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)
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
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: University of Alabama at Birmingham (UAB) Hospital — Birmingham, Alabama
Age range: 18 Years to 80 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (23 Sites)
- 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,
- Universitair Ziekenhuis (UZ) Gent — Ghent,
- Universitair Ziekenhuis Leuven (UZ Leuven) - Campus Gasthuisberg — Leuven,
- London Health Sciences Centre — London,
- Institut klinicke a experimentalni mediciny (IKEM) — Prague,
- Centre Hospitalier Universitaire (CHU) de Bordeaux - Hôpital Pellegrin — Bordeaux,
- Centre Hospitalier Universitaire (CHU) de Grenoble Alpes - Hôpital Michallon — La Tronche,
- Centre Hospitalier Universitaire (CHU) de Toulouse - Hôpital de Rangueil — Toulouse,
- Charité - Universitätsmedizin Berlin — Berlin,
- Universitaetsklinikum Carl Gustav Carus Dresden — Dresden,
- Universitätsklinikum Hamburg-Eppendorf — Hamburg,
- Hospital Del Mar — Barcelona,
- Hospital Universitario Vall d'Hebron — Barcelona,
- Hospital Universitario de Bellvitge — Barcelona,
- Hospital Universitario Miguel Servet — Zaragoza,
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Antibody-mediated Rejection
- Phase 2 Study of ALXN2030 in Patients With Antibody-Mediated Rejection After Kidney Transplantation — Birmingham, Alabama
- A Study to Learn More About the Effects and Safety of Felzartamab Infusions in Adults With Kidney Transplants Who Have Antibody-Mediated Rejection (AMR) — Los Angeles, California
- Biorepository and Registry for Plasma Exchange Patients — Iowa City, Iowa
Explore by condition: All Antibody-mediated Rejection clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.