BIVV020 in prevention and treatment of antibody-mediated rejection (AMR)

Phase 1

• Conditions: Antibody-mediated rejection in adult kidney transplant recipients; MedDRA version: 21.1Level: LLTClassification code 10064683Term: Antibody-mediated rejectionSystem Organ Class: 100000004870; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2021-000010-41-IT
• Lead Sponsor: SANOFI-AVENTIS RECHERCHE E DEVELOPPEMENT

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-09-14
• Last Update Posted: 2 March 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 54

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified