NCT02707822

Brief Summary

The purpose of the study is to identify factors that may influence tacrolimus (TAC) pharmacokinetics, and the impact of gene polymorphism (ABCB1, CYP3A4, CYP3A5, POR) on pharmacokinetics of TAC in Taiwanese.

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
440

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2016

Typical duration for all trials

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

January 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 9, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 14, 2016

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

March 14, 2016

Status Verified

March 1, 2016

Enrollment Period

2.9 years

First QC Date

March 9, 2016

Last Update Submit

March 9, 2016

Conditions

Kidney TransplantationLiver Transplantation

Keywords

tacrolimuspharmacokineticsgene polymorphismclinical factors

Outcome Measures

Primary Outcomes (1)

  • Dose-normalized tacrolimus concentration

    Within the first 6 months post-transplantation

Study Arms (1)

kidney or liver transplantation

Renal or liver transplant recipients with tacrolimus as immunosuppressive drugs.

Other: Clinical and genetic factors

Interventions

Clinical and genetic factorsOTHER
kidney or liver transplantation

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Renal or liver transplant recipients who underwent transplantation at National Taiwan University Hospital, and were treated with tacrolimus.

You may qualify if:

  • kidney transplants or liver transplants
  • years old
  • receiving tacrolimus as immunosuppressive drugs

You may not qualify if:

  • Human immunodeficiency virus-positive status
  • Retransplantation or multiorgan transplantation
  • non-Asian

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

Study Officials

  • Meng-Kun Tsai

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Fe-Lin Lin Wu

CONTACT

+886-2-3366 8784flwu@ntu.edu.tw

Study Design

Study Type
observational
Observational Model
CASE ONLY
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 9, 2016

First Posted

March 14, 2016

Study Start

January 1, 2016

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

March 14, 2016

Record last verified: 2016-03

Locations

TW(1)