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

Study Overview
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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.

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.

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

Conditions
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microRNA Profiles

Intervention / Treatment
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* Drug: Everolimus
* Drug: Tacrolimus


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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everolimus, tacrolimus, kidney transplantation, microRNA