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)
NCT ID: NCT06503731
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
30 participants
INTERVENTIONAL
2024-08-30
2027-09-30
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Treatment arm 3
Participants receiving Placebo PH20 SC on top of optimized standard background immunosuppression therapy (tacrolimus, mycophenolate mofetil, and optionally steroids)
Placebo PH20 SC - prefilled syringe
Subcutaneous placebo PH20 SC given by prefilled syringe
Treatment arm 1
Participants receiving Efgartigimod PH20 SC on top of optimized standard background immunosuppression therapy (tacrolimus, mycophenolate mofetil, and optionally steroids)
Efgartigimod PH20 SC - prefilled syringe
Subcutaneous efgartigimod PH20 SC given by prefilled syringe
Treatment arm 2
Participants receiving Efgartigimod PH20 SC on top of optimized standard background immunosuppression therapy (tacrolimus, mycophenolate mofetil, and optionally steroids) up to week 24 followed by placebo PH20 SC on top of optimized standard background immunosuppression therapy from weeks 24 to 48
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
80 Years
ALL
No
Sponsors
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argenx
INDUSTRY
Responsible Party
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Locations
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University of Alabama at Birmingham (UAB) Hospital
Birmingham, Alabama, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Duke University Hospital
Durham, North Carolina, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States
Virginia Commonwealth University (VCU) Medical Center Hume-Lee Transplant Center
Richmond, Virginia, United States
University of Washington Medical Center
Seattle, Washington, United States
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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2023-508180-72-00
Identifier Type: CTIS
Identifier Source: secondary_id
ARGX-113-2302
Identifier Type: -
Identifier Source: org_study_id