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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2015-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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microRNA Profiles

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Everolimus

everolimus dosing to tough level 6-10 ng/ml

Group Type EXPERIMENTAL

Everolimus

Intervention Type DRUG

Everolimus dosing to target tough level 6-10 mg/ml

Tacrolimus

Tacrolimus dosing to target tough level 5-10 ng/ml

Group Type EXPERIMENTAL

Tacrolimus

Intervention Type DRUG

Tacrolimus dosing to target tough level 5-10 ng/ml

Interventions

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Everolimus

Everolimus dosing to target tough level 6-10 mg/ml

Intervention Type DRUG

Tacrolimus

Tacrolimus dosing to target tough level 5-10 ng/ml

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No