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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05156710
Registration number
NCT05156710
Ethics application status
Date submitted
18/11/2021
Date registered
14/12/2021
Date last updated
15/12/2023
Titles & IDs
Public title
BIVV020 (SAR445088) n Prevention and Treatment of Antibody-mediated Rejection (AMR)
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Scientific title
A Multi-cohort, Randomized, Phase 2, Open-label Study to Assess the Preliminary Efficacy, Safety, and Pharmacokinetics of BIVV020 for Prevention and Treatment of Antibody-mediated Rejection in Adult Kidney Transplant Recipients.
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Secondary ID [1]
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U1111-1267-2612
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Secondary ID [2]
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ACT17012
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Transplant Rejection
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - BIVV020 (SAR445088)
Treatment: Drugs - Intravenous immunoglobulin (IVIg)
Treatment: Drugs - Rituximab or biosimilar
Treatment: Drugs - Antithymocyte globulin (ATG)
Treatment: Drugs - Tacrolimus
Treatment: Drugs - Mycophenolate
Treatment: Drugs - Corticosteroids
Experimental: BIVV020 with Standard of Care (SOC) Cohort A - Eligible participants will receive BIVV020 and SOC immunosuppression including induction therapy, tacrolimus, and mycophenolate.
Experimental: BIVV020 with Standard of Care (SOC) Cohort B - Eligible participants will receive BIVV020 and SOC which includes plasmapheresis, IVIg, corticosteroids, rituximab.
Other: Standard of Care (SOC) Cohort B - SOC includes plasmapheresis, IVIg, corticosteroids, rituximab.
Treatment: Drugs: BIVV020 (SAR445088)
Pharmaceutical Form: Solution for injection Route of Administration: Intravenous
Treatment: Drugs: Intravenous immunoglobulin (IVIg)
Pharmaceutical Form: Solution for injection Route of Administration: Intravenous
Treatment: Drugs: Rituximab or biosimilar
Pharmaceutical Form: Solution for injection Route of Administration: Intravenous
Treatment: Drugs: Antithymocyte globulin (ATG)
Pharmaceutical Form: Solution for injection Route of Administration: Intravenous
Treatment: Drugs: Tacrolimus
Pharmaceutical Form: Tablet Route of Administration: Oral
Treatment: Drugs: Mycophenolate
Pharmaceutical Form: Tablet Route of Administration: Oral
Treatment: Drugs: Corticosteroids
Pharmaceutical Form: Vary Route of Administration: Vary
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Cohort A: Treatment failure rate
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Assessment method [1]
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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.
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Timepoint [1]
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Up to Week 49
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Primary outcome [2]
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Cohort B: AMR resolution rate
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Assessment method [2]
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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.
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Timepoint [2]
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Up to Week 49
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Secondary outcome [1]
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Cohort A: Treatment failure rate per local assessment using Banff criteria 2019
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Assessment method [1]
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Timepoint [1]
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Up to Week 49
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Secondary outcome [2]
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Cohort B: AMR resolution rate per local assessment using Banff criteria 2019
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Assessment method [2]
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Timepoint [2]
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Up to Week 49
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Secondary outcome [3]
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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)
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Assessment method [3]
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Timepoint [3]
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Up to 22 weeks after end of treatment period
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Secondary outcome [4]
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Change in renal function from baseline per central laboratory assessment using protein: creatinine ratio
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Assessment method [4]
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Timepoint [4]
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Up to 22 weeks after end of treatment period
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Secondary outcome [5]
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Change in allograft histopathology Banff score
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Assessment method [5]
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Timepoint [5]
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Up to Week 49
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Secondary outcome [6]
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Graft survival as predicted by iBOX
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Assessment method [6]
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Timepoint [6]
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Up to Week 49
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Secondary outcome [7]
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Assessment of adverse events (AEs)
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Assessment method [7]
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Number of participants with treatment emergent adverse events (TEAEs)/ serious adverse events (SAES), laboratory abnormalities
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Timepoint [7]
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Up to end of study, up to approximately 2 years
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Secondary outcome [8]
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Change in systemic lupus erythematosus (SLE) panel
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Assessment method [8]
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Timepoint [8]
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Up to 22 weeks after end of treatment period
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Secondary outcome [9]
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Plasma exposure of BIVV020 assessing pharmacokinetic parameter Cmin
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Assessment method [9]
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Cmin is defined as the minimum concentration after injection
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Timepoint [9]
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Up to 22 weeks after end of treatment period
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Secondary outcome [10]
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Plasma exposure of BIVV020 assessing pharmacokinetic parameter AUC
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Assessment method [10]
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AUC is defined as the area under plasma concentration versus time curve
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Timepoint [10]
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Up to 22 weeks after end of treatment period
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Secondary outcome [11]
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Number of participants with anti-BIVV020 antibodies
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Assessment method [11]
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Number of participants developed drug-induced ADAs
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Timepoint [11]
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Up to 22 weeks after end of treatment period
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Eligibility
Key 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 weeks
after the last administration of IMP (BIVV020 + SOC arm participant) or last treatment
period visit (SOC arm participant).
- Contraceptive use by men during the treatment period, and for at least 49 weeks after
the last administration of IMP (BIVV020 + SOC arm participant) or last treatment
period visit (SOC arm participant).
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Participants who are ABO incompatible with their donors.
- Participants with known active ongoing infection as per below:
1. Positive HIV.
2. Positive HBV.
3. HCV with detectable HCV RNA.
4. Within 4 weeks of first study intervention: any serious infection, or any active
bacterial infection, or any other infection which is clinically significant in
the option of the Investigator, unless it can be confirmed that infection 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 study
treatment 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
9/06/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
3/12/2026
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Actual
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Sample size
Target
45
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Investigational Site Number : 0360003 - Westmead
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Recruitment postcode(s) [1]
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2145 - Westmead
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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United States of America
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State/province [2]
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Massachusetts
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United States of America
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State/province [3]
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New York
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Country [4]
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United States of America
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State/province [4]
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Wisconsin
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Country [5]
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Canada
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State/province [5]
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British Columbia
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Country [6]
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Canada
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State/province [6]
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Quebec
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Country [7]
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France
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State/province [7]
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Bordeaux
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Country [8]
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France
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State/province [8]
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Creteil
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Country [9]
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France
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State/province [9]
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Paris
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Country [10]
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France
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State/province [10]
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Suresnes
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France
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State/province [11]
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Toulouse
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Germany
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State/province [12]
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Berlin
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Germany
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State/province [13]
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Essen
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Germany
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State/province [14]
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München
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Italy
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State/province [15]
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Emilia-Romagna
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Italy
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State/province [16]
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Lazio
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Italy
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State/province [17]
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Lombardia
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Italy
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State/province [18]
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Milano
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Country [19]
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Spain
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State/province [19]
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Barcelona [Barcelona]
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Country [20]
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Spain
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State/province [20]
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Madrid, Comunidad De
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Country [21]
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Spain
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State/province [21]
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Madrid
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Sweden
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State/province [22]
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Huddinge
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Country [23]
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Sweden
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State/province [23]
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Uppsala
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Sanofi
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
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
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05156710
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Trial Transparency email recommended (Toll free number for US & Canada)
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Address
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Country
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Phone
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800-633-1610
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05156710
Download to PDF