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: PTClassification code 10044439Term: Transplant rejectionSystem Organ Class: 10021428 - Immune system disorders
Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Registration Number: EUCTR2021-000010-41-DE

Lead Sponsor: Sanofi-Aventis Recherche & Développement

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 45

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).
- 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
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.