MicroRNA Expression in Everolimus-based Versus Tacrolimus-based Regimens in Kidney Transplantation

March 18, 2014 updated by: Wiwat Chancharoenthana, Chulalongkorn University

MicroRNA Expression in Everolimus-based Versus Tacrolimus-based Maintenance Immunosuppressive Regimens in Kidney Transplantation

The calcineurin inhibitor drugs including cyclosporin and tacrolimus are well-known as nephrotoxicity. However, these drugs are essential for kidney transplant especially in high immunological risks. To date, however, there is an alternative regimen by using of everolimus-based which showing less toxicity than tacrolimus-based regimen by its mechanisms. Of note, this study aims to evaluate the toxicity by using microRNA profiles detection between everolimus-based and tacrolimus-based immunosuppressive regimen in kidney transplantation.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The author aims to evaluate the effects of two regimens (everolimus-based versus tacrolimus-based) in kidney transplantation recipients. Both of regimens are prescribed only in recipents who have low immunologicla risks. After informed consent, all eligible recipients will be collected blood and urine sample for microRNA profile testing during study periods.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand, 10330
        • Recruiting
        • Chulalongkorn University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients who have given informed consent to participate in the study
  • Actual eGFR > 20-25 ml/min/1.73 m2

Exclusion Criteria:

  • Multi-organ transplantation
  • Pregnancy
  • ABO incompatible blood group
  • Second, third, fouth kidney transplantation
  • HIV positive, active or carrier in any infections

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Everolimus
everolimus dosing to tough level 6-10 ng/ml
Drug: Everolimus
Everolimus dosing to target tough level 6-10 mg/ml
Experimental: Tacrolimus
Tacrolimus dosing to target tough level 5-10 ng/ml
Drug: Tacrolimus
Tacrolimus dosing to target tough level 5-10 ng/ml

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
microRNA profiles
Time Frame: 5 years
microRNA profiles including rejection and nephrotoxicity markers
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Allograft tissue pathology
Time Frame: At year 2 and 5
Pathology studies including rejection, interstitial fibrosis and tubular atrophy
At year 2 and 5

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chulalongkorn University

Investigators

  • Principal Investigator: Wiwat Chancharoenthana, MD, Msc., Chulalongkorn University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Anticipated)

December 1, 2015

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

March 18, 2014

First Submitted That Met QC Criteria

March 18, 2014

First Posted (Estimate)

March 19, 2014

Study Record Updates

Last Update Posted (Estimate)

March 19, 2014

Last Update Submitted That Met QC Criteria

March 18, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WWC-004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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