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ARGX-117 in Deceased Donor Kidney Transplant Recipients at Risk for Delayed Graft Function (Varvara)
EU CTIS ID: 2022-503091-89-00
What this study is testing
To evaluate the efficacy of ARGX-117 compared to placebo in improving allograft function in deceased donor kidney transplants at risk for DGF.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Is at least the local legal age of consent for clinical studies and at least aged 18 years and less than 70 years when signing the ICF
- 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.
You likely can't join if
- Any history of prothrombotic disorder, or history of thrombosis or hypercoagulable state, excluding vascular access clotting
- Pregnant or lactating state or intention to become pregnant during the study
- 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.
See the full eligibility criteria
- Is at least the local legal age of consent for clinical studies and at least aged 18 years and less than 70 years when signing the ICF
- 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.
- Any history of prothrombotic disorder, or history of thrombosis or hypercoagulable state, excluding vascular access clotting
- Pregnant or lactating state or intention to become pregnant during the study
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Canada
- Australia
- Brazil
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Canada; Australia; Brazil; United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.