Efgartigimod for Antibody-Mediated Rejection (Shamrock Trial)

Phase 2

Recruiting

Research Sponsored by argenx

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participant is within the ages of 18 and 80 years old

Participant has received a diagnosis of active or chronic active antibody-mediated rejection (AMR) with detectable donor-specific antibodies at time of the study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Summary

"This trial aims to test the safety and effectiveness of a drug called efgartigimod PH20 SC in people who have Antibody-Mediated Rejection after a kidney transplant. Participants will

Who is the study for?

This trial is for kidney transplant recipients aged 18-80 with Antibody-Mediated Rejection (AMR) who have had their transplant at least 6 months ago. Participants must be on stable doses of mycophenolate mofetil and tacrolimus, with a low steroid dose for specific periods before the study.

What is being tested?

The trial tests Efgartigimod PH20 SC's safety and effectiveness against AMR in kidney transplant patients. It compares efgartigimod to a placebo, both given by prefilled syringe alongside standard immunosuppression drugs over a treatment period of 48 weeks followed by observation.

What are the potential side effects?

While not specified here, potential side effects may include reactions at the injection site, changes in immune response due to altered antibody levels, or interactions with existing medications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 80 years old.

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I have been diagnosed with active or chronic active AMR and have detectable donor-specific antibodies.

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My tacrolimus dose has been stable between 5 to 10 ng/mL for at least 4 weeks.

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I have been taking a low dose of steroids, up to 10 mg of prednisone daily, for at least 4 weeks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Treatment arm 2Experimental Treatment2 Interventions

Participants receiving Efgartigimod PH20 SC on top of optimized standard background immunosuppression therapy (tacrolimus, mycophenolate mofetil, and optionally steroids) up to week 24 followed by placebo PH20 SC on top of optimized standard background immunosuppression therapy from weeks 24 to 48

Group II: Treatment arm 1Experimental Treatment1 Intervention

Participants receiving Efgartigimod PH20 SC on top of optimized standard background immunosuppression therapy (tacrolimus, mycophenolate mofetil, and optionally steroids)

Group III: Treatment arm 3Placebo Group1 Intervention

Participants receiving Placebo PH20 SC on top of optimized standard background immunosuppression therapy (tacrolimus, mycophenolate mofetil, and optionally steroids)

0 / 4Eligibility criteria met