ARGX-117 in Deceased Donor Kidney Transplant Recipients at Risk for Delayed Graft Function
- Registration Number
- NCT05907096
- Lead Sponsor
- argenx
- Brief Summary
The main purpose of this study is to evaluate the safety, efficacy and tolerability of ARGX-117 in Deceased Donor Kidney Transplant Recipients at Risk for Delayed Graft Function.
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 102
- Is at least the local legal age of consent for clinical studies and at least aged 18 years and less than 70 years
- 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
- Any history of prothrombotic disorder or history of thrombosis or hypercoagulable state, excluding vascular access clotting
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ARGX-117 ARGX-117 Patients receiving ARGX-117 intravenous infusions Placebo Placebo Patients receiving placebo intravenous infusions
- Primary Outcome Measures
Name Time Method eGFR at 24 weeks posttransplant Up to 24 weeks Estimated glomerular filtration rate
- Secondary Outcome Measures
Name Time Method Proportion of participants with Delayed Graft Function (DGF) Up to 52 weeks Proportion of participants with fDGF (functional delayed graft function) Up to 52 weeks Duration of dialysis treatment for DGF within the first 30 days posttransplant up to 30 days Proportion of participants who have ongoing dialysis requirement at study day 31 Up to 31 days CRR at 72 hours posttransplant and on study day 8 up to 8 days Creatinine reduction ratio
iBox score at 52 weeks posttransplant up to 52 weeks Dialysis-free participant survival through 52 weeks posttransplant up to 52 weeks (Death-censored) allograft survival through 52 weeks posttransplant Up to 52 weeks eGFR at 52 weeks posttransplant up to 52 weeks Estimated glomerular filtration rate
Incidence of Primary Nonfunction (PNF) up to 12 weeks Serum concentrations for ARGX 117 up to 64 weeks Values from baseline in free C2, total C2, and CH50 up to 64 weeks Incidence of anti-drug antibodies (ADA) against ARGX-117 up to 64 weeks
Trial Locations
- Locations (45)
Hospital Universitario Miguel Servet
🇪🇸Zaragoza, Spain
Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
Columbia University
🇺🇸New York, New York, 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
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)
🇦🇹Wien, 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 das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo (HC-FMUSP)
🇧🇷Sao Paulo, Brazil
Hospital de Base
🇧🇷São Jose do Rio Preto, Brazil
Hôpital Maisonneuve-Rosemont - Centre de recherche
🇨🇦Montréal, Canada
McGill University Health Centre - Royal Victoria Hospital
🇨🇦Montréal, 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
🇫🇷Creteil, 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
🇮🇹Padova, 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
🇵🇹Lisboa, 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
Sahlgrenska Universitetssjukhuset
🇸🇪Gothenburg, Sweden
Akademiska sjukhuset
🇸🇪Uppsala, Sweden