Clinical trial NCT05907096: ARGX-117 in Deceased Donor Kidney Transplant Recipients at Risk for Delayed Graft Function
Official title: A Phase 2, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Study to Assess the Safety, Efficacy, and Tolerability of ARGX-117 in Improving Allograft Function in Recipients of a Deceased Donor Renal Allograft at Risk for Delayed Graft Function
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Delayed Graft Function
Lead sponsor: argenx
Sponsor class: INDUSTRY
First posted: 2023-06-18
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: eGFR at 24 weeks posttransplant
timeFrame: Up to 24 weeks
Secondary outcomes:
measure: Proportion of participants with Delayed Graft Function (DGF)
timeFrame: Up to 52 weeks
measure: Proportion of participants with fDGF (functional delayed graft function)
timeFrame: Up to 52 weeks
measure: Duration of dialysis treatment for DGF within the first 30 days posttransplant
timeFrame: up to 30 days
measure: Proportion of participants who have ongoing dialysis requirement at study day 31
timeFrame: Up to 31 days
measure: CRR at 72 hours posttransplant and on study day 8
timeFrame: up to 8 days
measure: iBox score at 52 weeks posttransplant
timeFrame: up to 52 weeks
measure: Dialysis-free participant survival through 52 weeks posttransplant
timeFrame: up to 52 weeks
measure: (Death-censored) allograft survival through 52 weeks posttransplant
timeFrame: Up to 52 weeks
measure: eGFR at 52 weeks posttransplant
timeFrame: up to 52 weeks
measure: Incidence of Primary Nonfunction (PNF)
timeFrame: up to 12 weeks
measure: Serum concentrations for ARGX 117
timeFrame: up to 64 weeks
measure: Values from baseline in free C2, total C2, and CH50
timeFrame: up to 64 weeks
measure: Incidence of anti-drug antibodies (ADA) against ARGX-117
timeFrame: up to 64 weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
city: Chicago
country: United States
facility: University of Illinois (UI) Health - Outpatient Care Center
state: Illinois
city: Livingston
country: United States
facility: Cooperman Barnabas Medical Center
state: New Jersey
city: Buffalo
country: United States
facility: Erie County Medical Center
state: New York
city: New York
country: United States
facility: Columbia University
state: New York
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
city: Clayton
country: Australia
facility: Monash Health - Monash Medical Centre
city: Woolloongabba
country: Australia
facility: Princess Alexandra Hospital
city: Innsbruck
country: Austria
facility: Tirol Kliniken - A.o. Landeskrankenhaus Innsbruck
city: Wien
country: Austria
facility: Allgemeines Krankenhaus der Stadt Wien (AKH Wien)
city: Leuven
country: Belgium
facility: Universitair Ziekenhuis Leuven
city: Coimbra
country: Brazil
facility: Centro Hospitalar e Universitario de Coimbra
city: Fortaleza
country: Brazil
facility: Hospital Geral de Fortaleza
city: Porto Alegre
country: Brazil
facility: Santa Casa de Misericordia de Porto Alegre - Hospital Dom Vicente Scherer
city: Sao Paulo
country: Brazil
facility: Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo (HC-FMUSP)
city: São Jose do Rio Preto
country: Brazil
facility: Hospital de Base
city: Montréal
country: Canada
facility: Hôpital Maisonneuve-Rosemont - Centre de recherche
city: Montréal
country: Canada
facility: McGill University Health Centre - Royal Victoria Hospital
city: Vancouver
country: Canada
facility: Vancouver Coastal Health - Vancouver General Hospital Diamond Healthcare Centre
city: Vancouver
country: Canada
facility: Providence Health Care - St. Pauls Hospital
city: Bordeaux
country: France
facility: CHU Bordeaux - Groupe Hospitalier Pellegrin
city: Creteil
country: France
facility: Assistance Publique Hopitaux de Paris (AP-HP) - Hopital Henri Mondor
city: La Tronche
country: France
facility: CHU Grenoble Alpes - Hopital Michallon
city: Paris
country: France
facility: Assistance Publique Hopitaux de Paris (AP-HP) - Hopital Necker-Enfants Malades
city: Toulouse
country: France
facility: CHU de Toulouse - Hopital Rangueil
city: Tours
country: France
facility: CHRU de Tours - Hopital Bretonneau
city: Bologna
country: Italy
facility: Azienda Ospedaliero Universitaria di Bologna Policlinico di Sant'Orsola
city: Padova
country: Italy
facility: Azienda Ospedale Universita Padova
city: Torino
country: Italy
facility: Azienda Ospedaliero Universitaria Citta della Salute e della Scienza di Torino - Presidio Molinette
city: Carnaxide
country: Portugal
facility: Centro Hospitalar de Lisboa Ocidental EPE - Hospital de Santa Cruz
city: Lisboa
country: Portugal
facility: Centro Hospitalar Universitario Lisboa Central EPE - Hospital Curry Cabral
city: Porto
country: Portugal
facility: Centro Hospitalar Universitario de Santo Antonio
city: Badalona
country: Spain
facility: Hospital Universitari Germans Trias i Pujol (HUGTP)
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Fundacio Puigvert
city: Barcelona
country: Spain
facility: Hospital Universitario Vall d'Hebron
city: Granada
country: Spain
facility: Hospital Universitario Virgen de las Nieves - Hospital General
city: L'Hospitalet De Llobregat
country: Spain
facility: Hospital Universitari de Bellvitge
city: Valencia
country: Spain
facility: Hospital Universitari Doctor Peset
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet
city: Gothenburg
country: Sweden
facility: Sahlgrenska Universitetssjukhuset
city: Uppsala
country: Sweden
facility: Akademiska sjukhuset
Study officials:
References: