Z94.0
Conditions
Interventions
Group 1: Observational cohorts (primary/comparator cohorts)
Cohort 1 – HMP/omics cohort (primary):
Recipients of a deceased-donor extended-criteria donor (ECD) kidney preserved by hypothermic machine
pre-implantation baseline biopsy: transcriptomics).
Group 2: Cohort 2 – Non-HMP cohort (optional, prospective):
Recipients of a deceased-donor ECD kidney without HMP preservation, e.g. not machine-per
clinical outcome data are collected for contextualization.
Group 3: Cohort 3 – Historical non-HMP cohort (optional, retrospective):
Recipients of a deceased-donor ECD kidney without HMP from the prede
Sponsors
Innere Medizin X:Klinik für Nephrologie
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: -Kidney transplantation of a deceased-donor extended-criteria donor (ECD) kidney at the study center. ECD is defined in accordance with the German Medical Association guideline as donor age >60 years, or donor age 50–59 years plus at least two of the following: cerebrovascular cause of death, arterial hypertension, serum creatinine =1.5 mg/dL (=132 µmol/L) -Membership in one of the following groups: HMP cohort: ECD kidney preserved using hypothermic machine perfusion (multi-omics analyses planned). Comparator cohort (optional): ECD kidney without HMP (not machine-perfused for logistical/technical reasons or imported organ without HMP) and/or a historical ECD cohort (clinical data analysis only)
Exclusion criteria
Exclusion criteria: -Non-evaluable/missing data (e.g., missing clinical outcome data and/or missing sample/omics data required for the respective analyses)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| -Delayed graft function (DGF): defined as the need for dialysis within the first 7 days after transplantation -Primary biomarker-based analysis: association of multi-omics markers/marker panels (perfusate metabolomics/proteomics and baseline biopsy transcriptomics) with the occurrence of DGF | — |
Secondary
| Measure | Time frame |
|---|---|
| -Kidney function: serum creatinine, eGFR, and proenkephalin at hospital discharge and at 1, 3, 6, and 12 months post-transplantation -Primary graft non-function (PNF) -12-month graft outcome: death-censored graft survival and kidney function (serum creatinine, eGFR, and proteinuria) -Development of chronic graft dysfunction/chronic kidney disease (CKD) after transplantation -Biomarker-based analyses (for all secondary endpoints): For all secondary endpoints, the association and/or predictive performance of multi-omics–based markers/marker panels (perfusate metabolomics/proteomics and baseline biopsy transcriptomics) will be evaluated | — |
Countries
Germany
Contacts
Public ContactLouise Benning
Innere Medizin X:Klinik für Nephrologie
Outcome results
None listed