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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02091973

Enrollment

Registered

2014-03-19

Start date

2010-06-30

Completion date

2015-12-31

Last updated

2014-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

microRNA Profiles

Keywords

everolimus, tacrolimus, kidney transplantation, microRNA

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.

Interventions

DRUGEverolimus

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

DRUGTacrolimus

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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

Design outcomes

Primary

Measure	Time frame	Description
microRNA profiles	5 years	microRNA profiles including rejection and nephrotoxicity markers

Secondary

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

Countries

Thailand

Contacts

Primary ContactWiwat Chancharoenthana, MD, MSc.

wiwatmd@hotmail.com6622564251

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026