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)

Phase 2

Recruiting

• Conditions: Antibody-mediated Rejection

• Registration Number: NCT06503731
• Lead Sponsor: argenx

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 transplantation.

After a screening period of up to 6 weeks, eligible participants will be randomized in a 1:1:1 ratio. The study drug will be administered subcutaneously while patients remain on their standard background immunosuppression therapy (tacrolimus, mycophenolate mofetil, steroids) during the treatment period (48 weeks). At the end of the treatment period, the participants will enter an observational/follow-up period (approximately 24 weeks). The participants will be in the study for up to 78 weeks.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-07-10
• Study First Submitted QC: 2024-07-10
• Study First Posted: 2024-07-16
• Study Start: 2024-08-30
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-12
• Last Update Posted: 2025-06-15
• Primary Completion: 2027-09
• Study Completion: 2027-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Incidence of antidrug antibodies (ADA) against efgartigimod in serum over time	Up to 72 weeks
Changes from baseline (slope) of the estimated glomerular filtration rate (eGFR)	Up to 72 weeks
Urine protein creatinine ratio (UPCR)	Up to 72 weeks
Histological changes in kidney biopsy	Up to 72 weeks
Incidence of antibodies against rHuPH20 in plasma over time	Up to 72 weeks
Graft and participant survival	Up to 72 weeks
Percentage change from baseline in total IgG levels in serum over time	Up to 60 weeks
Efgartigimod serum concentration-time profile and PK parameter Ctrough	Up to 48 weeks

Trial Locations

Locations (16)

Cedars-Sinai Medical Center; 🇺🇸 Los Angeles, California, United States

Universitair Ziekenhuis (UZ) Gent; 🇧🇪 Gent, Belgium

Universitätsklinikum Hamburg-Eppendorf; 🇩🇪 Hamburg, Germany

University of Alabama at Birmingham (UAB) Hospital; 🇺🇸 Birmingham, Alabama, United States

Duke University Hospital; 🇺🇸 Durham, North Carolina, United States

The Ohio State University Wexner Medical Center; 🇺🇸 Columbus, Ohio, United States

Virginia Commonwealth University (VCU) Medical Center Hume-Lee Transplant Center; 🇺🇸 Richmond, Virginia, United States

University of Washington Medical Center; 🇺🇸 Seattle, Washington, United States

Allgemeines Krankenhaus der Stadt Wien (AKH Wien) - Medizinischer Universitätscampus; 🇦🇹 Wien, Austria

Universitair Ziekenhuis Leuven (UZ Leuven) - Campus Gasthuisberg; 🇧🇪 Leuven, Belgium

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