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

Chulalongkorn University

Status: Unknown

Conditions: microRNA Profiles

Treatments: Drug: Tacrolimus; Drug: Everolimus

Study type: Interventional

Funder types: Other

Identifiers

NCT02091973

WWC-004

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Everolimus

Experimental group

Description:

everolimus dosing to tough level 6-10 ng/ml

Treatment:

Drug: Everolimus

Tacrolimus

Experimental group

Description:

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

Treatment:

Drug: Tacrolimus