Antibody-mediated rejection in adult kidney transplant recipients MedDRA version: 21.1 Level: LLT Classification code 10064683 Term: Antibody-mediated rejection System Organ Class: 100000004870
Conditions
Interventions
Product Code: BIVV020
Pharmaceutical Form: Solution for injection/infusion
INN or Proposed INN: Not assigned
Current Sponsor code: BIVV020
Other descriptive name: BIVV020
Concentration unit: mg/ml mil
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 to whom they are sensitized, and/or required desensitization prior to transplantation. 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 52 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 52 weeks after the last administration of IMP (BIVV020 + SOC arm participant) or last treatment period visit (SOC arm participant). - 18-75 years old at the time of consent. 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 infection requiring antibiotic treatment against an identified or suspected bacterial pathogen. - 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: • Cohort A: To evaluate the efficacy of BIVV020 in prevention of AMR • Cohort B: To evaluate the efficacy of BIVV020 in treatment of 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 at the time of the 13, 25 and 49 week visits. | — |
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 5) Graft survival as predicted by iBOX 6) Assessment of adverse events (AEs) Number of participants with adverse events (AEs) 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 Percent 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
France, Germany, Italy, Spain, Sweden
Contacts
Public ContactUnidad de Estudios Clínicos
Sanofi-Aventis, S.A
Outcome results
None listed