A Study to Evaluate the Safety and Tolerability of Efgartigimod PH20 SC Given by Prefilled Syringe in Kidney Transplant Recipients With Antibody-Mediated Rejection (AMR) (Shamrock)
Actively Recruiting
About This Study
This Phase 2, global, multicenter, randomized, double-blinded, placebo-controlled trial evaluates the safety, tolerability, and efficacy of efgartigimod PH20 SC in kidney transplant recipients experiencing antibody-mediated rejection (AMR). Participants are randomized 1:1:1 to receive subcutaneous efgartigimod PH20 via prefilled syringe or placebo for a 48-week treatment period. All participants remain on standard background immunosuppression, including tacrolimus, mycophenolate mofetil, and steroids. The study monitors clinical outcomes and safety over a total duration of 78 weeks, including a 24-week observational follow-up period. The primary objective is to determine if neonatal Fc receptor (FcRn) inhibition effectively manages AMR in this patient population.
Who Can Participate?
✓ Inclusion Criteria
- •The participant is within the ages of 18 and 80 years old
- •The participant had a kidney transplant (living or deceased donor) at least 6 months before the study
- •The participant has received a diagnosis of active or chronic active antibody-mediated rejection (AMR) with detectable donor-specific antibodies at time of the study
- •A participant may be allowed into the study if they receive the following medications:
- •Received mycophenolate mofetil for at least 20 weeks before the study
- •Has remained on a stable dose of mycophenolate mofetil and tacrolimus for at least 4 weeks before being allowed to participate in the study
- •Has remained on tacrolimus doses between 5 to 10 ng/mL at least 4 weeks before being allowed to participate in the study
- •Steroid dose was between 0 to 10 mg per day of prednisone (or dose equivalent) for at least 4 weeks before being allowed to participate in the study
✗ Exclusion Criteria
- •Confirmed T-cell or mixed rejection at time of the study
- •Recent change in immunosuppressive therapy agents
- •Any other medical condition that, in the investigator's opinion, would interfere with the results of the study or put the participant at undue risk
- •Pregnant or lactating state or intention to become pregnant during the study The complete list of criteria can be found in the protocol