Using warm perfusion to improve kidney transplantation outcomes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical investigation evaluates the viability, performance, and safety of a device called Ark Kidney, which utilizes ex vivo normothermic perfusion to preserve kidneys from deceased donors before transplantation. The device continuously circulates a warm, oxygenated perfusate through the kidney, allowing for better organ resuscitation and monitoring during the perfusion process. The study focuses on kidneys from both controlled donation after circulatory death (DCD) and donation after brain death (DBD) donors, aiming to enhance transplant success rates.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Patients aged 18 years and older
2. Patients undergoing renal replacement therapy by means of dialysis and included in the waiting list for renal transplantation in their respective site.
3. Candidates to receive a first or second renal transplant from (i) a Maastricht type III (Maastricht classification) controlled DCD donor or (ii) a DBD donor aged 70 years or older.
4. Patients that have given informed consent in written form before their inclusion in the study. In case of compromised mental capacity, the approval and signature of a legal guardian will be required.
5. Patients compliant with the requirements of the study and without impediments to follow the instructions throughout the 1-year duration of the study.
6. Patients that meet the acceptance criteria for kidney transplant recipients established in the clinical site in agreement with usual clinical practice.

Exclusion Criteria:

1. Two or more previous kidney transplantations
2. Dual kidney transplantation or multivisceral transplantation (e.g. a pancreas-kidney transplantation)
3. Recipients of an organ with any of the following characteristics:

   1. Expected cold ischemia time before EVNP \> 20 hours
   2. Organ from hepatitis B surface antigen-positive or hepatitis C viremic donor
   3. Organ with multiple arteries
4. Recipients with body mass index (BMI) \> 40 kg/m2
5. Diagnosis of focal segmental glomerulosclerosis (FSGS) or membranoproliferative glomerulonephritis with high recurrence risk after transplantation in the eyes of the investigator.
6. Diagnosis of atypical hemolytic-uremic syndrome or thrombotic microangiopathy at the moment of inclusion
7. Diagnosis of antiphospholipid syndrome at the moment of inclusion
8. Panel-reactive antibodies (PRA) score \> 50%
9. Known allergies to any of the components of the perfusate
10. Preexisting vascular disease that represents an extraordinary technical difficulty for the transplantation in the opinion of the investigator
11. Presence of clinically relevant donor-specific anti-HLA antibodies
12. ABO incompatibility
13. History of alcohol or drug abuse in the last two years
14. Use of normothermic regional perfusion during the organ harvesting process
15. Participation of the patient in another study or clinical trial.

Where it's running

• Miguel Servet University Hospital
  Zaragoza, Zaragoza, Spain Recruiting

Study contacts

• Principal investigator: Alex Gutierrez-Dalmau, MD — Miguel Servet University Hospital
• Study coordinator: Pedro Moreo Calvo, PhD
• Email: info@ebersmedical.com
• Phone: +34 876 013 826

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Vonoprazan to reduce delayed graft function after deceased-donor kidney transplant

  This trial will test whether giving vonoprazan around the time of surgery lowers the chance of delayed graft function in adults receiving their first deceased-donor kidney transplant.

  Recruiting Phase 1/2 First Affiliated Hospital of Chongqing Medical University · Chongqing and 1 other locations · NCT07275632

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.