Ex Vivo Normothermic Perfusion in Kidney Transplantation.

Launched by EBERS MEDICAL TECHNOLOGY, S.L. · Dec 15, 2021

Keywords

ClinConnect Summary

This clinical trial, titled "Ex Vivo Normothermic Perfusion in Kidney Transplantation," is exploring a new technique to improve kidney transplants. The researchers want to see if a method called ex vivo normothermic perfusion (which means keeping the kidney at normal body temperature while it's outside the body) can help ensure that kidneys from both living and deceased donors are healthy and safe for transplant. The trial is currently looking for participants who are 18 years or older and are on dialysis while waiting for a kidney transplant. Specifically, they are targeting those who may receive a kidney from certain types of deceased donors.

If you or a loved one is considering participating, you should know that participants will need to provide written consent and meet specific health criteria. Some of the key eligibility requirements include being a first or second-time kidney transplant candidate and not having certain serious health conditions. Throughout the one-year study, participants will be monitored to ensure their safety and the success of the transplant. This trial aims to provide valuable insights into improving kidney transplantation outcomes, potentially benefiting many patients in need of a transplant.

Gender

ALL

Eligibility 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.