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ACTIVE NOT RECRUITING

NCT05907096

PHASE2

ARGX-117 in Deceased Donor Kidney Transplant Recipients at Risk for Delayed Graft Function

Sponsor: argenx

View on ClinicalTrials.gov

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.

Official title: A Phase 2, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Study to Assess the Safety, Efficacy, and Tolerability of ARGX-117 in Improving Allograft Function in Recipients of a Deceased Donor Renal Allograft at Risk for Delayed Graft Function

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

103

Start Date

2024-02-17

Completion Date

2026-07-31

Last Updated

2026-03-18

Healthy Volunteers

Conditions

Delayed Graft Function

Interventions

BIOLOGICAL

ARGX-117

Intravenous administration of ARGX-117

OTHER

Placebo

Intravenous administration of placebo

Inclusion Criteria: * 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 Exclusion Criteria: * 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.

Locations (45)

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

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

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

Clinical Research Directory

ARGX-117 in Deceased Donor Kidney Transplant Recipients at Risk for Delayed Graft Function

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (45)