Molecular Markers of Acute Kidney Injury in Elderly Deceased Donors
MoliDon
1 other identifier
observational
200
1 country
1
Brief Summary
Scoring systems that combine donor clinical and morphological parameters to predict outcome of kidney transplantation lack enough specificity to be generally accepted. Compare to classical histology, molecular assessment of renal tissue offers unbiased and technically robust approach. In this prospective 3-months' observational study procurement biopsies in 180 brain death donors will be performed. Using microarray which detect top differently regulated genes, conventional histology, urinary AKI biomarkers, renal function and clinical variables models predicting DGF and early graft scarring (IFTA, poor graft function) in recipients will be constructed. The associations of AKI in donors with distinct fibrosis atrophy and AKI molecular signals will be found. Molecular techniques and final models may help to improve the decision-making process for the acceptance of kidneys from marginal donors but more importantly, it may help clinicians to guide less toxic immunosuppression in identified problematic grafts.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2021
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 11, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2023
CompletedFirst Submitted
Initial submission to the registry
November 28, 2023
CompletedFirst Posted
Study publicly available on registry
December 14, 2023
CompletedDecember 14, 2023
December 1, 2023
1.5 years
November 28, 2023
December 12, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Kidney graft function at month 3
Kidney graft function is measured as estimated glomerular filtration in ml/s/1.73m2.
3 months
Secondary Outcomes (11)
Kidney graft survival
1 year
Delayed graft function
1 week
Fibrosis grade at month 3
3 months
Gene expression in Donor kidney
3 months
Gene expression in 3-month protocol biopsy of recipient
3 months
- +6 more secondary outcomes
Study Arms (6)
Acute kidney injury (AKI)
Donors with AKI (acute kidney injury) defined based on the results of creatinine increase and diuresis decrease before organ harvest.
no-AKI
Donors without AKI (acute kidney injury) defined based on the results of creatinine increase and diuresis decrease before organ harvest.
delayed graft function (DGF)
Donors and the paired recipients in whom the organ was transplanted in IKEM (Institute for Clinical and Experimental Medicine) who developed delayed graft function (DGF) defined as dialysis in the 1st week after transplantation.
no-DGF
Donors and the paired recipients in whom the organ was transplanted in IKEM (Institute for Clinical and Experimental Medicine) with immediate graft function (no-DGF).
Recipient IFTA
Donors and the paired recipients in whom the organ was transplanted in IKEM with 3-month protocol biopsy histology finding of IFTA≥2.
Recipient no-IFTA
Donors and the paired recipients in whom the was transplanted in IKEM with 3-month protocol biopsy histology finding of IFTA\<2.
Interventions
Biomarkers of kidney damage in donors, such as neutrophil gelatinase-associated lipocalin (NGAL), N-acetyl-beta-D-glucosaminidase (NAG), beta2-microglobulin, alpha1-microglobulin, alpha2-macroglobulin and transferrin will be measured by ELISA.
Gene expression profiling of donor kidney biopsies using Affymetrix microarray platform (PrimeView Human Gene Expression Array).
Gene expression profiling of donor kidney biopsies using Affymetrix microarray platform (PrimeView Human Gene Expression Array).
Eligibility Criteria
All DBD donors whose kidneys will be procured by IKEM transplant team either in donor hospital or at IKEM. Corresponding recipients, transplanted at IKEM will be further monitored. Patients will receive standard immunosuppression based on tacrolimus, mycophenolate mofetil and steroids along with induction (basiliximab in low risk and rATG in high-risk) according to center protocol. All procedures in transplant recipients will be routine ones, included for cause biopsies and 3M protocol biopsy (standard of care in the center).
You may qualify if:
- All DBD (donation after brain death) donors whose kidneys will be procured by transplant team of Institute for Clinical and Experimental Medicine (IKEM) in donor hospital.
- All DBD (donation after brain death) donors whose kidneys will be procured by transplant team of Institute for Clinical and Experimental Medicine (IKEM) at IKEM.
You may not qualify if:
- Donors with circulatory death
- Donors with machine perfusion
- Donors with multiorgan transplantation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Institute for Clinical and Experimental Medicine
Prague, 140 21, Czechia
Biospecimen
donor and recipient kidney biopsies, urine and blood samples of donor
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ondrej Viklicky, Prof.
Institute for Clinical and Experimental Medicine
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of Department of Nephrology and Transplant Center
Study Record Dates
First Submitted
November 28, 2023
First Posted
December 14, 2023
Study Start
June 11, 2021
Primary Completion
December 1, 2022
Study Completion
October 31, 2023
Last Updated
December 14, 2023
Record last verified: 2023-12