ARGX-117 in Deceased Donor Kidney Transplant Recipients at Risk for Delayed Graft Function
Condition(s) studied
Investigational drug(s) / intervention(s)
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
Primary outcome measure(s)
- eGFR at 24 weeks posttransplant — Up to 24 weeks
Estimated glomerular filtration rate
Trial sites (45)
| Facility | City | Region | Status |
|---|---|---|---|
| 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
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