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)

NCT06503731 | Recruiting Phase 2 FDA Drug

• 2 other identifiers: ARGX-113-23022023-508180-72-00
• Study Type: interventional
• Target: 30
• Locations: 8 countries
• Sites: 23

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.

Conditions

Antibody-mediated Rejection

Keywords

Active AMR; Chronic active AMR; Late AMR

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• Changes from baseline (slope) of the estimated glomerular filtration rate (eGFR)

  Up to 72 weeks

• Histological changes in kidney biopsy

  Up to 72 weeks

• Urine protein creatinine ratio (UPCR)

  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

Study Arms (3)

Treatment arm 1

EXPERIMENTAL

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

Combination Product: Efgartigimod PH20 SC - prefilled syringe

Treatment arm 2

EXPERIMENTAL

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

Combination Product: Efgartigimod PH20 SC - prefilled syringe; Other: Placebo PH20 SC - prefilled syringe

Treatment arm 3

PLACEBO COMPARATOR

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

Other: Placebo PH20 SC - prefilled syringe

Interventions

Efgartigimod PH20 SC - prefilled syringe COMBINATION_PRODUCT

Subcutaneous efgartigimod PH20 SC given by prefilled syringe

Treatment arm 1; Treatment arm 2

Placebo PH20 SC - prefilled syringe OTHER

Subcutaneous placebo PH20 SC given by prefilled syringe

Treatment arm 2; Treatment arm 3

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 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

You may not qualify if:

• 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

Sponsors & Collaborators

• argenx: lead

Study Sites (23)

University of Alabama at Birmingham (UAB) Hospital

Birmingham, Alabama, 35233, United States

RECRUITING

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

RECRUITING

University of Chicago Medical Center

Chicago, Illinois, 60615, United States

RECRUITING

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

RECRUITING

Duke University Hospital

Durham, North Carolina, 27705, United States

RECRUITING

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

RECRUITING

Virginia Commonwealth University (VCU) Medical Center Hume-Lee Transplant Center

Richmond, Virginia, 23298, United States

RECRUITING

University of Washington Medical Center

Seattle, Washington, 98195, United States

RECRUITING

Allgemeines Krankenhaus der Stadt Wien (AKH Wien) - Medizinischer Universitätscampus

Vienna, 1090, Austria

RECRUITING

Universitair Ziekenhuis (UZ) Gent

Ghent, 9000, Belgium

RECRUITING

Universitair Ziekenhuis Leuven (UZ Leuven) - Campus Gasthuisberg

Leuven, 3000, Belgium

RECRUITING

London Health Sciences Centre

London, N6A 5A5, Canada

RECRUITING

Institut klinicke a experimentalni mediciny (IKEM)

Prague, 140-21, Czechia

RECRUITING

Centre Hospitalier Universitaire (CHU) de Bordeaux - Hôpital Pellegrin

Bordeaux, 33076, France

RECRUITING

Centre Hospitalier Universitaire (CHU) de Grenoble Alpes - Hôpital Michallon

La Tronche, 38700, France

RECRUITING

Centre Hospitalier Universitaire (CHU) de Toulouse - Hôpital de Rangueil

Toulouse, 31059, France

RECRUITING

Charité - Universitätsmedizin Berlin

Berlin, 13353, Germany

RECRUITING

Universitaetsklinikum Carl Gustav Carus Dresden

Dresden, 01307, Germany

RECRUITING

Universitätsklinikum Hamburg-Eppendorf

Hamburg, 20246, Germany

RECRUITING

Hospital Del Mar

Barcelona, 08003, Spain

RECRUITING

Hospital Universitario Vall d'Hebron

Barcelona, 08035, Spain

RECRUITING

Hospital Universitario de Bellvitge

Barcelona, 08907, Spain

RECRUITING

Hospital Universitario Miguel Servet

Zaragoza, 50009, Spain

RECRUITING

Central Study Contacts

Sabine Coppieters, MD

CONTACT

857-350-4834; clinicaltrials@argenx.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2024
• First Posted: July 16, 2024
• Study Start: August 30, 2024
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (4); CA (1); AU (1); DE (3); BE (2); US (8); CZ (1); FR (3)