Actively Recruiting
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.
Led by Ebers Medical Technology, S.L. · Updated on 2024-11-12
100
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, performance, and viability of ex vivo normothermic perfusion (EVNP) in kidney transplantation using the Ark Kidney device. This study focuses on kidneys donated from controlled donation after circulatory death (DCD) and donation after brain death (DBD) donors, aiming to improve preservation and resuscitation before transplantation. The Ark Kidney system is a portable device that continuously perfuses the donated kidney with warm oxygenated blood supplemented with erythrocytes. It includes a permanent unit and a disposable circuit replaced after each use to maintain sterility. The study compares the EVNP method with a historical control group of patients who received kidneys preserved by traditional cold methods. During perfusion, the system monitors parameters such as perfusion conditions and urine output. Participants will undergo kidney transplantation with monitoring for safety and function over the course of one year. Researchers will assess adverse events, delayed graft function, graft survival, and patient survival, among other measures. Follow-up includes evaluation of kidney function at several time points up to 90 days and longer-term outcomes at one year.
CONDITIONS
Brief 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 at their site
- Candidates receiving a first or second kidney transplant from a controlled DCD donor or a DBD donor aged 70 years or older
- Patients who have provided written informed consent or have legal guardian approval if mentally incapacitated
- Patients able to comply with study requirements for the 1-year duration
- Patients meeting local clinical acceptance criteria for kidney transplant recipients
You will not qualify if you...
- More than one previous kidney transplantation
- Dual kidney or multivisceral transplantation
- Organs with expected cold ischemia time before EVNP over 20 hours
- Organs from hepatitis B surface antigen-positive or hepatitis C viremic donors
- Organs with multiple arteries
- Recipients with body mass index 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 score over 50%
- Known allergies to perfusate components
- Preexisting vascular disease causing technical difficulty for transplantation
- Presence of clinically relevant donor-specific anti-HLA antibodies
- ABO incompatibility
- History of alcohol or drug abuse in last two years
- Use of normothermic regional perfusion during organ harvesting
- Participation in another clinical study or trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Organ preservation and transplantation occur on the day of surgery
Participants receive kidney transplantation where the donated kidney is preserved using ex vivo normothermic perfusion with the Ark Kidney System or cold preservation methods prior to transplantation.
1 transplant procedure visit (in-person)
Duration - Up to 1 year
Participants are monitored for safety, graft function, and survival following kidney transplantation.
Multiple follow-up visits over 1 year including assessments at 1 day, 3 days, 5 days, 7 days, 30 days, 90 days, and 1 year
Trial Site Locations
Total: 1 location
1
Miguel Servet University Hospital
Zaragoza, Spain
Actively Recruiting
Research Team
P
Pedro Moreo Calvo, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here