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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 · View on ClinicalTrials.gov ↗
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.
Conditions Studied
Interventions
- COMBINATION_PRODUCT Efgartigimod PH20 SC - prefilled syringe
- OTHER Placebo PH20 SC - prefilled syringe
Study Locations (20)
Other
- 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
Alabama
- University of Alabama at Birmingham (UAB) Hospital — Birmingham
California
- Cedars-Sinai Medical Center — Los Angeles
Illinois
- University of Chicago Medical Center — Chicago
Nebraska
- University of Nebraska Medical Center — Omaha
North Carolina
- Duke University Hospital — Durham
Ohio
- The Ohio State University Wexner Medical Center — Columbus
Virginia
- Virginia Commonwealth University (VCU) Medical Center Hume-Lee Transplant Center — Richmond
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2024-08-30 |
| Est. Completion | 2027-09 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06503731
The ClinicalTrials.gov registry entry for NCT06503731 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is argenx, which has 96 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Antibody-mediated Rejection appearing as the primary indexed condition, and to 2 interventions — of which Efgartigimod PH20 SC - prefilled syringe is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06503731 reports 20 study locations spanning 9 distinct geographic areas — top geographies include Other, Alabama, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06503731 about?
NCT06503731 is a clinical study titled "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)". 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...
What is the current status of trial NCT06503731?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2024-08-30. Estimated completion is 2027-09.
What conditions does trial NCT06503731 study?
This clinical trial studies the following conditions: Antibody-mediated Rejection. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06503731?
The interventions under investigation include: Efgartigimod PH20 SC - prefilled syringe (COMBINATION_PRODUCT), Placebo PH20 SC - prefilled syringe (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06503731?
This trial is sponsored by argenx, which has 96 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06503731 being conducted?
This trial has 20 study locations across Alabama, California, Illinois, Nebraska, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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