- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02091973
MicroRNA Expression in Everolimus-based Versus Tacrolimus-based Regimens in Kidney Transplantation
March 18, 2014 updated by: Wiwat Chancharoenthana, Chulalongkorn University
MicroRNA Expression in Everolimus-based Versus Tacrolimus-based Maintenance Immunosuppressive Regimens in Kidney Transplantation
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Wiwat Chancharoenthana, MD, MSc.
- Phone Number: 101 6622564251
- Email: wiwatmd@hotmail.com
Study Locations
-
-
-
Bangkok, Thailand, 10330
- Recruiting
- Chulalongkorn University
-
Contact:
- Wiwat Chancharoenthana, MD, MSc
- Phone Number: 106 6622564251
- Email: wiwatmd@hotmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Everolimus
everolimus dosing to tough level 6-10 ng/ml
|
Everolimus dosing to target tough level 6-10 mg/ml
|
Experimental: Tacrolimus
Tacrolimus dosing to target tough level 5-10 ng/ml
|
Tacrolimus dosing to target tough level 5-10 ng/ml
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
microRNA profiles
Time Frame: 5 years
|
microRNA profiles including rejection and nephrotoxicity markers
|
5 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Allograft tissue pathology
Time Frame: At year 2 and 5
|
Pathology studies including rejection, interstitial fibrosis and tubular atrophy
|
At year 2 and 5
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Wiwat Chancharoenthana, MD, Msc., Chulalongkorn University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2010
Primary Completion (Anticipated)
December 1, 2015
Study Completion (Anticipated)
December 1, 2015
Study Registration Dates
First Submitted
March 18, 2014
First Submitted That Met QC Criteria
March 18, 2014
First Posted (Estimate)
March 19, 2014
Study Record Updates
Last Update Posted (Estimate)
March 19, 2014
Last Update Submitted That Met QC Criteria
March 18, 2014
Last Verified
March 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- WWC-004
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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