An observational study in Kidney Transplantation and Acute Kidney Injury, sponsored by Institute for Clinical and Experimental Medicine. Completed at 1 site in Czechia. Per ClinicalTrials.gov, last updated 2023-12-14.
Sponsored by Institute for Clinical and Experimental Medicine · Observational
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.
The aim is to create a prediction model of early clinical outcome (delayed graft function) based on donor and recipient clinical variables, donor eGFR, urinary AKI biomarkers, histology (glomerulosclerosis, interstitial fibrosis, vascular changes) and top differently regulated genes found in microarray of wedge procurement donor biopsy. Construct a model capable to predict early renal allograft scarring (IFTA>2), and impaired graft function (eGFR\<45 mL/min), as early as at 3 months. Describe renal molecular changes associated with established AKI in brain-death deceased donor and with aging.
1,595 studies on the registry are indexed under Acute Kidney Injury; 371 are open to participants now.
This study's enrollment of 200 is above the median of 150 across 773 observational studies indexed under Acute Kidney Injury.
Browse Acute Kidney Injury studies →Institute for Clinical and Experimental Medicine is the lead sponsor of 60 studies on the registry; 20 are open to participants now.
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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).
Exclusion Criteria:
Donors with AKI (acute kidney injury) defined based on the results of creatinine increase and diuresis decrease before organ harvest.
Diagnostic Test: Urine Biomarkers · Diagnostic Test: Gene expression profiling of donor kidneys by microarray · Diagnostic Test: Gene expression profiling of recipient kidneys by microarray
Donors without AKI (acute kidney injury) defined based on the results of creatinine increase and diuresis decrease before organ harvest.
Diagnostic Test: Urine Biomarkers · Diagnostic Test: Gene expression profiling of donor kidneys by microarray · Diagnostic Test: Gene expression profiling of recipient kidneys by microarray
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.
Diagnostic Test: Urine Biomarkers · Diagnostic Test: Gene expression profiling of donor kidneys by microarray · Diagnostic Test: Gene expression profiling of recipient kidneys by microarray
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).
Diagnostic Test: Urine Biomarkers · Diagnostic Test: Gene expression profiling of donor kidneys by microarray · Diagnostic Test: Gene expression profiling of recipient kidneys by microarray
Donors and the paired recipients in whom the organ was transplanted in IKEM with 3-month protocol biopsy histology finding of IFTA≥2.
Diagnostic Test: Gene expression profiling of donor kidneys by microarray · Diagnostic Test: Gene expression profiling of recipient kidneys by microarray
Donors and the paired recipients in whom the was transplanted in IKEM with 3-month protocol biopsy histology finding of IFTA\<2.
Diagnostic Test: Gene expression profiling of donor kidneys by microarray · Diagnostic Test: Gene expression profiling of recipient kidneys by microarray
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).
Kidney graft function at month 3
Kidney graft function is measured as estimated glomerular filtration in ml/s/1.73m2.
Time frame: 3 months
Kidney graft survival
Measured as numbers of patients with graft loss censored to death.
Time frame: 1 year
Delayed graft function
The need of dialysis in the 1st week after transplantation. Measured as numbers of patients.
Time frame: 1 week
Fibrosis grade at month 3
Histologic result of interstitial fibrosis and atrophy at protocol biopsy. Min 0, Max 3, higher means worse
Time frame: 3 months
Gene expression in Donor kidney
Whole transcriptome microarray profiling of wedge biopsy taken immediately after organ procurement.
Time frame: 3 months
Gene expression in 3-month protocol biopsy of recipient
Whole transcriptome microarray profiling of 3-months protocol biopsies of recipients .
Time frame: 3 months
Urinary biomarkers of AKI in donors before organ taking
NGAL, Neutrophil gelatinase-associated lipocalin, ng/ml.
Time frame: 3 months
Urinary biomarkers of AKI in donors before organ taking (NAG)
NAG, N-acetyl-beta-D-glucosamine, in IU/l
Time frame: 3 months
Urinary biomarkers of AKI in donors before organ taking (beta 2 microglobulin)
beta 2 microglobulin, in mg/l
Time frame: 3 months
Urinary biomarkers of AKI in donors before organ taking (alfa1 microglobulin)
alfa1 microglobulin, in mg/l
Time frame: 3 months
Urinary biomarkers of AKI in donors before organ taking (alfa2 macroglobulin)
alfa2 macroglobulin, in mg/l
Time frame: 3 months
Urinary biomarkers of AKI in donors before organ taking (transferrin)
transferrin, in mg/l
Time frame: 3 months
This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
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Institute for Clinical and Experimental Medicine