ClinicalTrials.Veeva

Menu

ARGX-117 in Deceased Donor Kidney Transplant Recipients At Risk for Delayed Graft Function (VARVARA)

argenx logo

argenx

Status and phase

Enrolling
Phase 2

Conditions

Delayed Graft Function

Treatments

Biological: ARGX-117
Other: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT05907096
ARGX-117-2201
2022-503091-89-00 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

102 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

102 participants in 2 patient groups, including a placebo group

ARGX-117
Experimental group
Description:
Patients receiving ARGX-117 intravenous infusions
Treatment:
Biological: ARGX-117
Placebo
Placebo Comparator group
Description:
Patients receiving placebo intravenous infusions
Treatment:
Other: Placebo

Trial contacts and locations

34

Loading...

Central trial contact

Sabine Coppieters, MD

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems