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-ES
• Lead Sponsor: Sanofi-Aventis Recherche & Développement

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-08-30
• Last Update Posted: 18 October 2021

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