Phase
Condition
Transplant Rejection
Treatment
Rituximab
BIVV020 (SAR445088)
BIVV020
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
-Participant intended to receive SOC therapy per Investigator's judgment and local practice.
Cohort A: Participants with chronic kidney disease who will receive a kidney transplant from a living or deceased donor.
Cohort B: Participants who are kidney transplant recipients diagnosed with active AMR.
BMI ≤ 40 kg/m2.
Contraceptive use by women during the treatment period, and for at least 49 weeksafter the last administration of IMP (BIVV020 + SOC arm participant) or lasttreatment period visit (SOC arm participant).
Contraceptive use by men during the treatment period, and for at least 49 weeksafter the last administration of IMP (BIVV020 + SOC arm participant) or lasttreatment period visit (SOC arm participant).
Exclusion
Exclusion Criteria:
Participants who are ABO incompatible with their donors.
Participants with known active ongoing infection as per below:
Positive HIV.
Positive HBV.
HCV with detectable HCV RNA.
Within 4 weeks of first study intervention: any serious infection, or anyactive bacterial infection, or any other infection which is clinicallysignificant in the option of the Investigator, unless it can be confirmed thatinfection was cleared at least 3 days prior to first study intervention.
History of active tuberculosis (TB) regardless of treatment.
Participants with clinical diagnosis of systemic lupus erythematosus (SLE).
Prior treatment with complement system inhibitor within 5 times the half-life.
Current enrollment in any other clinical study where the last investigational studytreatment administration was within 5 half-lives from study intervention initiation.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Study Design
Study Description
Connect with a study center
Investigational Site Number : 0360003
Westmead, New South Wales 2145
AustraliaSite Not Available
Investigational Site Number :0360003
Westmead, New South Wales 2145
AustraliaActive - Recruiting
Investigational Site Number : 1240001
Vancouver, British Columbia V6Z 1Y6
CanadaSite Not Available
Investigational Site Number : 1240101
Vancouver, British Columbia V5Z 1M9
CanadaSite Not Available
Investigational Site Number :1240001
Vancouver, British Columbia V6Z 1Y6
CanadaActive - Recruiting
Investigational Site Number :1240101
Vancouver, British Columbia V5Z 1M9
CanadaActive - Recruiting
Investigational Site Number : 1240002
London, Ontario N6A 5A5
CanadaSite Not Available
Investigational Site Number : 1240003
Montreal, Quebec H4A 3J1
CanadaSite Not Available
Investigational Site Number :1240003
Montreal, Quebec H4A 3J1
CanadaActive - Recruiting
Investigational Site Number : 2500007
Bordeaux, 33076
FranceSite Not Available
Investigational Site Number :2500007
Bordeaux, 33000
FranceActive - Recruiting
Investigational Site Number : 2500002
Creteil, 94000
FranceSite Not Available
Investigational Site Number :2500002
Creteil, 94000
FranceActive - Recruiting
Investigational Site Number : 2500002
Créteil, 94010
FranceSite Not Available
Investigational Site Number : 2500001
Paris, 75010
FranceSite Not Available
Investigational Site Number :2500001
Paris, 75010
FranceActive - Recruiting
Investigational Site Number : 2500004
Suresnes, 92150
FranceSite Not Available
Investigational Site Number :2500004
Suresnes, 92150
FranceActive - Recruiting
Investigational Site Number : 2500005
Toulouse, 31059
FranceSite Not Available
Investigational Site Number :2500005
Toulouse, 31059
FranceActive - Recruiting
Investigational Site Number : 2760002
Berlin, 13353
GermanySite Not Available
Investigational Site Number :2760002
Berlin, 13353
GermanyActive - Recruiting
Investigational Site Number : 2760004
Essen, 45147
GermanySite Not Available
Investigational Site Number :2760004
Essen, 45122
GermanyActive - Recruiting
Investigational Site Number : 2760001
Munich, 81675
GermanySite Not Available
Investigational Site Number : 2760001
München, 81675
GermanySite Not Available
Investigational Site Number :2760001
München, 81675
GermanyActive - Recruiting
Investigational Site Number : 3800004
Bologna, Emilia-Romagna 40138
ItalySite Not Available
Investigational Site Number :3800004
Bologna, Emilia-Romagna 40138
ItalyActive - Recruiting
Investigational Site Number : 3800002
Roma, Lazio 00168
ItalySite Not Available
Investigational Site Number : 3800002
Rome, Lazio 00168
ItalySite Not Available
Investigational Site Number : 3800001
Brescia, Lombardia 25123
ItalySite Not Available
Investigational Site Number :3800001
Brescia, Lombardia 25123
ItalyActive - Recruiting
Investigational Site Number : 3800003
Milan, Milano 20162
ItalySite Not Available
Investigational Site Number : 3800003
Milano, 20126
ItalySite Not Available
Investigational Site Number :3800003
Milano, 20126
ItalyActive - Recruiting
Investigational Site Number : 7240004
Barcelona, Barcelona [Barcelona] 08035
SpainSite Not Available
Investigational Site Number :7240004
Barcelona, Barcelona [Barcelona] 08035
SpainActive - Recruiting
Investigational Site Number : 7240001
Madrid, Madrid, Comunidad De 28007
SpainActive - Recruiting
Investigational Site Number : 7240002
Madrid, Madrid, Comunidad De 28046
SpainSite Not Available
Investigational Site Number : 7240003
Madrid, Madrid, Comunidad De 28041
SpainSite Not Available
Investigational Site Number :7240002
Madrid, Madrid, Comunidad De 28046
SpainActive - Recruiting
Investigational Site Number :7240003
Madrid, Madrid, Comunidad De 28041
SpainActive - Recruiting
Investigational Site Number : 7240001
Madrid / Madrid, Madrid, Comunidad De 28007
SpainSite Not Available
Investigational Site Number :7240001
Madrid / Madrid, Madrid, Comunidad De 28007
SpainActive - Recruiting
Investigational Site Number : 7520001
Huddinge, 141 57
SwedenSite Not Available
Investigational Site Number :7520001
Huddinge,
SwedenActive - Recruiting
Investigational Site Number : 7520002
Uppsala, 751 85
SwedenSite Not Available
Investigational Site Number :7520002
Uppsala, 751 85
SwedenActive - Recruiting
Cedars-Sinai Medical Center Site Number : 8400100
Los Angeles, California 90048
United StatesActive - Recruiting
Cedars-Sinai Medical Center- Site Number : 8400100
Los Angeles, California 90048
United StatesSite Not Available
University of California Los Angeles (UCLA) - Ronald Reagan UCLA Medical Center Site Number : 8400103
Los Angeles, California 90095
United StatesActive - Recruiting
University of California Los Angeles Medical Center- Site Number : 8400103
Los Angeles, California 90095
United StatesSite Not Available
University of California San Francisco - Parnassus Heights- Site Number : 8400001
San Francisco, California 94143
United StatesSite Not Available
University of California San Francisco Site Number : 8400001
San Francisco, California 94143
United StatesActive - Recruiting
Brigham & Women's Hospital Site Number : 8400004
Boston, Massachusetts 02215
United StatesActive - Recruiting
Brigham & Women's Hospital- Site Number : 8400004
Boston, Massachusetts 02115
United StatesSite Not Available
Brigham & Women's Hospital-Site Number:8400004
Boston, Massachusetts 02215
United StatesActive - Recruiting
Harvard Medical School - Massachusetts General Hospital (MGH) - Medical Practice Evaluation Center (MPEC)- Site Number : 8400007
Boston, Massachusetts 02114
United StatesActive - Recruiting
Massachusetts General Hospital Site Number : 8400007
Boston, Massachusetts 02114
United StatesActive - Recruiting
Massachusetts General Hospital- Site Number : 8400007
Boston, Massachusetts 02114
United StatesSite Not Available
Massachusetts General Hospital-Site Number:8400007
Boston, Massachusetts 02114
United StatesActive - Recruiting
NYU Langone Medical Center Site Number : 8400102
New York, New York 10016
United StatesActive - Recruiting
NYU Langone Medical Center- Site Number : 8400102
New York, New York 10016
United StatesSite Not Available
University Of Wisconsin Hospital And Clinics Site Number : 8400003
Madison, Wisconsin 53792
United StatesActive - Recruiting
University Of Wisconsin Hospital And Clinics-Site Number:8400003
Madison, Wisconsin 53792
United StatesActive - Recruiting
University of Wisconsin Hospitals and Clinics- Site Number : 8400003
Madison, Wisconsin 53792
United StatesSite Not Available
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