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

Not Applicable

• Conditions: microRNA Profiles
• Interventions: Drug: Everolimus; Drug: Tacrolimus

• Registration Number: NCT02091973
• Lead Sponsor: Chulalongkorn University

Brief Summary

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

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 Timeline

• Study Start: 2010-06
• Status Verified: 2014-03
• Study First Submitted: 2014-03-18
• Study First Submitted QC: 2014-03-18
• Last Update Submitted: 2014-03-18
• Study First Posted: 2014-03-19
• Last Update Posted: 2014-03-19
• Primary Completion: 2015-12
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Everolimus	Everolimus	everolimus dosing to tough level 6-10 ng/ml
Tacrolimus	Tacrolimus	Tacrolimus dosing to target tough level 5-10 ng/ml

Primary Outcome Measures

Name	Time	Method
microRNA profiles	5 years	microRNA profiles including rejection and nephrotoxicity markers

Secondary Outcome Measures

Name	Time	Method
Allograft tissue pathology	At year 2 and 5	Pathology studies including rejection, interstitial fibrosis and tubular atrophy

Trial Locations

Locations (1)

Chulalongkorn University; 🇹🇭 Bangkok, Thailand