Phase
Condition
N/ATreatment
Placebo
ARGX-117
Clinical Study ID
Ages 18-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Is at least the local legal age of consent for clinical studies and at least aged 18years 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 3months
Are recipients of de novo or second-time, single kidney transplant from a deceaseddonor, either DCD (donation after cardiac/circulatory death) or DBD ( (donationafter brain death)
Are ABO compatible with donor allograft, except for type A2 donor to type Brecipient kidneys
Have a negative cross match
Have received pretransplant vaccinations for: Neisseria meningitidis, Streptococcuspneumoniae, and Haemophilus influenzae, or are willing to receive the vaccinationsapproximately 3 to 4 months posttransplant
Exclusion
Exclusion Criteria:
Any history of prothrombotic disorder or history of thrombosis or hypercoagulablestate, 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, withthe exception of prior first kidney transplant
High risk within the study period for recurrence of underlying renal disease in theopinion of the investigator
Clinically significant comorbidity, recent major surgery (within 3 months ofscreening), history of any treatment nonadherence, or intention to have surgeryduring the study other than kidney transplantation; or any other medical conditionthat, in the investigator's opinion, would confound the results of the study or putthe participant at undue risk
Clinically significant active bacterial, viral, or fungal infection
History of malignancy unless considered cured by adequate treatment, with noevidence of recurrence for 5 years or more before first study drug administration.Adequately treated participants with the following cancers can be included at anytime: 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 theinvestigator
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
Connect with a study center
Royal Adelaide Hospital
Adelaide, SA 5000
AustraliaActive - Recruiting
Monash Health - Monash Medical Centre
Clayton, 3168
AustraliaActive - Recruiting
Princess Alexandra Hospital
Woolloongabba, QLD 4102
AustraliaActive - Recruiting
Tirol Kliniken - A.o. Landeskrankenhaus Innsbruck
Innsbruck, 6020
AustriaActive - Recruiting
Allgemeines Krankenhaus der Stadt Wien (AKH Wien)
Wien, 1090
AustriaActive - Recruiting
Universitair Ziekenhuis Leuven
Leuven, 3000
BelgiumActive - Recruiting
Centro Hospitalar e Universitario de Coimbra
Coimbra, 3004-561
BrazilActive - Recruiting
Hospital Geral de Fortaleza
Fortaleza, 60156-290
BrazilActive - Recruiting
Santa Casa de Misericordia de Porto Alegre - Hospital Dom Vicente Scherer
Porto Alegre, 90020-090
BrazilActive - Recruiting
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo (HC-FMUSP)
Sao Paulo, 05403-000
BrazilActive - Recruiting
Hospital de Base
São Jose do Rio Preto, 15090-000
BrazilActive - Recruiting
Hôpital Maisonneuve-Rosemont - Centre de recherche
Montréal, H1T 2M4
CanadaActive - Recruiting
McGill University Health Centre - Royal Victoria Hospital
Montréal, H4A 3J1
CanadaActive - Recruiting
Providence Health Care - St. Pauls Hospital
Vancouver, V6Z 1Y6
CanadaActive - Recruiting
Vancouver Coastal Health - Vancouver General Hospital Diamond Healthcare Centre
Vancouver, V5Z 1M9
CanadaActive - Recruiting
CHU Bordeaux - Groupe Hospitalier Pellegrin
Bordeaux, 33076
FranceActive - Recruiting
Assistance Publique Hopitaux de Paris (AP-HP) - Hopital Henri Mondor
Creteil, 94000
FranceActive - Recruiting
CHU Grenoble Alpes - Hopital Michallon
La Tronche, 38700
FranceActive - Recruiting
Assistance Publique Hopitaux de Paris (AP-HP) - Hopital Necker-Enfants Malades
Paris, 75015
FranceActive - Recruiting
CHU de Toulouse - Hopital Rangueil
Toulouse, 31400
FranceActive - Recruiting
CHRU de Tours - Hopital Bretonneau
Tours, 37000
FranceActive - Recruiting
Azienda Ospedaliero Universitaria di Bologna Policlinico di Sant'Orsola
Bologna, 40138
ItalyActive - Recruiting
Azienda Ospedale Universita Padova
Padova, 35128
ItalyActive - Recruiting
Azienda Ospedaliero Universitaria Citta della Salute e della Scienza di Torino - Presidio Molinette
Torino, 10126
ItalyActive - Recruiting
Centro Hospitalar de Lisboa Ocidental EPE - Hospital de Santa Cruz
Carnaxide, 2790-134
PortugalActive - Recruiting
Centro Hospitalar Universitario Lisboa Central EPE - Hospital Curry Cabral
Lisboa, 1069-099
PortugalActive - Recruiting
Centro Hospitalar Universitario de Santo Antonio
Porto, 4099-001
PortugalActive - Recruiting
Hospital Universitari Germans Trias i Pujol (HUGTP)
Badalona, 08916
SpainActive - Recruiting
Fundacio Puigvert
Barcelona, 08025
SpainActive - Recruiting
Hospital Universitario Vall d'Hebron
Barcelona, 08035
SpainActive - Recruiting
Hospital del Mar
Barcelona, 08003
SpainActive - Recruiting
Hospital Universitario Virgen de las Nieves - Hospital General
Granada, 18014
SpainActive - Recruiting
Hospital Universitari de Bellvitge
L'Hospitalet De Llobregat, 08907
SpainActive - Recruiting
Hospital Universitari Doctor Peset
Valencia, 46017
SpainActive - Recruiting
Hospital Universitario Miguel Servet
Zaragoza, 50009
SpainActive - Recruiting
Sahlgrenska Universitetssjukhuset
Gothenburg, 41345
SwedenActive - Recruiting
Akademiska sjukhuset
Uppsala, 75185
SwedenActive - Recruiting
Cedars-Sinai Medical Center
Los Angeles, California 90048
United StatesActive - Recruiting
Tampa General Hospital
Tampa, Florida 33606
United StatesActive - Recruiting
University of Illinois (UI) Health - Outpatient Care Center
Chicago, Illinois 60612
United StatesActive - Recruiting
Cooperman Barnabas Medical Center
Livingston, New Jersey 07039
United StatesActive - Recruiting
Erie County Medical Center
Buffalo, New York 14215
United StatesActive - Recruiting
Columbia University
New York, New York 10032
United StatesActive - Recruiting
The Ohio State University
Columbus, Ohio 43210
United StatesActive - Recruiting
University of Texas Southwestern Medical Center
Dallas, Texas 10267
United StatesActive - Recruiting
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