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

Last updated: March 26, 2025
Sponsor: argenx
Overall Status: Active - Recruiting

Phase

2

Condition

N/A

Treatment

Placebo

ARGX-117

Clinical Study ID

NCT05907096
ARGX-117-2201
2022-503091-89-00
  • Ages 18-70
  • All Genders

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 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

Total Participants: 102
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
February 17, 2024
Estimated Completion Date:
December 31, 2026

Connect with a study center

  • Royal Adelaide Hospital

    Adelaide, SA 5000
    Australia

    Active - Recruiting

  • Monash Health - Monash Medical Centre

    Clayton, 3168
    Australia

    Active - Recruiting

  • Princess Alexandra Hospital

    Woolloongabba, QLD 4102
    Australia

    Active - Recruiting

  • Tirol Kliniken - A.o. Landeskrankenhaus Innsbruck

    Innsbruck, 6020
    Austria

    Active - Recruiting

  • Allgemeines Krankenhaus der Stadt Wien (AKH Wien)

    Wien, 1090
    Austria

    Active - Recruiting

  • Universitair Ziekenhuis Leuven

    Leuven, 3000
    Belgium

    Active - Recruiting

  • Centro Hospitalar e Universitario de Coimbra

    Coimbra, 3004-561
    Brazil

    Active - Recruiting

  • Hospital Geral de Fortaleza

    Fortaleza, 60156-290
    Brazil

    Active - Recruiting

  • Santa Casa de Misericordia de Porto Alegre - Hospital Dom Vicente Scherer

    Porto Alegre, 90020-090
    Brazil

    Active - Recruiting

  • Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo (HC-FMUSP)

    Sao Paulo, 05403-000
    Brazil

    Active - Recruiting

  • Hospital de Base

    São Jose do Rio Preto, 15090-000
    Brazil

    Active - Recruiting

  • Hôpital Maisonneuve-Rosemont - Centre de recherche

    Montréal, H1T 2M4
    Canada

    Active - Recruiting

  • McGill University Health Centre - Royal Victoria Hospital

    Montréal, H4A 3J1
    Canada

    Active - Recruiting

  • Providence Health Care - St. Pauls Hospital

    Vancouver, V6Z 1Y6
    Canada

    Active - Recruiting

  • Vancouver Coastal Health - Vancouver General Hospital Diamond Healthcare Centre

    Vancouver, V5Z 1M9
    Canada

    Active - Recruiting

  • CHU Bordeaux - Groupe Hospitalier Pellegrin

    Bordeaux, 33076
    France

    Active - Recruiting

  • Assistance Publique Hopitaux de Paris (AP-HP) - Hopital Henri Mondor

    Creteil, 94000
    France

    Active - Recruiting

  • CHU Grenoble Alpes - Hopital Michallon

    La Tronche, 38700
    France

    Active - Recruiting

  • Assistance Publique Hopitaux de Paris (AP-HP) - Hopital Necker-Enfants Malades

    Paris, 75015
    France

    Active - Recruiting

  • CHU de Toulouse - Hopital Rangueil

    Toulouse, 31400
    France

    Active - Recruiting

  • CHRU de Tours - Hopital Bretonneau

    Tours, 37000
    France

    Active - Recruiting

  • Azienda Ospedaliero Universitaria di Bologna Policlinico di Sant'Orsola

    Bologna, 40138
    Italy

    Active - Recruiting

  • Azienda Ospedale Universita Padova

    Padova, 35128
    Italy

    Active - Recruiting

  • Azienda Ospedaliero Universitaria Citta della Salute e della Scienza di Torino - Presidio Molinette

    Torino, 10126
    Italy

    Active - Recruiting

  • Centro Hospitalar de Lisboa Ocidental EPE - Hospital de Santa Cruz

    Carnaxide, 2790-134
    Portugal

    Active - Recruiting

  • Centro Hospitalar Universitario Lisboa Central EPE - Hospital Curry Cabral

    Lisboa, 1069-099
    Portugal

    Active - Recruiting

  • Centro Hospitalar Universitario de Santo Antonio

    Porto, 4099-001
    Portugal

    Active - Recruiting

  • Hospital Universitari Germans Trias i Pujol (HUGTP)

    Badalona, 08916
    Spain

    Active - Recruiting

  • Fundacio Puigvert

    Barcelona, 08025
    Spain

    Active - Recruiting

  • Hospital Universitario Vall d'Hebron

    Barcelona, 08035
    Spain

    Active - Recruiting

  • Hospital del Mar

    Barcelona, 08003
    Spain

    Active - Recruiting

  • Hospital Universitario Virgen de las Nieves - Hospital General

    Granada, 18014
    Spain

    Active - Recruiting

  • Hospital Universitari de Bellvitge

    L'Hospitalet De Llobregat, 08907
    Spain

    Active - Recruiting

  • Hospital Universitari Doctor Peset

    Valencia, 46017
    Spain

    Active - Recruiting

  • Hospital Universitario Miguel Servet

    Zaragoza, 50009
    Spain

    Active - Recruiting

  • Sahlgrenska Universitetssjukhuset

    Gothenburg, 41345
    Sweden

    Active - Recruiting

  • Akademiska sjukhuset

    Uppsala, 75185
    Sweden

    Active - Recruiting

  • Cedars-Sinai Medical Center

    Los Angeles, California 90048
    United States

    Active - Recruiting

  • Tampa General Hospital

    Tampa, Florida 33606
    United States

    Active - Recruiting

  • University of Illinois (UI) Health - Outpatient Care Center

    Chicago, Illinois 60612
    United States

    Active - Recruiting

  • Cooperman Barnabas Medical Center

    Livingston, New Jersey 07039
    United States

    Active - Recruiting

  • Erie County Medical Center

    Buffalo, New York 14215
    United States

    Active - Recruiting

  • Columbia University

    New York, New York 10032
    United States

    Active - Recruiting

  • The Ohio State University

    Columbus, Ohio 43210
    United States

    Active - Recruiting

  • University of Texas Southwestern Medical Center

    Dallas, Texas 10267
    United States

    Active - Recruiting

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