Antibody-mediated rejection in adult kidney transplant recipients MedDRA version: 21.1 Level: PT Classification code 10044439 Term: Transplant rejection System Organ Class: 10021428 - Immune system disorders
Conditions
Sponsors
Sanofi-Aventis Recherche & Développement
Eligibility
Sex/Gender
All
Inclusion criteria
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). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 41 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 13
Exclusion criteria
Exclusion criteria: - Participants are excluded from the study if any of the following criteria apply: - Participants who are ABO incompatible with their donors. - Participants with known active ongoing infection as per below: a) Positive HIV. b) Positive HBV. c) HCV with detectable HCV RNA. d) 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 opinion 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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 Objective: • 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.;Primary end point(s): 1) 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. 2) 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.;Timepoint(s) of evaluation of this end point: 1)Day 1 up to 49 weeks 2) Day 1 up to 49 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) Cohort A: Treatment failure rate as per local assessment using Banff criteria 2019 2) Cohort B: AMR resolution rate as per local assessment using Banff criteria 2019 3) Change in renal function from baseline as per central laboratory assessment (eGFR MDRD, serum creatinine, protein: creatinine ratio) 4) Change in histopathology from baseline as per local assessment using Banff criteria 2019 5) Graft survival as predicted by iBOX 6) Assessment of adverse events (AEs) Number of participants with treatment emergent adverse events (TEAEs)/ serious adverse events (SEAS), laboratory anomalies 7) Change in systemic lupus erythematosus (SLE) panel 8) Plasma exposure of BIVV020 PK parameters include, but may not be limited to Cmin and AUCss 9) Number of participants with anti-BIVV020 antibodies Number of participants developed drug-induced ADAs;Timepoint(s) of evaluation of this end point: 1)-2)-4)-5) Up to 49 weeks 3)-7)-8)-9) Up to 22 weeks after end of treatment period 6) Up to end of study | — |
Countries
Australia, Canada, France, Germany, Italy, Spain, Sweden
Contacts
Public ContactClinical Study Unit
Sanofi AB
Outcome results
None listed