Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Sanofi
Up to approximately 2 years
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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).
You may not be if
Participants who are ABO incompatible with their donors.
Participants with known active ongoing infection as per below:
1. Positive HIV.
2. Positive HBV.
3. HCV with detectable HCV RNA.
4. 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 option 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.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
