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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-503091-89-00 | Other Identifier | CTIS number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ARGX-117 | Experimental | Patients receiving ARGX-117 intravenous infusions |
|
| Placebo | Placebo Comparator | Patients receiving placebo intravenous infusions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ARGX-117 | Biological | Intravenous administration of ARGX-117 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| eGFR at 24 weeks posttransplant | Estimated glomerular filtration rate | Up to 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
The full list of criteria can be found in the protocol.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | United States | ||
| Tampa General Hospital |
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| Placebo |
| Other |
Intravenous administration of placebo |
|
| 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 | Creatinine reduction ratio | up to 8 days |
| 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 | Estimated glomerular filtration rate | up to 52 weeks |
| Incidence of PNF | Primary Nonfunction | up to 12 weeks |
| Serum concentrations for ARGX 117 | up to 64 weeks |
| Changes 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 |
| Tampa |
| Florida |
| 33606 |
| United States |
| University of Illinois (UI) Health - Outpatient Care Center | Chicago | Illinois | 60612 | United States |
| Cooperman Barnabas Medical Center | Livingston | New Jersey | 07039 | United States |
| Erie County Medical Center | Buffalo | New York | 14215 | United States |
| Columbia University | New York | New York | 10032 | United States |
| The Ohio State University | Columbus | Ohio | 43210 | United States |
| University of Texas Southwestern Medical Center | Dallas | Texas | 10267 | United States |
| Royal Adelaide Hospital | Adelaide | SA 5000 | Australia |
| Monash Health - Monash Medical Centre | Clayton | 3168 | Australia |
| Princess Alexandra Hospital | Woolloongabba | QLD 4102 | Australia |
| Tirol Kliniken - A.o. Landeskrankenhaus Innsbruck | Innsbruck | 6020 | Austria |
| Allgemeines Krankenhaus der Stadt Wien (AKH Wien) | Vienna | 1090 | Austria |
| Universitair Ziekenhuis Leuven | Leuven | 3000 | Belgium |
| Centro Hospitalar e Universitario de Coimbra | Coimbra | 3004-561 | Brazil |
| Hospital Geral de Fortaleza | Fortaleza | 60156-290 | Brazil |
| Santa Casa de Misericordia de Porto Alegre - Hospital Dom Vicente Scherer | Porto Alegre | 90020-090 | Brazil |
| Hospital de Base | São Jose Do Rio Preto | 15090-000 | Brazil |
| Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo (HC-FMUSP) | São Paulo | 05403-000 | Brazil |
| Hôpital Maisonneuve-Rosemont - Centre de recherche | Montreal | H1T 2M4 | Canada |
| McGill University Health Centre - Royal Victoria Hospital | Montreal | H4A 3J1 | Canada |
| Vancouver Coastal Health - Vancouver General Hospital Diamond Healthcare Centre | Vancouver | V5Z 1M9 | Canada |
| Providence Health Care - St. Pauls Hospital | Vancouver | V6Z 1Y6 | Canada |
| CHU Bordeaux - Groupe Hospitalier Pellegrin | Bordeaux | 33076 | France |
| Assistance Publique Hopitaux de Paris (AP-HP) - Hopital Henri Mondor | Créteil | 94000 | France |
| CHU Grenoble Alpes - Hopital Michallon | La Tronche | 38700 | France |
| Assistance Publique Hopitaux de Paris (AP-HP) - Hopital Necker-Enfants Malades | Paris | 75015 | France |
| CHU de Toulouse - Hopital Rangueil | Toulouse | 31400 | France |
| CHRU de Tours - Hopital Bretonneau | Tours | 37000 | France |
| Azienda Ospedaliero Universitaria di Bologna Policlinico di Sant'Orsola | Bologna | 40138 | Italy |
| Azienda Ospedale Universita Padova | Padova | 35128 | Italy |
| Azienda Ospedaliero Universitaria Citta della Salute e della Scienza di Torino - Presidio Molinette | Torino | 10126 | Italy |
| Centro Hospitalar de Lisboa Ocidental EPE - Hospital de Santa Cruz | Carnaxide | 2790-134 | Portugal |
| Centro Hospitalar Universitario Lisboa Central EPE - Hospital Curry Cabral | Lisbon | 1069-099 | Portugal |
| Centro Hospitalar Universitario de Santo Antonio | Porto | 4099-001 | Portugal |
| Hospital Universitari Germans Trias i Pujol (HUGTP) | Badalona | 08916 | Spain |
| Hospital del Mar | Barcelona | 08003 | Spain |
| Fundacio Puigvert | Barcelona | 08025 | Spain |
| Hospital Universitario Vall d'Hebron | Barcelona | 08035 | Spain |
| Hospital Universitario Virgen de las Nieves - Hospital General | Granada | 18014 | Spain |
| Hospital Universitari de Bellvitge | L'Hospitalet de Llobregat | 08907 | Spain |
| Hospital Universitari Doctor Peset | Valencia | 46017 | Spain |
| Hospital Universitario Miguel Servet | Zaragoza | 50009 | Spain |
| Sahlgrenska Universitetssjukhuset | Gothenburg | 41345 | Sweden |
| Akademiska sjukhuset | Uppsala | 75185 | Sweden |
| ID | Term |
|---|---|
| D051799 | Delayed Graft Function |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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