Status:
RECRUITING
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)
Lead Sponsor:
argenx
Conditions:
Antibody-mediated Rejection
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to assess the safety, tolerability, and efficacy of efgartigimod PH20 SC given by a prefilled syringe in participants with Antibody-Mediated Rejection (AMR) after kidney t...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 30 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2027
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06503731
Start Date
August 30 2024
End Date
September 1 2027
Last Update
December 17 2025
Active Locations (22)
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1
University of Alabama at Birmingham (UAB) Hospital
Birmingham, Alabama, United States, 35233
2
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
3
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
4
Duke University Hospital
Durham, North Carolina, United States, 27705