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Completed

NCT Number: NCT06171438

Molecular Markers of Acute Kidney Injury in Elderly Deceased Donors

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.

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Key information

Conditions

Kidney Transplantation Acute Kidney Injury Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Institute for Clinical and Experimental Medicine

Prague, 140 21, Czechia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • Donors with circulatory death
  • Donors with machine perfusion
  • Donors with multiorgan transplantation.

Treatment and study plan

Urine Biomarkers

Diagnostic Test

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 kidneys by microarray

Diagnostic Test

Gene expression profiling of donor kidney biopsies using Affymetrix microarray platform (PrimeView Human Gene Expression Array).

Gene expression profiling of recipient kidneys by microarray

Diagnostic Test

Gene expression profiling of donor kidney biopsies using Affymetrix microarray platform (PrimeView Human Gene Expression Array).

Primary outcomes

  1. Kidney graft function at month 3

    Time frame: 3 months

    Kidney graft function is measured as estimated glomerular filtration in ml/s/1.73m2.

Secondary outcomes

  1. Kidney graft survival

    Time frame: 1 year

    Measured as numbers of patients with graft loss censored to death.

  2. Delayed graft function

    Time frame: 1 week

    The need of dialysis in the 1st week after transplantation. Measured as numbers of patients.

  3. Fibrosis grade at month 3

    Time frame: 3 months

    Histologic result of interstitial fibrosis and atrophy at protocol biopsy. Min 0, Max 3, higher means worse

  4. Gene expression in Donor kidney

    Time frame: 3 months

    Whole transcriptome microarray profiling of wedge biopsy taken immediately after organ procurement.

  5. Gene expression in 3-month protocol biopsy of recipient

    Time frame: 3 months

    Whole transcriptome microarray profiling of 3-months protocol biopsies of recipients .

  6. Urinary biomarkers of AKI in donors before organ taking

    Time frame: 3 months

    NGAL, Neutrophil gelatinase-associated lipocalin, ng/ml.

  7. Urinary biomarkers of AKI in donors before organ taking (NAG)

    Time frame: 3 months

    NAG, N-acetyl-beta-D-glucosamine, in IU/l

  8. Urinary biomarkers of AKI in donors before organ taking (beta 2 microglobulin)

    Time frame: 3 months

    beta 2 microglobulin, in mg/l

  9. Urinary biomarkers of AKI in donors before organ taking (alfa1 microglobulin)

    Time frame: 3 months

    alfa1 microglobulin, in mg/l

  10. Urinary biomarkers of AKI in donors before organ taking (alfa2 macroglobulin)

    Time frame: 3 months

    alfa2 macroglobulin, in mg/l

  11. Urinary biomarkers of AKI in donors before organ taking (transferrin)

    Time frame: 3 months

    transferrin, in mg/l

Sponsors and collaborators

Lead sponsor

Institute for Clinical and Experimental Medicine

Other Gov

Registry information

Acronym: MoliDon

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Dec 14, 2023
Registry last updated
Dec 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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