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MiRNA in Kidney Transplantation: Association With Kidney Graft Function and Disease Process

ASSOCIATION OF miRNA WITH ALLOGRAFT FUNCTION AND EXPRESSION PROFILES PREDICTIVE OF DISEASES OCCURING AFTER KIDNEY TRANSPLANTATION

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04413916
Enrollment
100
Registered
2020-06-04
Start date
2019-01-01
Completion date
2019-12-31
Last updated
2020-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Transplant Failure and Rejection

Keywords

miRNA, kidney transplant function, kidney transplant rejection, disease recurrence, cystatin, micro RNA

Brief 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. 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.

Interventions

DIAGNOSTIC_TESTmiRNA expression

Analysis of expression of selected miRNAs (miR-29c, miR-126, miR-146a, miR-150, miR-155, miR-223) by qPCR.

Sponsors

University Medical Centre Ljubljana
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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%).

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Association of miRNA and kidney graft functionsample collection within one month of enrollementcorrelation of selected miRNAs expression with parameters of kidney graft function

Secondary

MeasureTime frameDescription
Association of miRNAs expression and kidney graft rejection or disease recurrence2 yearsCorrelation of selected miRNAs expression and kidney graft rejection or disease recurrence

Countries

Slovenia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026