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)
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
argenx
Age
18–80
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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:
1. Received mycophenolate mofetil for at least 20 weeks before the study
2. Has remained on a stable dose of mycophenolate mofetil and tacrolimus for at least 4 weeks before being allowed to participate in the study
3. Has remained on tacrolimus doses between 5 to 10 ng/mL at least 4 weeks before being allowed to participate in the study
4. 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
You may not be if
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
Clareo Health | 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)
