Predictive Accuracy of Machine Perfusion for Kidney Transplant Outcomes in Germany

Sponsor
University Hospital Heidelberg
Study ID
NCT07348874
Status
Not Yet Recruiting

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Conditions

  • Kidney Transplant
  • Organ Preservation
  • Renal Transplant

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Study Details

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 Dates

First listed
Jan 16, 2026
Start date
Jan 19, 2026
Status verified
Jan 2026
Primary completion
Jan 19, 2028
Completion
Feb 1, 2028

Study Design

Enrollment
300 participants (estimated)

Arms

  • Arm: Continuous HMP
    Patients receiving ECD-DBD kidney allograft after continuous HMP at German Transplant centres

Primary Outcome Measure

Kidney Function [ Time Frame: 1 year after kidney transplantation ]

Central Contacts

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