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

microRNA Profiles Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02091973
• Other study ID #: WWC-004
• Status: Recruiting
• Phase: N/A
• First received: March 18, 2014
• Last updated: March 18, 2014
• Start date: June 2010
• Est. completion date: December 2015

Study information

• Verified date: March 2014
• Source: Chulalongkorn University
• Contact: Wiwat Chancharoenthana, MD, MSc.
• Phone: 6622564251
• Email: wiwatmd[@]hotmail.com
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• microRNA Profiles

Intervention

Drug:
• Everolimus
Everolimus dosing to target tough level 6-10 mg/ml
• Tacrolimus
Tacrolimus dosing to target tough level 5-10 ng/ml

Locations

Country	Name	City	State
Thailand	Chulalongkorn University	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Chulalongkorn University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	microRNA profiles	microRNA profiles including rejection and nephrotoxicity markers	5 years	Yes
Secondary	Allograft tissue pathology	Pathology studies including rejection, interstitial fibrosis and tubular atrophy	At year 2 and 5	No