Kidney TransplantationMoliDonNCT06171438
Molecular Markers of Acute Kidney Injury in Elderly Deceased Donors
An observational study of Kidney Transplantation and Acute Kidney Injury, run by Institute for Clinical and Experimental Medicine at 1 site in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Kidney Transplantation, Acute Kidney Injury
- What is being tested?
- Urine Biomarkers, Gene expression profiling of donor kidneys by microarray and Gene expression profiling of recipient kidneys by microarray
- How many people
- 200 participants
- Where
- 1 siteCzechia
- Study dates
- 11 Jun 2021to 31 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 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).
Who may be able to join
- 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.
Who cannot join
- Donors with circulatory death
- Donors with machine perfusion
- Donors with multiorgan transplantation.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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.
- Conditions
- Kidney Transplantation, Acute Kidney Injury
- Being tested
- Urine Biomarkers, Gene expression profiling of donor kidneys by microarray, Gene expression profiling of recipient kidneys by microarray
- Keywords
- kidney transplantation, donor kidney, microarray
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Urine BiomarkersDiagnostic 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 microarrayDiagnostic test
Gene expression profiling of donor kidney biopsies using Affymetrix microarray platform (PrimeView Human Gene Expression Array).
Gene expression profiling of recipient kidneys by microarrayDiagnostic test
Gene expression profiling of donor kidney biopsies using Affymetrix microarray platform (PrimeView Human Gene Expression Array).
| Study group | Role | What they receive |
|---|---|---|
| Acute kidney injury (AKI) | Donors with AKI (acute kidney injury) defined based on the results of creatinine increase and diuresis decrease before organ harvest. Receives: Diagnostic Test: Urine Biomarkers; Diagnostic Test: Gene expression profiling of donor kidneys by microarray; Diagnostic Test: Gene expression profiling of recipient kidneys by microarray | |
| no-AKI | Donors without AKI (acute kidney injury) defined based on the results of creatinine increase and diuresis decrease before organ harvest. Receives: Diagnostic Test: Urine Biomarkers; Diagnostic Test: Gene expression profiling of donor kidneys by microarray; Diagnostic Test: Gene expression profiling of recipient kidneys by microarray | |
| 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. Receives: Diagnostic Test: Urine Biomarkers; Diagnostic Test: Gene expression profiling of donor kidneys by microarray; Diagnostic Test: Gene expression profiling of recipient kidneys by microarray | |
| 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). Receives: Diagnostic Test: Urine Biomarkers; Diagnostic Test: Gene expression profiling of donor kidneys by microarray; Diagnostic Test: Gene expression profiling of recipient kidneys by microarray | |
| 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. Receives: Diagnostic Test: Gene expression profiling of donor kidneys by microarray; Diagnostic Test: Gene expression profiling of recipient kidneys by microarray | |
| 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. Receives: Diagnostic Test: Gene expression profiling of donor kidneys by microarray; Diagnostic Test: Gene expression profiling of recipient kidneys by microarray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kidney graft function at month 3
Kidney graft function is measured as estimated glomerular filtration in ml/s/1.73m2.
Measured: 3 months
Secondary outcomes (11)
Kidney graft survival
Measured as numbers of patients with graft loss censored to death.
Measured: 1 year
Delayed graft function
The need of dialysis in the 1st week after transplantation. Measured as numbers of patients.
Measured: 1 week
Fibrosis grade at month 3
Histologic result of interstitial fibrosis and atrophy at protocol biopsy. Min 0, Max 3, higher means worse
Measured: 3 months
Gene expression in Donor kidney
Whole transcriptome microarray profiling of wedge biopsy taken immediately after organ procurement.
Measured: 3 months
Gene expression in 3-month protocol biopsy of recipient
Whole transcriptome microarray profiling of 3-months protocol biopsies of recipients .
Measured: 3 months
Urinary biomarkers of AKI in donors before organ taking
NGAL, Neutrophil gelatinase-associated lipocalin, ng/ml.
Measured: 3 months
Urinary biomarkers of AKI in donors before organ taking (NAG)
NAG, N-acetyl-beta-D-glucosamine, in IU/l
Measured: 3 months
Urinary biomarkers of AKI in donors before organ taking (beta 2 microglobulin)
beta 2 microglobulin, in mg/l
Measured: 3 months
Urinary biomarkers of AKI in donors before organ taking (alfa1 microglobulin)
alfa1 microglobulin, in mg/l
Measured: 3 months
Urinary biomarkers of AKI in donors before organ taking (alfa2 macroglobulin)
alfa2 macroglobulin, in mg/l
Measured: 3 months
Urinary biomarkers of AKI in donors before organ taking (transferrin)
transferrin, in mg/l
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2023
- Study start11 Jun 2021
- Primary completion1 Dec 2022
- Study completion31 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney TransplantationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute for Clinical and Experimental Medicine
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Prof. Ondřej Viklický, M.D., Ph.D., Institute for Clinical and Experimental Medicine
- Investigators
- Ondrej Viklicky, Prof., Principal investigator, Institute for Clinical and Experimental Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06171438
- Sponsor's protocol ID
- G339-2021
- Acronym
- MoliDon
- Status last verified
- Dec 2023
- First submitted
- 28 Nov 2023
- Last updated
- 14 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Markers of Acute Kidney Injury in Elderly Deceased Donors
- ClinicalTrials.gov ID
- NCT06171438
- Acronym / sponsor ID
- MoliDon / G339-2021
- Conditions
- Kidney Transplantation, Acute Kidney Injury
- Keywords
- kidney transplantation, donor kidney, microarray
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Institute for Clinical and Experimental MedicineOther government
- Study start
- 11 Jun 2021 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 14 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Acute kidney injury (AKI) | – | Diagnostic Test: Urine Biomarkers, Diagnostic Test: Gene expression profiling of donor kidneys by microarray, Diagnostic Test: Gene expression profiling of recipient kidneys by microarrayDonors with AKI (acute kidney injury) defined based on the results of creatinine increase and diuresis decrease before organ harvest. |
| no-AKI | – | Diagnostic Test: Urine Biomarkers, Diagnostic Test: Gene expression profiling of donor kidneys by microarray, Diagnostic Test: Gene expression profiling of recipient kidneys by microarrayDonors without AKI (acute kidney injury) defined based on the results of creatinine increase and diuresis decrease before organ harvest. |
| delayed graft function (DGF) | – | Diagnostic Test: Urine Biomarkers, Diagnostic Test: Gene expression profiling of donor kidneys by microarray, Diagnostic Test: Gene expression profiling of recipient kidneys by microarrayDonors 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 | – | Diagnostic Test: Urine Biomarkers, Diagnostic Test: Gene expression profiling of donor kidneys by microarray, Diagnostic Test: Gene expression profiling of recipient kidneys by microarrayDonors 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 | – | Diagnostic Test: Gene expression profiling of donor kidneys by microarray, Diagnostic Test: Gene expression profiling of recipient kidneys by microarrayDonors 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 | – | Diagnostic Test: Gene expression profiling of donor kidneys by microarray, Diagnostic Test: Gene expression profiling of recipient kidneys by microarrayDonors and the paired recipients in whom the was transplanted in IKEM with 3-month protocol biopsy histology finding of IFTA<2. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 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).
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- Donors with circulatory death
- Donors with machine perfusion
- Donors with multiorgan transplantation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Urine BiomarkersBiomarkers 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. | Diagnostic test | Acute kidney injury (AKI), delayed graft function (DGF), no-AKI, no-DGF |
| Gene expression profiling of donor kidneys by microarrayGene expression profiling of donor kidney biopsies using Affymetrix microarray platform (PrimeView Human Gene Expression Array). | Diagnostic test | Acute kidney injury (AKI), Recipient IFTA, Recipient no-IFTA, delayed graft function (DGF), no-AKI, no-DGF |
| Gene expression profiling of recipient kidneys by microarrayGene expression profiling of donor kidney biopsies using Affymetrix microarray platform (PrimeView Human Gene Expression Array). | Diagnostic test | Acute kidney injury (AKI), Recipient IFTA, Recipient no-IFTA, delayed graft function (DGF), no-AKI, no-DGF |
Primary outcome
Kidney graft function at month 3
Time frame: 3 months
Kidney graft function is measured as estimated glomerular filtration in ml/s/1.73m2.
11 secondary outcomes
Kidney graft survival
Time frame: 1 year
Delayed graft function
Time frame: 1 week
Fibrosis grade at month 3
Time frame: 3 months
Gene expression in Donor kidney
Time frame: 3 months
Gene expression in 3-month protocol biopsy of recipient
Time frame: 3 months
Urinary biomarkers of AKI in donors before organ taking
Time frame: 3 months
Urinary biomarkers of AKI in donors before organ taking (NAG)
Time frame: 3 months
Urinary biomarkers of AKI in donors before organ taking (beta 2 microglobulin)
Time frame: 3 months
Urinary biomarkers of AKI in donors before organ taking (alfa1 microglobulin)
Time frame: 3 months
Urinary biomarkers of AKI in donors before organ taking (alfa2 macroglobulin)
Time frame: 3 months
Urinary biomarkers of AKI in donors before organ taking (transferrin)
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ondrej Viklicky, Prof. principal investigator
Institute for Clinical and Experimental Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Transplantation and Acute Kidney Injury, run by Institute for Clinical and Experimental Medicine at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Kidney graft function at month 3 (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2023.