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NCT06503731 · ClinicalTrials.gov registry record · 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)
A Phase 2 study of Antibody-mediated Rejection, sponsored by argenx.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
- 20
- Study locations
NCT06503731: Recruiting Phase 2 study of Antibody-mediated Rejection, sponsored by argenx.
NCT06503731 is a Phase 2 study of Antibody-mediated Rejection that is actively recruiting participants, run by argenx. The registered enrollment target is 30 participants, below the 166-participant average among 5 other Antibody-mediated Rejection trials with a reported enrollment target (82% lower). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06503731, a Phase 2 study of Antibody-mediated Rejection, is actively recruiting participants, sponsored by argenx.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
- 20
- Study locations
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 |
What NCT06503731 shows while recruiting
NCT06503731 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 166-participant average among 5 other Antibody-mediated Rejection trials with a reported enrollment target (82% lower).
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.
NCT06503731 names 20 study sites across 9 states, led by Other, Alabama, California.
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.
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).
Who is sponsoring clinical trial NCT06503731?
This trial is sponsored by argenx, which has 49 total clinical trials registered on ClinicalTrials.gov.
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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