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Clinical Trials in the USA / NCT05907096
Active, not recruiting Phase 2

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

NCT05907096 · tracked via the Priya Life Science USA tracker
Sponsor
argenx
Phase
Phase 2
Started
2024-02-17
Last updated
2026-03-18

Condition(s) studied

Delayed Graft Function

Investigational drug(s) / intervention(s)

ARGX-117Placebo

ARGX-117: Intravenous administration of ARGX-117

Placebo: Intravenous administration of placebo

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (45)

FacilityCityRegionStatus
Cedars-Sinai Medical Center Los Angeles California
Tampa General Hospital Tampa Florida
University of Illinois (UI) Health - Outpatient Care Center Chicago Illinois
Cooperman Barnabas Medical Center Livingston New Jersey
Erie County Medical Center Buffalo New York
Columbia University New York New York
The Ohio State University Columbus Ohio
University of Texas Southwestern Medical Center Dallas Texas
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

+ 5 more sites — see the full list on the official registry below.

More argenx trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05907096 on ClinicalTrials.gov ↗ ← All trials in the USA