Predictive Accuracy of Machine Perfusion for Kidney Transplant Outcomes in Germany

NCT07348874 | Not Yet Recruiting

• Study Type: observational
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief 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

Organ Preservation; Kidney Transplant; Renal Transplant

Keywords

Machine Perfusion; Hypothermic Machine Perfusion; Upfront Machine Perfusion; Continuous Machine Perfusion; Organ Preservation; Marginal Allograft

Outcome Measures

Primary Outcomes (1)

• Kidney Function

  Kidney function assessed by the estimated glomerular filtration rate

  1 year after kidney transplantation

Secondary Outcomes (6)

• Recipient and graft survival

  1 year after kidney transplantation

• Kidney function

  1, 3 and 6 months after kidney transplantation

• Delayed Graft Function (DGF)

  7 days after kidney transplantation

• Primary Non-Function

  3 months after kidney transplantation

• Total organ preservation of the donor kidney

  From placement of the donor kidney to the machine perfusion device until removal of the donor kidney from the machine perfusion device (measured in minutes)

Study Arms (1)

Continuous HMP

Patients receiving ECD-DBD kidney allograft after continuous HMP at German Transplant centres

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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

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

Sponsors & Collaborators

• University Hospital Heidelberg: lead

Central Study Contacts

Peri Husen, MD

CONTACT

0049622156310228; peri.husen@med.uni-heidelberg.de

Deniz Uluk, MD

CONTACT

004962215638948; deniz.uluk@med.uni-heidelberg.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 30, 2025
• First Posted: January 16, 2026
• Study Start: January 19, 2026
• Primary Completion (Estimated): January 19, 2028
• Study Completion (Estimated): February 1, 2028
• Last Updated: January 16, 2026

Record last verified: 2026-01