ARGX-117 in Deceased Donor Kidney Transplant Recipients at Risk for Delayed Graft Function
NCT ID: NCT05907096
Last Updated: 2025-06-20
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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ACTIVE_NOT_RECRUITING
PHASE2
103 participants
INTERVENTIONAL
2024-02-17
2026-07-31
Brief Summary
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The study consists of 2 parts: part A comprises the main study period, and part B comprises the long-term observational follow-up period. During part A, after the screening period, eligible participants will be randomized to receive either ARGX-117 or placebo, entering the treatment and evaluation period (duration of up to 52 weeks). After the treatment period, participants will enter a follow-up period of up to 12 weeks.
The total study duration varies from approximately 64 weeks up to 5 years post-transplant depending on whether a participant enrols in part B of the study.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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ARGX-117
Patients receiving ARGX-117 intravenous infusions
ARGX-117
Intravenous administration of ARGX-117
Placebo
Patients receiving placebo intravenous infusions
Placebo
Intravenous administration of placebo
Interventions
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ARGX-117
Intravenous administration of ARGX-117
Placebo
Intravenous administration of placebo
Eligibility Criteria
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Inclusion Criteria
* Agree to use contraceptive measures consistent with local regulations
* Are diagnosed with ESRD and have been stable on chronic dialysis for at least 3 months
* Are recipients of de novo or second-time, single kidney transplant from a deceased donor, either DCD (donation after cardiac/circulatory death) or DBD ( (donation after brain death)
* Are ABO compatible with donor allograft, except for type A2 donor to type B recipient kidneys
* Have a negative cross match
* Have received pretransplant vaccinations for: Neisseria meningitidis, Streptococcus pneumoniae, and Haemophilus influenzae, or are willing to receive the vaccinations approximately 3 to 4 months posttransplant
Exclusion Criteria
* Any known history of complement deficiency
* Evidence of peritonitis in participants on peritoneal dialysis
* Received any solid organ, bone marrow, or hematopoietic stem cell transplant, with the exception of prior first kidney transplant
* High risk within the study period for recurrence of underlying renal disease in the opinion of the investigator
* Clinically significant comorbidity, recent major surgery (within 3 months of screening), history of any treatment nonadherence, or intention to have surgery during the study other than kidney transplantation; or any other medical condition that, in the investigator's opinion, would confound the results of the study or put the participant at undue risk
* Clinically significant active bacterial, viral, or fungal infection
* History of malignancy unless considered cured by adequate treatment, with no evidence of recurrence for 5 years or more before first study drug administration. Adequately treated participants with the following cancers can be included at any time: Basal cell or squamous cell skin cancer; Carcinoma in situ of the cervix; Carcinoma in situ of the breast; Incidental histological finding of prostate cancer
* History of current alcohol, drug, or medication abuse as assessed by the investigator
* Pregnant or lactating state or intention to become pregnant during the study
The full list of criteria can be found in the protocol.
18 Years
70 Years
ALL
No
Sponsors
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argenx
INDUSTRY
Responsible Party
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Locations
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Cedars-Sinai Medical Center
Los Angeles, California, United States
Tampa General Hospital
Tampa, Florida, United States
University of Illinois (UI) Health - Outpatient Care Center
Chicago, Illinois, United States
Cooperman Barnabas Medical Center
Livingston, New Jersey, United States
Erie County Medical Center
Buffalo, New York, United States
Columbia University
New York, New York, United States
The Ohio State University
Columbus, Ohio, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Royal Adelaide Hospital
Adelaide, , Australia
Monash Health - Monash Medical Centre
Clayton, , Australia
Princess Alexandra Hospital
Woolloongabba, , Australia
Tirol Kliniken - A.o. Landeskrankenhaus Innsbruck
Innsbruck, , Austria
Allgemeines Krankenhaus der Stadt Wien (AKH Wien)
Vienna, , Austria
Universitair Ziekenhuis Leuven
Leuven, , Belgium
Centro Hospitalar e Universitario de Coimbra
Coimbra, , Brazil
Hospital Geral de Fortaleza
Fortaleza, , Brazil
Santa Casa de Misericordia de Porto Alegre - Hospital Dom Vicente Scherer
Porto Alegre, , Brazil
Hospital de Base
São Jose Do Rio Preto, , Brazil
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo (HC-FMUSP)
São Paulo, , Brazil
Hôpital Maisonneuve-Rosemont - Centre de recherche
Montreal, , Canada
McGill University Health Centre - Royal Victoria Hospital
Montreal, , Canada
Vancouver Coastal Health - Vancouver General Hospital Diamond Healthcare Centre
Vancouver, , Canada
Providence Health Care - St. Pauls Hospital
Vancouver, , Canada
CHU Bordeaux - Groupe Hospitalier Pellegrin
Bordeaux, , France
Assistance Publique Hopitaux de Paris (AP-HP) - Hopital Henri Mondor
Créteil, , France
CHU Grenoble Alpes - Hopital Michallon
La Tronche, , France
Assistance Publique Hopitaux de Paris (AP-HP) - Hopital Necker-Enfants Malades
Paris, , France
CHU de Toulouse - Hopital Rangueil
Toulouse, , France
CHRU de Tours - Hopital Bretonneau
Tours, , France
Azienda Ospedaliero Universitaria di Bologna Policlinico di Sant'Orsola
Bologna, , Italy
Azienda Ospedale Universita Padova
Padua, , Italy
Azienda Ospedaliero Universitaria Citta della Salute e della Scienza di Torino - Presidio Molinette
Torino, , Italy
Centro Hospitalar de Lisboa Ocidental EPE - Hospital de Santa Cruz
Carnaxide, , Portugal
Centro Hospitalar Universitario Lisboa Central EPE - Hospital Curry Cabral
Lisbon, , Portugal
Centro Hospitalar Universitario de Santo Antonio
Porto, , Portugal
Hospital Universitari Germans Trias i Pujol (HUGTP)
Badalona, , Spain
Hospital del Mar
Barcelona, , Spain
Fundacio Puigvert
Barcelona, , Spain
Hospital Universitario Vall d'Hebron
Barcelona, , Spain
Hospital Universitario Virgen de las Nieves - Hospital General
Granada, , Spain
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, , Spain
Hospital Universitari Doctor Peset
Valencia, , Spain
Hospital Universitario Miguel Servet
Zaragoza, , Spain
Sahlgrenska Universitetssjukhuset
Gothenburg, , Sweden
Akademiska sjukhuset
Uppsala, , Sweden
Countries
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Other Identifiers
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2022-503091-89-00
Identifier Type: OTHER
Identifier Source: secondary_id
ARGX-117-2201
Identifier Type: -
Identifier Source: org_study_id
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