NCT02091973

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2010

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

March 18, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 19, 2014

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

March 19, 2014

Status Verified

March 1, 2014

Enrollment Period

5.5 years

First QC Date

March 18, 2014

Last Update Submit

March 18, 2014

Conditions

microRNA Profiles

Keywords

everolimustacrolimuskidney transplantationmicroRNA

Outcome Measures

Primary Outcomes (1)

  • microRNA profiles

    microRNA profiles including rejection and nephrotoxicity markers

    5 years

Secondary Outcomes (1)

  • Allograft tissue pathology

    At year 2 and 5

Study Arms (2)

Everolimus

EXPERIMENTAL

everolimus dosing to tough level 6-10 ng/ml

Drug: Everolimus

Tacrolimus

EXPERIMENTAL

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

Drug: Tacrolimus

Interventions

EverolimusDRUG

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

Everolimus
TacrolimusDRUG

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

Tacrolimus

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who have given informed consent to participate in the study
  • Actual eGFR \> 20-25 ml/min/1.73 m2

You may not qualify if:

  • Multi-organ transplantation
  • Pregnancy
  • ABO incompatible blood group
  • Second, third, fouth kidney transplantation
  • HIV positive, active or carrier in any infections

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chulalongkorn University

Bangkok, 10330, Thailand

RECRUITING

MeSH Terms

Interventions

EverolimusTacrolimus

Intervention Hierarchy (Ancestors)

SirolimusMacrolidesLactonesOrganic Chemicals

Study Officials

  • Wiwat Chancharoenthana, MD, Msc.

    Chulalongkorn University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Wiwat Chancharoenthana, MD, MSc.

CONTACT

6622564251wiwatmd@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

March 18, 2014

First Posted

March 19, 2014

Study Start

June 1, 2010

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

March 19, 2014

Record last verified: 2014-03

Locations

TH(1)