Primary Objectives: * Cohort A: To evaluate the efficacy of BIVV020 in prevention of AMR * Cohort B: To evaluate the efficacy of BIVV020 in treatment of active AMR Secondary Objectives: * To assess the overall efficacy of BIVV020 in prevention or treatment of AMR * To characterize the safety and tolerability of BIVV020 in kidney transplant participants * To characterize the pharmacokinetic (PK) profile of BIVV020 in kidney transplant participants * To evaluate the immunogenicity of BIVV020
Up to approximately 2 years
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
48
Pharmaceutical Form: Solution for injection Route of Administration: Intravenous
Pharmaceutical Form: Solution for injection Route of Administration: Intravenous
Pharmaceutical Form: Solution for injection Route of Administration: Intravenous
Cohort A: Treatment failure rate
Defined as the proportion of participants meeting at least one of the following criteria: * Biopsy-proven active AMR as per Banff Criteria 2019 as per central pathology assessment, * Graft loss.
Time frame: Up to Week 49
Cohort B: AMR resolution rate
Defined as the proportion of participants with post-treatment biopsy not fulfilling active AMR diagnosis criteria as per Banff Criteria 2019 as per central pathology assessment.
Time frame: Up to Week 49
Cohort A: Treatment failure rate per local assessment using Banff criteria 2019
Time frame: Up to Week 49
Cohort B: AMR resolution rate per local assessment using Banff criteria 2019
Time frame: Up to Week 49
Change in renal function from baseline per central laboratory assessment of estimated glomerular filtration rate (eGFR) from serum creatinine using Modification of Diet in Renal Disease equation (MDRD)
Time frame: Up to 22 weeks after end of treatment period
Change in renal function from baseline per central laboratory assessment using protein: creatinine ratio
Time frame: Up to 22 weeks after end of treatment period
Change in allograft histopathology Banff score
Time frame: Up to Week 49
Graft survival as predicted by iBOX
Time frame: Up to Week 49
Assessment of adverse events (AEs)
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Pharmaceutical Form: Solution for injection Route of Administration: Intravenous
Pharmaceutical Form: Tablet Route of Administration: Oral
Pharmaceutical Form: Tablet Route of Administration: Oral
Pharmaceutical Form: Vary Route of Administration: Vary
Cedars-Sinai Medical Center- Site Number : 8400100
Los Angeles, California, United States
University of California Los Angeles Medical Center- Site Number : 8400103
Los Angeles, California, United States
University of California San Francisco - Parnassus Heights- Site Number : 8400001
San Francisco, California, United States
Massachusetts General Hospital- Site Number : 8400007
Boston, Massachusetts, United States
Brigham & Women's Hospital- Site Number : 8400004
Boston, Massachusetts, United States
NYU Langone Medical Center- Site Number : 8400102
New York, New York, United States
University of Wisconsin Hospitals and Clinics- Site Number : 8400003
Madison, Wisconsin, United States
Investigational Site Number : 1240101
Vancouver, British Columbia, Canada
Investigational Site Number : 1240001
Vancouver, British Columbia, Canada
Investigational Site Number : 1240002
London, Ontario, Canada
...and 17 more locations
Number of participants with treatment emergent adverse events (TEAEs)/ serious adverse events (SAES), laboratory abnormalities
Time frame: Up to end of study, up to approximately 2 years
Change in systemic lupus erythematosus (SLE) panel
Time frame: Up to 22 weeks after end of treatment period
Plasma exposure of BIVV020 assessing pharmacokinetic parameter Cmin
Cmin is defined as the minimum concentration after injection
Time frame: Up to 22 weeks after end of treatment period
Plasma exposure of BIVV020 assessing pharmacokinetic parameter AUC
AUC is defined as the area under plasma concentration versus time curve
Time frame: Up to 22 weeks after end of treatment period
Number of participants with anti-BIVV020 antibodies
Number of participants developed drug-induced ADAs
Time frame: Up to 22 weeks after end of treatment period