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A Phase 2 study to Evaluate the Safety, Tolerability and Efficacy of Efgartigimod PH20 SC given by prefilled syringe in Kidney Transplant Recipients With Antibody-Mediated Rejection
EU CTIS ID: 2023-508180-72-00
What this study is testing
To evaluate the safety and tolerability of efgartigimod PH20 SC in kidney transplant recipients diagnosed with antibody-mediated rejection (AMR)
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join 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 screening
- The participant has received a diagnosis of active or chronic active antibody-mediated rejection (AMR) with detectable donor-specific antibodies at time of screening
- A participant may be allowed into the study if they receive the following medications: a) Received mycophenolate mofetil (MMF) for ≥20 weeks before screening b) Has remained on a stable dose of mycophenolate mofetil (MMF) + tacrolimus (TAC) for ≥4 weeks before being allowed to participate in the study c) Has remained on tacrolimus (TAC) doses between 5 to 10 ng/mL ≥4 weeks before being allowed to participate in the study d) Steroid dose was between 0 to 10 mg per day of prednisone (or dose equivalent) for ≥4 weeks before being allowed to participate in the study
You likely can't join if
- Confirmed T-cell or mixed rejection at time of screening
- Recent change in immunosuppressive therapy agents (more information is found in the protocol)
- 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 study team makes the final eligibility decision.
Where it's taking place
- Canada
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Canada; United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.