Kidney Transplant Failure and RejectionNCT04413916
MiRNA in Kidney Transplantation: Association With Kidney Graft Function and Disease Process
An observational study of Kidney Transplant Failure and Rejection, run by University Medical Centre Ljubljana at 1 site in Slovenia.
Trial summary
MicroRNAs (miRNAs) belong to a class of small non-coding RNAs that modulate physiological and pathological processes by post-transcriptional regulation of gene expression mainly via translational inhibition of target messenger RNAs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplant Failure and Rejection
- What is being tested?
- miRNA expression
- How many people
- 100 participants
- Where
- 1 siteSlovenia
- Study dates
- 1 Jan 2019to 31 Dec 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study included 100 kidney transplant recipients (KTRs) with at least 3 months of stable kidney graft function established with estimated GFR (eGFR) according to CKD Epidemiology Collaboration equations, serum creatinine concentration (CKD-EPI Cr), serum cystatin C concentration (CKD-EPI CysC) and measured GFR with 51Cr-EDTA clearance. Evaluation of kidney graft function was subject to previous, already completed, and published study (Borštnar Š, et al. Clin Nephrol. 2019;92(6):287-292. doi:10.5414/CN109882). Serum samples from patients participating in this study (taken at the moment of 51Cr-EDTA clearance measurement) were further analyzed in the contemporary study.
Who may be able to join
- time of kidney transplantation at least 2 years before the study entry,
- stable function of the transplanted kidney during the previous 3 months (changes in s-creatinine ≤ 20%).
Who cannot join
- age less than 18 years,
- symptomatic heart failure,
- malignancy,
- pregnancy or lactation,
- acute conditions and diseases that can affect the GFR,
- newly-introduced drugs that may affect the function of the graft,
- treatment with trimethoprim-sulfamethoxazole or cimetidine,
- the presence of a pacemaker or any other electronic device in the body.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ASSOCIATION OF miRNA WITH ALLOGRAFT FUNCTION AND EXPRESSION PROFILES PREDICTIVE OF DISEASES OCCURING AFTER KIDNEY TRANSPLANTATION
MicroRNAs (miRNAs) belong to a class of small non-coding RNAs that modulate physiological and pathological processes by post-transcriptional regulation of gene expression mainly via translational inhibition of target messenger RNAs. Recently, many miRNAs were found to be involved in pathological processes that occur following kidney transplantation, like allograft rejection, de novo disease or disease recurrence after kidney transplantation. As most of the miRNAs involved in kidney diseases are extracted by urine, the diagnostic accuracy of such molecules as biomarkers is questionable.
The aim of this study is to analyze expression of selected miRNAs (miR-29c, miR-126, miR-146a, miR-150, miR-155, miR-223) and evaluate whether their regulation is associated with kidney graft function and disease processes after kidney transplantation (KTx).
Read the detailed description
MicroRNAs (miRNA) are short, endogenous non-coding RNAs involved in the modulation of gene expression mainly by inhibition of messenger RNAs translation. Recent studies have indicated association of miRNAs with pathological processes following kidney transplantation.
The aim of the study is to determine whether selected miRNAs are related to specific disease process or only reflect kidney graft function.
The study enrolled 100 Caucasian KTRs, who presented with stable renal function (as indicated by stable serum creatinine (Cr) for 3 months and whose kidney graft function was thereafter estimated with various methods, including: cystatin C concentration, three different CKD EPI equations and measured with chromium-51 ethylenediamine tetraacetic acid clearance.
Expression of 6 selected miRNAs (miR-29c, miR-126, miR-146a, miR-150, miR-155, and miR-223) was determined by qPCR using miRNA-103a, miR-191, and miR-423 as reference genes.
- Conditions
- Kidney Transplant Failure and Rejection
- Being tested
- miRNA expression
- Keywords
- miRNA, kidney transplant function, kidney transplant rejection, disease recurrence, cystatin, micro RNA
- Medical subject headings
- Rejection, Psychology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
miRNA expressionDiagnostic test
Analysis of expression of selected miRNAs (miR-29c, miR-126, miR-146a, miR-150, miR-155, miR-223) by qPCR.
What is being measured
The primary outcome is the main question the study is designed to answer.
Association of miRNA and kidney graft function
correlation of selected miRNAs expression with parameters of kidney graft function
Measured: sample collection within one month of enrollement
Secondary outcomes (1)
Association of miRNAs expression and kidney graft rejection or disease recurrence
Correlation of selected miRNAs expression and kidney graft rejection or disease recurrence
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start1 Jan 2019
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Transplant Failure and RejectionStudies of the same condition, open and under way.
- More trials run by University Medical Centre LjubljanaThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Veceric-Haler Zeljka, University Medical Centre Ljubljana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04413916
- Sponsor's protocol ID
- P20190104
- Status last verified
- May 2020
- First submitted
- 25 May 2020
- Last updated
- 4 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ASSOCIATION OF miRNA WITH ALLOGRAFT FUNCTION AND EXPRESSION PROFILES PREDICTIVE OF DISEASES OCCURING AFTER KIDNEY TRANSPLANTATION
- ClinicalTrials.gov ID
- NCT04413916
- Acronym / sponsor ID
- P20190104
- Conditions
- Kidney Transplant Failure and Rejection
- Keywords
- miRNA, kidney transplant function, kidney transplant rejection, disease recurrence, cystatin, micro RNA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 4 Jun 2020 (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.
MicroRNAs (miRNAs) belong to a class of small non-coding RNAs that modulate physiological and pathological processes by post-transcriptional regulation of gene expression mainly via translational inhibition of target messenger RNAs. Recently, many miRNAs were found to be involved in pathological processes that occur following kidney transplantation, like allograft rejection, de novo disease or disease recurrence after kidney transplantation. As most of the miRNAs involved in kidney diseases are extracted by urine, the diagnostic accuracy of such molecules as biomarkers is questionable.
The aim of this study is to analyze expression of selected miRNAs (miR-29c, miR-126, miR-146a, miR-150, miR-155, miR-223) and evaluate whether their regulation is associated with kidney graft function and disease processes after kidney transplantation (KTx).
Detailed description
MicroRNAs (miRNA) are short, endogenous non-coding RNAs involved in the modulation of gene expression mainly by inhibition of messenger RNAs translation. Recent studies have indicated association of miRNAs with pathological processes following kidney transplantation.
The aim of the study is to determine whether selected miRNAs are related to specific disease process or only reflect kidney graft function.
The study enrolled 100 Caucasian KTRs, who presented with stable renal function (as indicated by stable serum creatinine (Cr) for 3 months and whose kidney graft function was thereafter estimated with various methods, including: cystatin C concentration, three different CKD EPI equations and measured with chromium-51 ethylenediamine tetraacetic acid clearance.
Expression of 6 selected miRNAs (miR-29c, miR-126, miR-146a, miR-150, miR-155, and miR-223) was determined by qPCR using miRNA-103a, miR-191, and miR-423 as reference genes.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study included 100 kidney transplant recipients (KTRs) with at least 3 months of stable kidney graft function established with estimated GFR (eGFR) according to CKD Epidemiology Collaboration equations, serum creatinine concentration (CKD-EPI Cr), serum cystatin C concentration (CKD-EPI CysC) and measured GFR with 51Cr-EDTA clearance. Evaluation of kidney graft function was subject to previous, already completed, and published study (Borštnar Š, et al. Clin Nephrol. 2019;92(6):287-292. doi:10.5414/CN109882). Serum samples from patients participating in this study (taken at the moment of 51Cr-EDTA clearance measurement) were further analyzed in the contemporary study.
Key inclusion criteria (2 listed)
- time of kidney transplantation at least 2 years before the study entry,
- stable function of the transplanted kidney during the previous 3 months (changes in s-creatinine ≤ 20%).
Key exclusion criteria (8 listed)
- age less than 18 years,
- symptomatic heart failure,
- malignancy,
- pregnancy or lactation,
- acute conditions and diseases that can affect the GFR,
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 |
|---|---|---|
| miRNA expressionAnalysis of expression of selected miRNAs (miR-29c, miR-126, miR-146a, miR-150, miR-155, miR-223) by qPCR. | Diagnostic test | – |
Primary outcome
Association of miRNA and kidney graft function
Time frame: sample collection within one month of enrollement
correlation of selected miRNAs expression with parameters of kidney graft function
1 secondary outcome
Association of miRNAs expression and kidney graft rejection or disease recurrence
Time frame: 2 years
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 4 Jun 2020.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Transplant Failure and Rejection, run by University Medical Centre Ljubljana at 1 site in Slovenia.
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 8 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 4 Jun 2020. 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 Slovenia. 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?
Association of miRNA and kidney graft function (time frame: sample collection within one month of enrollement). 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 4 Jun 2020.