Predictive Accuracy of Machine Perfusion for Kidney Transplant Outcomes in Germany

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Conditions studied: Kidney Transplant, Renal Transplant, Organ Preservation

In brief

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.

Key facts

Study ID

NCT07348874

Run by

University Hospital Heidelberg

People needed

300

Starts

2026-01-19

Expected to finish

2028-02-01

Last updated by the study team

2026-01-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• Kidney allograft being transported at continuous HMP
• Transplantation of recipient at a national transplant center
• Extended Criteria Donation:
• Donor age ≥ 60 years 2. Donor age 50 - 59 plus 2 additional attributes: I. Arterial hypertension in medical history II. Last serum creatinine >1.5mg/dL (133mmol/L) III. Cerebrovascular cause of death

You may not qualify if…

• 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
• Mentally or legally incapacitated
• Inability to understand the procedures due to language barriers

Full record on ClinicalTrials.gov

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