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Predictive Accuracy of Machine Perfusion for Kidney Transplant Outcomes in Germany

NCT07348874 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2026-01-16

No results posted yet for this study

Summary

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.

Conditions

  • Kidney Transplant
  • Renal Transplant
  • Organ Preservation

Sponsors & Collaborators

  • University Hospital Heidelberg

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-19
Primary Completion
2028-01-19
Completion
2028-02-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07348874 on ClinicalTrials.gov