Predictive Accuracy of Machine Perfusion for Kidney Transplant Outcomes in Germany
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital Heidelberg
About this trial
Kidney transplantation remains the only definitive treatment for end-stage renal disease, yet the increasing use of extended criteria donor (ECD) kidneys heightens the risk of ischemia-reperfusion injury, particularly under static cold storage (SCS). Continuous hypothermic machine perfusion (HMP) has been introduced to improve preservation quality, but robust clinical evidence regarding its predictive value for post-transplant outcomes in ECD kidneys after donation after brain death (DBD) is limited.
The PRE-MAP Kidney Study is a prospective, non-interventional, multicenter observational study conducted across all German transplant centers. The study systematically collects technical machine perfusion parameters (flow, resistance, perfusion duration) and correlates these with clinical outcomes following kidney transplantation.
The primary endpoint is 12-month kidney function (eGFR). Secondary endpoints include surgical complications, length of stay, and transplant-specific events (acute rejection, primary non-function, delayed graft function).
This national cohort aims to determine the prognostic significance of HMP parameters in marginal donor kidneys and to generate evidence supporting future recommendations for organ preservation and allocation practices.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Signed informed consent
Patients 18 years or older
Listed for kidney transplantation (KT)
Receiving ECD* donation after brain death kidney allografts following national organ procurement
Disqualifiers
Recipients of living donor KT
Combined transplantations (liver-kidney, kidney-pancreas, etc.)
Participation in another intervention-trial with interference of intervention and/or outcome of this study
Unwilling or unable to follow the procedures outlined in the protocol
Trial population
All patients waitlisted at a German transplant center for kidney transplantation receiving an ECD donor allograft from donation after brain death after continuous hypothermic oxygenated machine perfusion
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
300 Participants
are grouped into 1 trial groupGroup A: Continuous HMP
Trial outcomes
Primary outcomes
1
Kidney Function
Kidney function assessed by the estimated glomerular filtration rate
Time frame
1 year after kidney transplantationSecondary outcomes
1
Recipient and graft survival
Recipient graft survival
Time frame
1 year after kidney transplantation2
Kidney function
Kidney function assessed by estimated glomerular filtration rate (eGFR)
Time frame
1, 3 and 6 months after kidney transplantation3
Delayed Graft Function (DGF)
Incidence of delayed graft function (requirement of dialysis during the first week following kidney transplantation with return of kidney function)
Time frame
7 days after kidney transplantation4
Primary Non-Function
Primary non-function (PNF): patient requires dialysis at 3 months after kidney transplantation
Time frame
3 months after kidney transplantationLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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