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Clinical Trials in the USA / NCT06503731
Active, not recruiting Phase 2

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 · tracked via the Priya Life Science USA tracker
Sponsor
argenx
Phase
Phase 2
Started
2024-08-30
Last updated
2026-07-02

Condition(s) studied

Antibody-mediated Rejection

Investigational drug(s) / intervention(s)

Efgartigimod PH20 SC - prefilled syringePlacebo PH20 SC - prefilled syringe

Efgartigimod PH20 SC - prefilled syringe: Subcutaneous efgartigimod PH20 SC given by prefilled syringe

Placebo PH20 SC - prefilled syringe: Subcutaneous placebo PH20 SC given by prefilled syringe

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (23)

FacilityCityRegionStatus
University of Alabama at Birmingham (UAB) Hospital Birmingham Alabama
Cedars-Sinai Medical Center Los Angeles California
University of Chicago Medical Center Chicago Illinois
University of Nebraska Medical Center Omaha Nebraska
Duke University Hospital Durham North Carolina
The Ohio State University Wexner Medical Center Columbus Ohio
Virginia Commonwealth University (VCU) Medical Center Hume-Lee Transplant Center Richmond Virginia
University of Washington Medical Center Seattle Washington
Allgemeines Krankenhaus der Stadt Wien (AKH Wien) - Medizinischer Universitätscampus Vienna Austria
Universitair Ziekenhuis (UZ) Gent Ghent Belgium
Universitair Ziekenhuis Leuven (UZ Leuven) - Campus Gasthuisberg Leuven Belgium
London Health Sciences Centre London Canada
Institut klinicke a experimentalni mediciny (IKEM) Prague Czechia
Centre Hospitalier Universitaire (CHU) de Bordeaux - Hôpital Pellegrin Bordeaux France
Centre Hospitalier Universitaire (CHU) de Grenoble Alpes - Hôpital Michallon La Tronche France
Centre Hospitalier Universitaire (CHU) de Toulouse - Hôpital de Rangueil Toulouse France
Charité - Universitätsmedizin Berlin Berlin Germany
Universitaetsklinikum Carl Gustav Carus Dresden Dresden Germany
Universitätsklinikum Hamburg-Eppendorf Hamburg Germany
Hospital Del Mar Barcelona Spain
Hospital Universitario Vall d'Hebron Barcelona Spain
Hospital Universitario de Bellvitge Barcelona Spain
Hospital Universitario Miguel Servet Zaragoza Spain

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06503731 on ClinicalTrials.gov ↗ ← All trials in the USA