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

NCT05907096 | Active Not Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: ARGX-117-22012022-503091-89-00
• Study Type: interventional
• Target: 103
• Locations: 10 countries
• Sites: 42

Brief 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.

Conditions

Delayed Graft Function

Outcome Measures

Primary Outcomes (1)

• eGFR at 24 weeks posttransplant

  Estimated glomerular filtration rate

  Up to 24 weeks

Secondary Outcomes (13)

• Proportion of participants with Delayed Graft Function (DGF)

  Up to 52 weeks

• Proportion of participants with fDGF

  Up to 52 weeks

• 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

  up to 8 days

Study Arms (2)

ARGX-117

EXPERIMENTAL

Patients receiving ARGX-117 intravenous infusions

Biological: ARGX-117

Placebo

PLACEBO COMPARATOR

Patients receiving placebo intravenous infusions

Other: Placebo

Interventions

ARGX-117 BIOLOGICAL

Intravenous administration of ARGX-117

ARGX-117

Placebo OTHER

Intravenous administration of placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• argenx: lead

Study Sites (45)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Tampa General Hospital

Tampa, Florida, 33606, United States

Location

University of Illinois (UI) Health - Outpatient Care Center

Chicago, Illinois, 60612, United States

Location

Cooperman Barnabas Medical Center

Livingston, New Jersey, 07039, United States

Location

Erie County Medical Center

Buffalo, New York, 14215, United States

Location

Columbia University

New York, New York, 10032, United States

Location

The Ohio State University

Columbus, Ohio, 43210, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 10267, United States

Location

Royal Adelaide Hospital

Adelaide, SA 5000, Australia

Location

Monash Health - Monash Medical Centre

Clayton, 3168, Australia

Location

Princess Alexandra Hospital

Woolloongabba, QLD 4102, Australia

Location

Tirol Kliniken - A.o. Landeskrankenhaus Innsbruck

Innsbruck, 6020, Austria

Location

Allgemeines Krankenhaus der Stadt Wien (AKH Wien)

Vienna, 1090, Austria

Location

Universitair Ziekenhuis Leuven

Leuven, 3000, Belgium

Location

Centro Hospitalar e Universitario de Coimbra

Coimbra, 3004-561, Brazil

Location

Hospital Geral de Fortaleza

Fortaleza, 60156-290, Brazil

Location

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

Porto Alegre, 90020-090, Brazil

Location

Hospital de Base

São Jose Do Rio Preto, 15090-000, Brazil

Location

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

São Paulo, 05403-000, Brazil

Location

Hôpital Maisonneuve-Rosemont - Centre de recherche

Montreal, H1T 2M4, Canada

Location

McGill University Health Centre - Royal Victoria Hospital

Montreal, H4A 3J1, Canada

Location

Vancouver Coastal Health - Vancouver General Hospital Diamond Healthcare Centre

Vancouver, V5Z 1M9, Canada

Location

Providence Health Care - St. Pauls Hospital

Vancouver, V6Z 1Y6, Canada

Location

CHU Bordeaux - Groupe Hospitalier Pellegrin

Bordeaux, 33076, France

Location

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

Créteil, 94000, France

Location

CHU Grenoble Alpes - Hopital Michallon

La Tronche, 38700, France

Location

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

Paris, 75015, France

Location

CHU de Toulouse - Hopital Rangueil

Toulouse, 31400, France

Location

CHRU de Tours - Hopital Bretonneau

Tours, 37000, France

Location

Azienda Ospedaliero Universitaria di Bologna Policlinico di Sant'Orsola

Bologna, 40138, Italy

Location

Azienda Ospedale Universita Padova

Padua, 35128, Italy

Location

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

Torino, 10126, Italy

Location

Centro Hospitalar de Lisboa Ocidental EPE - Hospital de Santa Cruz

Carnaxide, 2790-134, Portugal

Location

Centro Hospitalar Universitario Lisboa Central EPE - Hospital Curry Cabral

Lisbon, 1069-099, Portugal

Location

Centro Hospitalar Universitario de Santo Antonio

Porto, 4099-001, Portugal

Location

Hospital Universitari Germans Trias i Pujol (HUGTP)

Badalona, 08916, Spain

Location

Hospital del Mar

Barcelona, 08003, Spain

Location

Fundacio Puigvert

Barcelona, 08025, Spain

Location

Hospital Universitario Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital Universitario Virgen de las Nieves - Hospital General

Granada, 18014, Spain

Location

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, 08907, Spain

Location

Hospital Universitari Doctor Peset

Valencia, 46017, Spain

Location

Hospital Universitario Miguel Servet

Zaragoza, 50009, Spain

Location

Sahlgrenska Universitetssjukhuset

Gothenburg, 41345, Sweden

Location

Akademiska sjukhuset

Uppsala, 75185, Sweden

Location

MeSH Terms

Conditions

Delayed Graft Function

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2023
• First Posted: June 18, 2023
• Study Start: February 17, 2024
• Primary Completion: October 16, 2025
• Study Completion (Estimated): July 31, 2026
• Last Updated: March 18, 2026

Record last verified: 2026-03

Locations

BE (1); US (8); ES (8); BR (5); AU (2); SE (2); PT (3); FR (6); CA (4); IT (3)