Using warm perfusion to improve kidney transplantation outcomes
Multicenter, Prospective and Open-label Clinical Trial to Evaluate the Viability, Performance and Safety of ex Vivo Normothermic Perfusion in Kidney Transplantation From DCD and DBD Donors.
This study is testing a new device that keeps kidneys warm and healthy before transplanting them to see if it helps improve the success of kidney transplants from deceased donors.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ebers Medical Technology, S.L. Industry-sponsored |
| Locations | 1 site (Zaragoza) |
| Trial ID | NCT05175885 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include patients aged 18 and older on dialysis awaiting their first or second kidney transplant from specific donor types.
Not a fit: Patients with two or more previous kidney transplantations or those receiving dual kidney transplants may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve kidney transplant outcomes and increase the availability of viable organs.
How similar studies have performed: While the concept of ex vivo normothermic perfusion is gaining interest, this specific application in kidney transplantation is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Zaragoza
- Miguel Servet University Hospital — 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.