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

NCT04413916 | Completed

• 1 other identifier: P20190104
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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).

Conditions

Kidney Transplant Failure and Rejection

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Association of miRNA and kidney graft function

  correlation of selected miRNAs expression with parameters of kidney graft function

  sample collection within one month of enrollement

Secondary Outcomes (1)

• Association of miRNAs expression and kidney graft rejection or disease recurrence

  2 years

Interventions

miRNA expression DIAGNOSTIC_TEST

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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%).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Medical Centre Ljubljana: lead

Study Sites (1)

University Medical Centre Ljubljana

Ljubljana, 1000, Slovenia

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serums from kidney transplant recipients

MeSH Terms

Conditions

Rejection, Psychology

Condition Hierarchy (Ancestors)

Social Behavior; Behavior

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assist. prof.

Study Record Dates

• First Submitted: May 25, 2020
• First Posted: June 4, 2020
• Study Start: January 1, 2019
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: June 4, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)