NCT03764670

Brief Summary

The purpose of this study is to identify the influence of genetic and clinical factors on the clinical outcomes of kidney transplant patients with tacrolimus (TAC) based immunosuppression in Taiwan.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
98

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2018

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

November 15, 2018

Completed
15 days until next milestone

Study Start

First participant enrolled

November 30, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 5, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 3, 2019

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 22, 2020

Completed
Last Updated

March 12, 2021

Status Verified

September 1, 2020

Enrollment Period

10 months

First QC Date

November 15, 2018

Last Update Submit

March 11, 2021

Conditions

Kidney Transplantation

Keywords

tacrolimusclinical outcomesgenetic polymorphismclinical factors

Outcome Measures

Primary Outcomes (2)

  • Acute rejection

    The incidence of acute rejection within the first 1 year post-transplantation, estimated with Kaplan-Meier survival analysis

    Within the first 1 year post-transplantation

  • Graft survival

    The incidence of graft loss during the follow-up time, estimated with Kaplan-Meier survival analysis

    From post-transplantation to Dec 31, 2017

Secondary Outcomes (3)

  • Patient survival

    From post-transplantation to Dec 31, 2017

  • Kidney function measured by estimated glomerular filtration rate (eGFR)

    From post-transplantation to Dec 31, 2017

  • Incidence of adverse events, including post-transplant diabetes mellitus, deterioration of liver function, cancer, infection and hyperlipidemia

    From post-transplantation to Dec 31, 2017

Eligibility Criteria

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

Kidney transplant recipients who underwent transplantation at National Taiwan University Hospital, and received tacrolimus based immunosupression

You may qualify if:

  • Kidney transplantation
  • years old
  • Receiving tacrolimus-based immunosuppressants
  • Were recruited in a previous trial

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

Location

Study Officials

  • Meng-Kun Tsai, Professor

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

November 15, 2018

First Posted

December 5, 2018

Study Start

November 30, 2018

Primary Completion

October 3, 2019

Study Completion

September 22, 2020

Last Updated

March 12, 2021

Record last verified: 2020-09

Locations

TW(1)