FR, DE, NL, HU, ES, PL versions listed among the trial documents).
Geography
- Total Number Of Sites
- 23
- Total Number Of Participants
- 19
Italy
- Earliest CTIS Part Ii Submission Date
- 13-02-2024
- Latest Decision Or Authorization Date
- 27-11-2024
- Processing Time Days
- 288
- Number Of Sites
- 4
- Number Of Participants
- 3
Sites
- Site Name
- IRCCS Ospedale Policlinico San Martino
- Department Name
- Clinica Nefrologica Dialisi e Trapianto
- Principal Investigator Name
- Francesca Chiara Viazzi
- Principal Investigator Email
- francesca.viazzi@unige.it
- Contact Person Name
- Francesca Chiara Viazzi
- Contact Person Email
- francesca.viazzi@unige.it
- Site Name
- Careggi University Hospital
- Department Name
- Nefrologia
- Principal Investigator Name
- Calogero Lino Cirami
- Principal Investigator Email
- ciramil@aou-careggi.toscana.it
- Contact Person Name
- Calogero Lino Cirami
- Contact Person Email
- ciramil@aou-careggi.toscana.it
- Site Name
- Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
- Department Name
- Nefrologia, Dialisi e Trapianto Renale
- Principal Investigator Name
- Anna Regalia
- Principal Investigator Email
- anna.regalia@policlinico.mi.it
- Contact Person Name
- Anna Regalia
- Contact Person Email
- anna.regalia@policlinico.mi.it
- Site Name
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Department Name
- UOC Nefrologia
- Principal Investigator Name
- Giuseppe Grandaliano
- Principal Investigator Email
- giuseppe.grandaliano@policlinicogemelli.it
- Contact Person Name
- Giuseppe Grandaliano
- Contact Person Email
- giuseppe.grandaliano@policlinicogemelli.it
Germany
- Earliest CTIS Part Ii Submission Date
- 13-02-2024
- Latest Decision Or Authorization Date
- 02-12-2024
- Processing Time Days
- 293
- Number Of Sites
- 4
- Number Of Participants
- 6
Sites
- Site Name
- Universitaetsklinikum Essen AöR
- Department Name
- Klinik für Nephrologie, Klinik für Infektiologie, Medizinisches Forschungszentrum (MFZ)
- Principal Investigator Name
- Anja Gäckler
- Principal Investigator Email
- anja.gaeckler@uk-essen.de
- Contact Person Name
- Anja Gäckler
- Contact Person Email
- anja.gaeckler@uk-essen.de
- Site Name
- University Hospital Cologne AöR
- Department Name
- Klinik II für Nephrologie, Rheumatologie, Diabetologie und Allgemeine Innere Medizin
- Principal Investigator Name
- Paul Brinkkötter
- Principal Investigator Email
- paul.brinkkoetter@uk-koeln.de
- Contact Person Name
- Paul Brinkkötter
- Contact Person Email
- paul.brinkkoetter@uk-koeln.de
- Site Name
- Medizinische Hochschule Hannover
- Department Name
- Klinik für Nieren- und Hochdruckerkrankungen
- Principal Investigator Name
- Kai Schmidt-Ott
- Principal Investigator Email
- studienzentrum@mh-hannover.de
- Contact Person Name
- Kai Schmidt-Ott
- Contact Person Email
- studienzentrum@mh-hannover.de
- Site Name
- Universitaetsklinikum Essen AöR
- Department Name
- Klinik für Kinder- und Jugendmedizin, Pädiatrie II
- Principal Investigator Name
- Anja Büscher
- Principal Investigator Email
- anja.buescher@uk-essen.de
- Contact Person Name
- Anja Büscher
- Contact Person Email
- anja.buescher@uk-essen.de
Hungary
- Earliest CTIS Part Ii Submission Date
- 13-02-2024
- Latest Decision Or Authorization Date
- 25-11-2024
- Processing Time Days
- 286
- Number Of Sites
- 1
- Number Of Participants
- 1
Sites
- Site Name
- Del-Pesti Centrumkorhaz Orszagos Hematologiai Es Infektologiai Intezet
- Department Name
- Hematologia
- Principal Investigator Name
- Marienn Reti
- Principal Investigator Email
- reti.marienn@dpckorhaz.hu
- Contact Person Name
- Marienn Reti
- Contact Person Email
- reti.marienn@dpckorhaz.hu
Spain
- Earliest CTIS Part Ii Submission Date
- 13-02-2024
- Latest Decision Or Authorization Date
- 29-11-2024
- Processing Time Days
- 290
- Number Of Sites
- 4
- Number Of Participants
- 2
Sites
- Site Name
- Complexo Hospitalario Universitario A Coruna
- Department Name
- Nephrology
- Principal Investigator Name
- Mercedes Cao Vilariño
- Principal Investigator Email
- mercedes.cao.vilarino@sergas.es
- Contact Person Name
- Mercedes Cao Vilariño
- Contact Person Email
- mercedes.cao.vilarino@sergas.es
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Nephrology
- Principal Investigator Name
- Francisco De la Cerda Ojeda
- Principal Investigator Email
- nefroped.hvr.sspa@juntadeandalucia.es
- Contact Person Name
- Francisco De la Cerda Ojeda
- Contact Person Email
- nefroped.hvr.sspa@juntadeandalucia.es
- Site Name
- University Hospital Virgen Del Rocio S.L.
- Department Name
- Nephrology
- Principal Investigator Name
- Jose Luis Rocha Castilla
- Principal Investigator Email
- josel.rocha.sspa@juntadeandalucia.es
- Contact Person Name
- Jose Luis Rocha Castilla
- Contact Person Email
- josel.rocha.sspa@juntadeandalucia.es
- Site Name
- Hospital Clinic De Barcelona
- Department Name
- Nephrology
- Principal Investigator Name
- Luis Quintana Pollas
- Principal Investigator Email
- lfquinta@clinic.cat
- Contact Person Name
- Luis Quintana Pollas
- Contact Person Email
- lfquinta@clinic.cat
France
- Earliest CTIS Part Ii Submission Date
- 13-02-2024
- Latest Decision Or Authorization Date
- 25-11-2024
- Processing Time Days
- 286
- Number Of Sites
- 5
- Number Of Participants
- 3
Sites
- Site Name
- Centre Hospitalier Universitaire De Montpellier
- Department Name
- Hôpital LAPEYRONIE - néphrologie
- Principal Investigator Name
- Moglie LE QUINTREC
- Principal Investigator Email
- m-lequintrec-donnette@chu-montpellier.fr
- Contact Person Name
- Moglie LE QUINTREC
- Contact Person Email
- m-lequintrec-donnette@chu-montpellier.fr
- Site Name
- Centre Hospitalier Universitaire De Montpellier
- Department Name
- Hôpital Arnaud de Villeneuve - néphrologie
- Principal Investigator Name
- Marc FILA
- Principal Investigator Email
- m-fila@chu-montpellier.fr
- Contact Person Name
- Marc FILA
- Contact Person Email
- m-fila@chu-montpellier.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- TENON - Service SINRA
- Principal Investigator Name
- Laurent MESNARD
- Principal Investigator Email
- laurent.mesnard@aphp.fr
- Contact Person Name
- Laurent MESNARD
- Contact Person Email
- laurent.mesnard@aphp.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- GH NECKER - enfants malades - néphrologie
- Principal Investigator Name
- Olivia BOYER
- Principal Investigator Email
- olivia.boyer@aphp.fr
- Contact Person Name
- Olivia BOYER
- Contact Person Email
- olivia.boyer@aphp.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- CHU ROBERT DEBRE - néphrologie pédiatrique
- Principal Investigator Name
- Julien HOGAN
- Principal Investigator Email
- julien.hogan2@aphp.fr
- Contact Person Name
- Julien HOGAN
- Contact Person Email
- julien.hogan2@aphp.fr
Belgium
- Earliest CTIS Part Ii Submission Date
- 13-02-2024
- Latest Decision Or Authorization Date
- 02-12-2024
- Processing Time Days
- 293
- Number Of Sites
- 1
- Number Of Participants
- 2
Sites
- Site Name
- UZ Leuven
- Department Name
- Nephrology
- Principal Investigator Name
- Kathleen Claes
- Principal Investigator Email
- kathleen.claes@uzleuven.be
- Contact Person Name
- Kathleen Claes
- Contact Person Email
- kathleen.claes@uzleuven.be
Poland
- Earliest CTIS Part Ii Submission Date
- 13-02-2024
- Latest Decision Or Authorization Date
- 02-12-2024
- Processing Time Days
- 293
- Number Of Sites
- 4
- Number Of Participants
- 2
Sites
- Site Name
- Uniwersyteckie Centrum Kliniczne
- Department Name
- Klinika Chorób Nerek i Nadciśnienia Dzieci i Młodzieży
- Principal Investigator Name
- Aleksandra Żurowska
- Principal Investigator Email
- nefped@gumed.edu.pl
- Contact Person Name
- Aleksandra Żurowska
- Contact Person Email
- nefped@gumed.edu.pl
- Site Name
- Instytut Centrum Zdrowia Matki Polki
- Department Name
- Klinika Pediatrii i Immunologii i Nefrologii
- Principal Investigator Name
- Marcin Tkaczyk
- Principal Investigator Email
- sek31@iczmp.edu.pl
- Contact Person Name
- Marcin Tkaczyk
- Contact Person Email
- sek31@iczmp.edu.pl
- Site Name
- Samodzielny Publiczny Szpital Kliniczny Nr 1 Im.Prof.Stanislawa Szyszko Slaskiego Uniwersytetu Medycznego W Katowicach
- Department Name
- Oddział Nefrologii Dzieci z Pododdziałem Dializoterapii
- Principal Investigator Name
- Maria Szczepańska
- Principal Investigator Email
- mszczepanska@szpital.zabrze.pl
- Contact Person Name
- Maria Szczepańska
- Contact Person Email
- mszczepanska@szpital.zabrze.pl
- Site Name
- Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego
- Department Name
- Klinika Nefrologii, Dializoterapii i Chorób Wewnętrznych
- Principal Investigator Name
- Jolanta Małyszko
- Principal Investigator Email
- nefrologia@wum.edu.pl
- Contact Person Name
- Jolanta Małyszko
- Contact Person Email
- nefrologia@wum.edu.pl
Sponsor
Primary sponsor
- Full Name
- F. Hoffmann-La Roche AG
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Switzerland
Contract research organisations
- Name
- IQVIA Limited
- Responsibilities
- Global CRO
Third parties
- {"country":"United States","full_name":"Yprime LLC","duties_or_roles":"Other third party duty","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Japan","full_name":"Cmic Pharma Science Co. Ltd.","duties_or_roles":"Specialty Laboratory","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Perceptive Informatics Inc.","duties_or_roles":"3","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Labcorp","duties_or_roles":"Specialty Laboratory","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Fulgent Genetics Inc.","duties_or_roles":"Specialty Laboratory","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"Global CRO","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Labcorp Early Development Laboratories Inc.","duties_or_roles":"Specialty Laboratory","organisation_type":"Pharmaceutical company"}
- {"country":"Ireland","full_name":"Teckro Limited","duties_or_roles":"Medical Communication","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"Specialty Laboratory","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Fortrea Inc.","duties_or_roles":"Specialty Laboratory","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"Q Squared Solutions Limited","duties_or_roles":"Specialty Laboratory","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Spain","full_name":"Secugen S.L.","duties_or_roles":"Specialty Laboratory","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Icon Development Solutions LLC","duties_or_roles":"SampleManagementWhitesboro@iconplc.com","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- Crovalimab
- Active Substance
- CROVALIMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- Subcutaneous; Intravenous
- Route
- Subcutaneous and Intravenous
- Maximum Dose
- 1500 mg per day
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