Evaluating a new treatment for kidney transplant rejection
A Global, Multicenter, Randomized, Double-Blinded, Placebo-Controlled, Phase 2 Study to Evaluate the Safety, Tolerability, and Efficacy of Efgartigimod PH20 SC Administered by a Prefilled Syringe in Kidney Transplant Recipients With Antibody-Mediated Rejection
This study is testing a new treatment for kidney transplant rejection to see if it helps patients with this condition feel better while they continue their usual medications.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | argenx Industry-sponsored |
| Drugs / interventions | prednisone |
| Locations | 23 sites (Birmingham, Alabama and 22 other locations) |
| Trial ID | NCT06503731 on ClinicalTrials.gov |
What this trial studies
This study assesses the safety, tolerability, and efficacy of efgartigimod PH20 SC administered via prefilled syringe in kidney transplant recipients experiencing antibody-mediated rejection (AMR). Participants will be randomized to receive either the study drug or a placebo while continuing their standard immunosuppressive therapy over a treatment period of 48 weeks, followed by a 24-week observational phase. The study aims to determine how well the treatment works in managing AMR in these patients.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 who have undergone a kidney transplant at least 6 months prior and have a diagnosis of active or chronic active AMR.
Not a fit: Patients with confirmed T-cell or mixed rejection will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve outcomes for kidney transplant recipients suffering from antibody-mediated rejection.
How similar studies have performed: Other studies have shown promise in treating antibody-mediated rejection, but this specific approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Birmingham, Alabama and 22 other locations
- University of Alabama at Birmingham (UAB) Hospital — Birmingham, Alabama, United States (Recruiting)
- Cedars-Sinai Medical Center — Los Angeles, California, United States (Recruiting)
- University of Chicago Medical Center — Chicago, Illinois, United States (Recruiting)
- University of Nebraska Medical Center — Omaha, Nebraska, United States (Recruiting)
- Duke University Hospital — Durham, North Carolina, United States (Recruiting)
- The Ohio State University Wexner Medical Center — Columbus, Ohio, United States (Recruiting)
- Virginia Commonwealth University (VCU) Medical Center Hume-Lee Transplant Center — Richmond, Virginia, United States (Recruiting)
- University of Washington Medical Center — Seattle, Washington, United States (Recruiting)
- Allgemeines Krankenhaus der Stadt Wien (AKH Wien) - Medizinischer Universitätscampus — Vienna, Austria (Recruiting)
- Universitair Ziekenhuis (UZ) Gent — Ghent, Belgium (Recruiting)
- Universitair Ziekenhuis Leuven (UZ Leuven) - Campus Gasthuisberg — Leuven, Belgium (Recruiting)
- London Health Sciences Centre — London, Canada (Recruiting)
- Institut klinicke a experimentalni mediciny (IKEM) — Prague, Czechia (Recruiting)
- Centre Hospitalier Universitaire (CHU) de Bordeaux - Hôpital Pellegrin — Bordeaux, France (Recruiting)
- Centre Hospitalier Universitaire (CHU) de Grenoble Alpes - Hôpital Michallon — La Tronche, France (Recruiting)
- Centre Hospitalier Universitaire (CHU) de Toulouse - Hôpital de Rangueil — Toulouse, France (Recruiting)
- Charité - Universitätsmedizin Berlin — Berlin, Germany (Recruiting)
- Universitaetsklinikum Carl Gustav Carus Dresden — Dresden, Germany (Recruiting)
- Universitätsklinikum Hamburg-Eppendorf — Hamburg, Germany (Recruiting)
- Hospital Del Mar — Barcelona, Spain (Recruiting)
- Hospital Universitario Vall d'Hebron — Barcelona, Spain (Recruiting)
- Hospital Universitario de Bellvitge — Barcelona, Spain (Recruiting)
- Hospital Universitario Miguel Servet — Zaragoza, Spain (Recruiting)
Study contacts
- Study coordinator: Sabine Coppieters, MD
- Email: clinicaltrials@argenx.com
- Phone: 857-350-4834
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.