Actively Recruiting
Ex Vivo Normothermic Perfusion in Kidney Transplantation.
Led by Ebers Medical Technology, S.L. · Updated on 2024-11-12
100
Participants Needed
1
Research Sites
206 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A multicenter, prospective and open-label clinical investigation to evaluate the viability, performance and safety of ex vivo normothermic perfusion in kidney transplantation from DCD and DBD donors.
CONDITIONS
Official Title
Ex Vivo Normothermic Perfusion in Kidney Transplantation.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 years and older
- Patients undergoing dialysis and listed for kidney transplantation
- Candidates for first or second kidney transplant from controlled DCD donors or DBD donors aged 70 years or older
- Patients who provide written informed consent or have legal guardian approval if mentally compromised
- Patients able to comply with study requirements for 1 year
- Patients meeting clinical site criteria for kidney transplant recipients according to usual practice
You will not qualify if you...
- Two or more previous kidney transplantations
- Dual kidney or multivisceral transplantation (e.g., pancreas-kidney)
- Expected cold ischemia time before EVNP greater than 20 hours
- Organs from hepatitis B surface antigen-positive or hepatitis C viremic donors
- Organs with multiple arteries
- Recipients with BMI over 40 kg/m2
- Diagnosis of focal segmental glomerulosclerosis or membranoproliferative glomerulonephritis with high recurrence risk
- Diagnosis of atypical hemolytic-uremic syndrome or thrombotic microangiopathy at inclusion
- Diagnosis of antiphospholipid syndrome at inclusion
- Panel-reactive antibodies (PRA) score over 50%
- Known allergies to perfusate components
- Preexisting vascular disease posing exceptional transplant difficulty
- Presence of clinically relevant donor-specific anti-HLA antibodies
- ABO blood group incompatibility
- History of alcohol or drug abuse in last two years
- Use of normothermic regional perfusion during organ harvesting
- Participation in another clinical trial
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Miguel Servet University Hospital
Zaragoza, Spain
Actively Recruiting
Research Team
P
Pedro Moreo Calvo, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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