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New treatment option for Kidney Transplantation
Official title Ex Vivo Normothermic Perfusion in Kidney Transplantation.
ClinicalTrials.gov ID: NCT05175885
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients aged 18 years and older
- Patients undergoing renal replacement therapy by means of dialysis and included in the waiting list for renal transplantation in their respective...
- Candidates to receive a first or second renal transplant from (i) a Maastricht type III (Maastricht classification) controlled DCD donor or (ii) a...
- Patients that have given informed consent in written form before their inclusion in the study. In case of compromised mental capacity, the approval...
- Patients compliant with the requirements of the study and without impediments to follow the instructions throughout the 1-year duration of the study.
You likely can't join if
- Two or more previous kidney transplantations
- Dual kidney transplantation or multivisceral transplantation (e.g. a pancreas-kidney transplantation)
- Recipients of an organ with any of the following characteristics:
- Expected cold ischemia time before EVNP \> 20 hours
- Organ from hepatitis B surface antigen-positive or hepatitis C viremic donor
- Organ with multiple arteries
See the full eligibility criteria
- Patients aged 18 years and older
- Patients undergoing renal replacement therapy by means of dialysis and included in the waiting list for renal transplantation in their respective site.
- 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.
- 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.
- Patients compliant with the requirements of the study and without impediments to follow the instructions throughout the 1-year duration of the study.
- Patients that meet the acceptance criteria for kidney transplant recipients established in the clinical site in agreement with usual clinical practice.
- Two or more previous kidney transplantations
- Dual kidney transplantation or multivisceral transplantation (e.g. a pancreas-kidney transplantation)
- Recipients of an organ with any of the following characteristics:
- Expected cold ischemia time before EVNP \> 20 hours
- Organ from hepatitis B surface antigen-positive or hepatitis C viremic donor
- Organ with multiple arteries
- Recipients with body mass index (BMI) \> 40 kg/m2
- Diagnosis of focal segmental glomerulosclerosis (FSGS) or membranoproliferative glomerulonephritis with high recurrence risk after transplantation in the eyes of the investigator.
- Diagnosis of atypical hemolytic-uremic syndrome or thrombotic microangiopathy at the moment of inclusion
- Diagnosis of antiphospholipid syndrome at the moment of inclusion
- Panel-reactive antibodies (PRA) score \> 50%
- Known allergies to any of the components of the perfusate
- Preexisting vascular disease that represents an extraordinary technical difficulty for the transplantation in the opinion of the investigator
- Presence of clinically relevant donor-specific anti-HLA antibodies
- ABO incompatibility
- History of alcohol or drug abuse in the last two years
- Use of normothermic regional perfusion during the organ harvesting process
- Participation of the patient in another study or clinical trial.
The study team makes the final eligibility decision.
Where it's taking place
- Zaragoza, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Zaragoza, Spain. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.