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Efgartigimod PH20 SC for Antibody-Mediated Rejection After Kidney Transplant

This study is looking at a new treatment called efgartigimod PH20 SC, given by a prefilled syringe, for people who have antibody-mediated rejection (AMR) after a kidney transplant. AMR is when your body's immune system attacks the transplanted kidney. The main goal of this study is to see how safe and tolerable efgartigimod PH20 SC is. Researchers will also look at how well it works. You might be able to join if you are 18 to 80 years old, had a kidney transplant at least 6 months ago, and have been diagnosed with active or chronic active AMR with specific antibodies. The study is currently unclear about its recruitment status.

Study design
This study plans to enroll 33 participants and will compare efgartigimod PH20 SC to a placebo (an inactive substance) in a randomized way. Participants will be randomized in a 1:1:1 ratio.
What's involved
After a screening period of up to 6 weeks, you would receive the study drug or placebo subcutaneously (under the skin) for 48 weeks while continuing your standard immunosuppression therapy. You will be in the study for up to 78 weeks.
Compensation
Not stated in the trial record.
Follow-up
Participants will have an observational/follow-up period of approximately 24 weeks after the 48-week treatment period, for a total study duration of up to 78 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06503731

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)

Active, Not Recruiting
PHASE2Ages 18–80InterventionalTreatment
argenx
~33 participants
Updated 2026-07-02 on ClinicalTrials.gov
What's tested:Efgartigimod PH20 SC - prefilled syringePlacebo PH20 SC - prefilled syringe

At a glance

Recruiting sites
0 of 23 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of Adverse Events (AEs)
Measured over Up to 78 weeks
+1 more outcome measured

Conditions

Antibody-mediated Rejection

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Where it's being run

23 sites across 15 states
Spain4
France3
Germany3
Belgium2
Alabama1
California1
Illinois1
Nebraska1

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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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:

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

What this trial measures

  • Incidence of Adverse Events (AEs)Up to 78 weeks
  • Percentage of participants with permanent treatment discontinuation due to adverse events (AEs)Up to 48 weeks