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

Primary Purpose

Atypical Hemolytic Uremic Syndrome

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Crovalimab
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atypical Hemolytic Uremic Syndrome

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 patients continuing to receive other therapies concomitantly with crovalimab (e.g., immunosuppressants, corticosteroids, 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 patients 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 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 HIV test.
  • Active systemic bacterial, viral, or fungal infection within 14 days before first crovalimab administration
  • Presence of fever (>= 38oC) within 7 days before the first crovalimab administration
  • Multi-system organ dysfunction or failure.
  • Recent 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).
  • PE/PI should not be administered within 6 hours of first crovalimab administration (for Naive Cohort 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).
  • Documented 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 Diacylglycerol kinase ε (DGKE) nephropathy.

Sites / Locations

  • University of California Irvine Chao Family Comprehensive Cancer CenterRecruiting
  • University of California DavisRecruiting
  • Univ of CA San FranciscoRecruiting
  • Children's Hospital Colorado
  • Memorial Healthcare SystemsRecruiting
  • Emory Children's CenterRecruiting
  • Harvard Institutes of MedicineRecruiting
  • Washington UniversityRecruiting
  • SUNY at Stony BrookRecruiting
  • Cincinnati Children's Hospital Medical CenterRecruiting
  • The Ohio State University Wexner Medical CenterRecruiting
  • UT Health Science Center; SouthTexas Pediatric Blood and Cancer Ctr
  • UZ Leuven GasthuisbergRecruiting
  • Santa Casa de Misericordia; de Belo Horizonte
  • UPECLIN Hospital das Clinicas da Faculdade de Medicina de Botucatu
  • Hospital das Clinicas - FMUSP
  • Hospital Samaritano
  • Vancouver General HospitalRecruiting
  • St. Michael's HospitalRecruiting
  • Toronto General HospitalRecruiting
  • Beijing Children's Hospital, Capital Medical UniversityRecruiting
  • Peking University First Hospital; NEPHROLOGYRecruiting
  • Hopital Lapeyronie; NephrologieRecruiting
  • Hôpital Arnaud de Villeneuve; Néphrologie pédiatriqueRecruiting
  • Hôpital Robert Debré; Nephrologie pediatriqueRecruiting
  • Gh Necker Enfants Malades; NephrologieRecruiting
  • Hopital Tenon; Service SINRARecruiting
  • Universitätsklinikum Essen; Klinik für Kinder- und Jugendmedizin Pädiatrie IIRecruiting
  • Klinik für Nephrologie des Universitätsklinikum Essen; Klinik für Infektiologie - MFZRecruiting
  • Medizinische Hochschule Hannover; Klinik für Nieren- und HochdruckerkrankungenRecruiting
  • Klinik II für Nephrologie, Rheumatologie, Diabetologie und Allgemeine Innere MedizinRecruiting
  • Del- Pesti Centrumkorhaz- Szent Laszlo Korhaz TelephelyRecruiting
  • Rambam Medical Center; Department of Nephrology and Hypertension
  • Rabin Medical Center; NephrologyRecruiting
  • Sheba MC; NephrologyRecruiting
  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS; U.O.C. NefrologiaRecruiting
  • A.O. Universitaria S. Martino Di Genova; NefrologiaRecruiting
  • Presidio Ospedaliero Maggiore Policlinico Fondazione IRCCS; Pad Croff Div Nefrologia DialisiRecruiting
  • Az. Osp. Careggi; Reparto Di Nefrologia, Dialisi E TrapiantiRecruiting
  • Nagoya University HospitalRecruiting
  • Mie University HospitalRecruiting
  • Saitama Medical University HospitalRecruiting
  • The University of Tokyo HospitalRecruiting
  • Hospital de Especialidades Puerta de Hierro S.A de C.V.Recruiting
  • Instituto Nacional de Ciencias; Medicas y Nutricion; Salvador ZubiranRecruiting
  • Hospital General de México
  • Hospital Universitario "Dr. Jose Eleuterio Gonzalez"Recruiting
  • Centro para el Desarrollo de la Medicina y de Asistencia
  • Hospital IV Alberto Sabogal Sologuren; Unidad de InvestigacionRecruiting
  • Hospital Nacional Dos de MayoRecruiting
  • Uniwersyteckie Centrum Kliniczne; Klinika Chorob Nerek i Nadci?nienia Dzieci i MlodziezyRecruiting
  • Instytut ?Centrum Zdrowia Matki Polki; Klinika Pediatrii i Immunologii i Nefrologii
  • SAMODZIELNY PUBLICZNY CENTRALNY SZPITAL KLINICZNY; Department KLINIKA NEFROLOGII, DIALIZOTERAPII I CRecruiting
  • Szpital Kliniczny nr 1 im. prof. Szyszko; Oddz. Nefrologii Dzieciecej z Pododdzia?em DializoterapiiRecruiting
  • Red Cross War Memorial Children's Hospital; Pediatric NephrologyRecruiting
  • Inkosi Albert Luthuli Central Hospital; Pediatric Nephrology
  • Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de NefrologiaRecruiting
  • Hospital Clinic i Provincial; Servicio de NefrologiaRecruiting
  • Hospital Universitario 12 de Octubre; Servicio de NefrologiaRecruiting
  • Hospital Universitario Virgen del RocíoRecruiting
  • Istanbul University Istanbul Medical Faculty; Department of Internal Medicine
  • Erciyes University Medical Faculty; Internal MedicineRecruiting
  • Kocaeli University Medical FacultyRecruiting
  • Necmettin Erbakan University Meram Medical Faculty ; Internal DiseasesRecruiting
  • Inonu University Faculty of Medicine Turgut Ozal Medical Center
  • Malatya Park HospitalRecruiting
  • Ondokuz Mayis Univ. Med. Fac.Recruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Crovalimab

Arm Description

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 C5 inhibitor and [3] C5 SNP (Single Nucleotide Polymorphism) Cohort - participants with documented C5 polymorphism.

Outcomes

Primary Outcome Measures

Percentage of Participants with complete TMA response (cTMAr)

Secondary Outcome Measures

Change from Baseline in Dialysis Status
Change from Baseline in Estimated Glomerular Filtration Rate (eGFR)
Percentage of Participants with Change from Baseline in Chronic Kidney Disease (CKD) stage
Observed Value in Platelet Count
Observed Value in Lactate Dehydrogenase (LDH)
Observed Value in Hemoglobin
Change from Baseline in Platelet Count
Change from Baseline in Lactate Dehydrogenase (LDH)
Change from Baseline in Hemoglobin
Mean Change From Baseline in Fatigue (in Adult Participants only)
Assessed by the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Questionnaire. The FACIT-Fatigue (version 4) assesses self-reported fatigue and its impact upon daily activities and function. It consists of 13 items that assess fatigue using a 7-day recall period. Items are scored on a 0 (not at all) to 4 (very much) response scale. Relevant items are reverse scored and all items are summed to create total scores ranging from 0 [worse score] to 52 [better score].
Percentage of Participants with Platelet Count >= Lower Limits of Normal (LLN) (Naive Cohort only)
Percentage of Participants with Normalization of LDH (i.e. =< Upper Limit of Normal (ULN)) (Naive Cohort only)
Percentage of Participants with >=25% decrease in Serum Creatinine (Naive Cohort only)
Time to complete TMA response (cTMAr) (Naive Cohort only)
Duration of complete TMA response (cTMAr) (Naive Cohort only)
Percentage of Participants with complete TMA response (cTMAr) (Naive Cohort only)
Percentage of Participants with maintained TMA control (mTMAc) (Switch Cohort only)
Percentage of Participants with Adverse Events (AEs)
Percentage of Participants with Injection-Site Reactions, Infusion-Related Reactions, Hypersensitivity, Malignant Hypertension (including malignant renal hypertension) and Infections (including meningococcal meningitis)
Percentage of Participants with Adverse Events (AEs) leading to Study Drug Discontinuation
Percentage of Participants with Clinical Manifestations of Drug-Target-Drug Complex (DTDC) Formation Amongst Those Participants who Switched to Crovalimab Treatment From Eculizumab Treatment or Ravulizumab Treatment
Serum Concentrations of Crovalimab Over Time
Percentage of Participants with Anti-Crovalimab Antibodies

Full Information

First Posted
April 23, 2021
Last Updated
October 4, 2023
Sponsor
Hoffmann-La Roche
Collaborators
Chugai Pharmaceutical
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1. Study Identification

Unique Protocol Identification Number
NCT04861259
Brief Title
A Study Evaluating the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Crovalimab in Adult and Adolescent Participants With Atypical Hemolytic Uremic Syndrome (aHUS)
Acronym
COMMUTE-a
Official Title
A Phase III, Multicenter, Single-Arm Study Evaluating the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Crovalimab in Adult and Adolescent Patients With Atypical Hemolytic Uremic Syndrome (aHUS)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 22, 2021 (Actual)
Primary Completion Date
June 13, 2025 (Anticipated)
Study Completion Date
December 7, 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
Collaborators
Chugai Pharmaceutical

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atypical Hemolytic Uremic Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Crovalimab
Arm Type
Experimental
Arm Description
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 C5 inhibitor and [3] C5 SNP (Single Nucleotide Polymorphism) Cohort - participants with documented C5 polymorphism.
Intervention Type
Drug
Intervention Name(s)
Crovalimab
Intervention Description
Crovalimab will be administered at a dose of 1000 mg IV (for participants with body weight between 40 and 100kg) 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 SC. On Week 5 and Q4W thereafter, it will be administered at a dose of 680 mg SC (for participants with body weight between 40 and 100kg) or 1020 mg SC (for participants with body weight >=100kg).
Primary Outcome Measure Information:
Title
Percentage of Participants with complete TMA response (cTMAr)
Time Frame
Baseline up to Week 25
Secondary Outcome Measure Information:
Title
Change from Baseline in Dialysis Status
Time Frame
Baseline up to Week 25
Title
Change from Baseline in Estimated Glomerular Filtration Rate (eGFR)
Time Frame
Baseline up to Week 25
Title
Percentage of Participants with Change from Baseline in Chronic Kidney Disease (CKD) stage
Time Frame
Baseline up to Week 25
Title
Observed Value in Platelet Count
Time Frame
Baseline up to Week 25
Title
Observed Value in Lactate Dehydrogenase (LDH)
Time Frame
Baseline up to Week 25
Title
Observed Value in Hemoglobin
Time Frame
Baseline up to Week 25
Title
Change from Baseline in Platelet Count
Time Frame
Baseline up to Week 25
Title
Change from Baseline in Lactate Dehydrogenase (LDH)
Time Frame
Baseline up to Week 25
Title
Change from Baseline in Hemoglobin
Time Frame
Baseline up to Week 25
Title
Mean Change From Baseline in Fatigue (in Adult Participants only)
Description
Assessed by the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Questionnaire. The FACIT-Fatigue (version 4) assesses self-reported fatigue and its impact upon daily activities and function. It consists of 13 items that assess fatigue using a 7-day recall period. Items are scored on a 0 (not at all) to 4 (very much) response scale. Relevant items are reverse scored and all items are summed to create total scores ranging from 0 [worse score] to 52 [better score].
Time Frame
Baseline up to Week 25
Title
Percentage of Participants with Platelet Count >= Lower Limits of Normal (LLN) (Naive Cohort only)
Time Frame
Baseline up to Week 25
Title
Percentage of Participants with Normalization of LDH (i.e. =< Upper Limit of Normal (ULN)) (Naive Cohort only)
Time Frame
Baseline up to Week 25
Title
Percentage of Participants with >=25% decrease in Serum Creatinine (Naive Cohort only)
Time Frame
Baseline up to Week 25
Title
Time to complete TMA response (cTMAr) (Naive Cohort only)
Time Frame
Up to 9 years
Title
Duration of complete TMA response (cTMAr) (Naive Cohort only)
Time Frame
Up to 9 years
Title
Percentage of Participants with complete TMA response (cTMAr) (Naive Cohort only)
Time Frame
Week 25
Title
Percentage of Participants with maintained TMA control (mTMAc) (Switch Cohort only)
Time Frame
Baseline through Week 25
Title
Percentage of Participants with Adverse Events (AEs)
Time Frame
Up to 9 years
Title
Percentage of Participants with Injection-Site Reactions, Infusion-Related Reactions, Hypersensitivity, Malignant Hypertension (including malignant renal hypertension) and Infections (including meningococcal meningitis)
Time Frame
Up to 9 years
Title
Percentage of Participants with Adverse Events (AEs) leading to Study Drug Discontinuation
Time Frame
Up to 9 years
Title
Percentage of Participants with Clinical Manifestations of Drug-Target-Drug Complex (DTDC) Formation Amongst Those Participants who Switched to Crovalimab Treatment From Eculizumab Treatment or Ravulizumab Treatment
Time Frame
Up to Week 25
Title
Serum Concentrations of Crovalimab Over Time
Time Frame
Up to 9 years
Title
Percentage of Participants with Anti-Crovalimab Antibodies
Time Frame
Up to 9 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 ) within 7 days before the first crovalimab administration 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). Documented 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Reference Study ID Number: BO42353 https://forpatients.roche.com/
Phone
888-662-6728 (U.S. and Canada)
Email
global-roche-genentech-trials@gene.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
University of California Irvine Chao Family Comprehensive Cancer Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Individual Site Status
Recruiting
Facility Name
University of California Davis
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Individual Site Status
Recruiting
Facility Name
Univ of CA San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143-0435
Country
United States
Individual Site Status
Recruiting
Facility Name
Children's Hospital Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Memorial Healthcare Systems
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Individual Site Status
Recruiting
Facility Name
Emory Children's Center
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
20010
Country
United States
Individual Site Status
Recruiting
Facility Name
Harvard Institutes of Medicine
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Name
Washington University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63128
Country
United States
Individual Site Status
Recruiting
Facility Name
SUNY at Stony Brook
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11790
Country
United States
Individual Site Status
Recruiting
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Individual Site Status
Recruiting
Facility Name
The Ohio State University Wexner Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43212
Country
United States
Individual Site Status
Recruiting
Facility Name
UT Health Science Center; SouthTexas Pediatric Blood and Cancer Ctr
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
UZ Leuven Gasthuisberg
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Santa Casa de Misericordia; de Belo Horizonte
City
Belo Horizonte
State/Province
MG
ZIP/Postal Code
30150-221
Country
Brazil
Individual Site Status
Active, not recruiting
Facility Name
UPECLIN Hospital das Clinicas da Faculdade de Medicina de Botucatu
City
Botucatu
State/Province
SP
ZIP/Postal Code
18618-686
Country
Brazil
Individual Site Status
Active, not recruiting
Facility Name
Hospital das Clinicas - FMUSP
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
05403-010
Country
Brazil
Individual Site Status
Active, not recruiting
Facility Name
Hospital Samaritano
City
São Paulo
State/Province
SP
ZIP/Postal Code
01232-010
Country
Brazil
Individual Site Status
Withdrawn
Facility Name
Vancouver General Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1L8
Country
Canada
Individual Site Status
Recruiting
Facility Name
St. Michael's Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada
Individual Site Status
Recruiting
Facility Name
Toronto General Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada
Individual Site Status
Recruiting
Facility Name
Beijing Children's Hospital, Capital Medical University
City
Beijing City
ZIP/Postal Code
100045
Country
China
Individual Site Status
Recruiting
Facility Name
Peking University First Hospital; NEPHROLOGY
City
Beijing
ZIP/Postal Code
100034
Country
China
Individual Site Status
Recruiting
Facility Name
Hopital Lapeyronie; Nephrologie
City
Montpellier
ZIP/Postal Code
34295
Country
France
Individual Site Status
Recruiting
Facility Name
Hôpital Arnaud de Villeneuve; Néphrologie pédiatrique
City
Montpellier
ZIP/Postal Code
34295
Country
France
Individual Site Status
Recruiting
Facility Name
Hôpital Robert Debré; Nephrologie pediatrique
City
Paris
ZIP/Postal Code
75019
Country
France
Individual Site Status
Recruiting
Facility Name
Gh Necker Enfants Malades; Nephrologie
City
Paris
ZIP/Postal Code
75743
Country
France
Individual Site Status
Recruiting
Facility Name
Hopital Tenon; Service SINRA
City
Paris
ZIP/Postal Code
75970
Country
France
Individual Site Status
Recruiting
Facility Name
Universitätsklinikum Essen; Klinik für Kinder- und Jugendmedizin Pädiatrie II
City
Essen
ZIP/Postal Code
45122
Country
Germany
Individual Site Status
Recruiting
Facility Name
Klinik für Nephrologie des Universitätsklinikum Essen; Klinik für Infektiologie - MFZ
City
Essen
ZIP/Postal Code
45147
Country
Germany
Individual Site Status
Recruiting
Facility Name
Medizinische Hochschule Hannover; Klinik für Nieren- und Hochdruckerkrankungen
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Individual Site Status
Recruiting
Facility Name
Klinik II für Nephrologie, Rheumatologie, Diabetologie und Allgemeine Innere Medizin
City
Köln
ZIP/Postal Code
50937
Country
Germany
Individual Site Status
Recruiting
Facility Name
Del- Pesti Centrumkorhaz- Szent Laszlo Korhaz Telephely
City
Budapest
ZIP/Postal Code
1097
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Rambam Medical Center; Department of Nephrology and Hypertension
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Individual Site Status
Active, not recruiting
Facility Name
Rabin Medical Center; Nephrology
City
Petach Tikva
ZIP/Postal Code
0049100
Country
Israel
Individual Site Status
Recruiting
Facility Name
Sheba MC; Nephrology
City
Ramat-Gan
ZIP/Postal Code
5262000
Country
Israel
Individual Site Status
Recruiting
Facility Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS; U.O.C. Nefrologia
City
Roma
State/Province
Lazio
ZIP/Postal Code
00168
Country
Italy
Individual Site Status
Recruiting
Facility Name
A.O. Universitaria S. Martino Di Genova; Nefrologia
City
Genova
State/Province
Liguria
ZIP/Postal Code
16132
Country
Italy
Individual Site Status
Recruiting
Facility Name
Presidio Ospedaliero Maggiore Policlinico Fondazione IRCCS; Pad Croff Div Nefrologia Dialisi
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20122
Country
Italy
Individual Site Status
Recruiting
Facility Name
Az. Osp. Careggi; Reparto Di Nefrologia, Dialisi E Trapianti
City
Firenze
State/Province
Toscana
ZIP/Postal Code
50139
Country
Italy
Individual Site Status
Recruiting
Facility Name
Nagoya University Hospital
City
Aichi
ZIP/Postal Code
466-8560
Country
Japan
Individual Site Status
Recruiting
Facility Name
Mie University Hospital
City
Mie
ZIP/Postal Code
514-8507
Country
Japan
Individual Site Status
Recruiting
Facility Name
Saitama Medical University Hospital
City
Saitama
ZIP/Postal Code
350-0451
Country
Japan
Individual Site Status
Recruiting
Facility Name
The University of Tokyo Hospital
City
Tokyo
ZIP/Postal Code
113-8655
Country
Japan
Individual Site Status
Recruiting
Facility Name
Hospital de Especialidades Puerta de Hierro S.A de C.V.
City
Zapopan
State/Province
Jalisco
ZIP/Postal Code
45116
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Instituto Nacional de Ciencias; Medicas y Nutricion; Salvador Zubiran
City
Ciudad de México
State/Province
Mexico CITY (federal District)
ZIP/Postal Code
14080
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Hospital General de México
City
Distrito Federal
State/Province
Mexico CITY (federal District)
ZIP/Postal Code
06726
Country
Mexico
Individual Site Status
Active, not recruiting
Facility Name
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
City
Monterrey
State/Province
Nuevo LEON
ZIP/Postal Code
64460
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Centro para el Desarrollo de la Medicina y de Asistencia
City
Culiacán Rosales
State/Province
Sinaloa
ZIP/Postal Code
80230
Country
Mexico
Individual Site Status
Withdrawn
Facility Name
Hospital IV Alberto Sabogal Sologuren; Unidad de Investigacion
City
Bellavista
ZIP/Postal Code
Callao 2
Country
Peru
Individual Site Status
Recruiting
Facility Name
Hospital Nacional Dos de Mayo
City
Lima
Country
Peru
Individual Site Status
Recruiting
Facility Name
Uniwersyteckie Centrum Kliniczne; Klinika Chorob Nerek i Nadci?nienia Dzieci i Mlodziezy
City
Gdansk
ZIP/Postal Code
80-952
Country
Poland
Individual Site Status
Recruiting
Facility Name
Instytut ?Centrum Zdrowia Matki Polki; Klinika Pediatrii i Immunologii i Nefrologii
City
Lodz
ZIP/Postal Code
93-338
Country
Poland
Individual Site Status
Active, not recruiting
Facility Name
SAMODZIELNY PUBLICZNY CENTRALNY SZPITAL KLINICZNY; Department KLINIKA NEFROLOGII, DIALIZOTERAPII I C
City
Warszawa
ZIP/Postal Code
02-097
Country
Poland
Individual Site Status
Recruiting
Facility Name
Szpital Kliniczny nr 1 im. prof. Szyszko; Oddz. Nefrologii Dzieciecej z Pododdzia?em Dializoterapii
City
Zabrze
ZIP/Postal Code
41-800
Country
Poland
Individual Site Status
Recruiting
Facility Name
Red Cross War Memorial Children's Hospital; Pediatric Nephrology
City
Rondebosch
ZIP/Postal Code
7700
Country
South Africa
Individual Site Status
Recruiting
Facility Name
Inkosi Albert Luthuli Central Hospital; Pediatric Nephrology
City
Umkumbaan
ZIP/Postal Code
4091
Country
South Africa
Individual Site Status
Withdrawn
Facility Name
Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Nefrologia
City
La Coruna
State/Province
LA Coruña
ZIP/Postal Code
15006
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Clinic i Provincial; Servicio de Nefrologia
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario 12 de Octubre; Servicio de Nefrologia
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Virgen del Rocío
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Individual Site Status
Recruiting
Facility Name
Istanbul University Istanbul Medical Faculty; Department of Internal Medicine
City
Istanbul
ZIP/Postal Code
34390
Country
Turkey
Individual Site Status
Active, not recruiting
Facility Name
Erciyes University Medical Faculty; Internal Medicine
City
Kayseri
ZIP/Postal Code
38039
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Kocaeli University Medical Faculty
City
Kocaeli
ZIP/Postal Code
41380
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Necmettin Erbakan University Meram Medical Faculty ; Internal Diseases
City
Konya
ZIP/Postal Code
42080
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Inonu University Faculty of Medicine Turgut Ozal Medical Center
City
Malatya
ZIP/Postal Code
44280
Country
Turkey
Individual Site Status
Withdrawn
Facility Name
Malatya Park Hospital
City
Malatya
ZIP/Postal Code
44330
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Ondokuz Mayis Univ. Med. Fac.
City
Samsun
ZIP/Postal Code
55139
Country
Turkey
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

Learn more about this trial

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

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