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Quality of Life Questionnaire Validation for Patients With Changed Tacrolimus Dosing After Kidney Transplantation

Kidney Transplantation Clinical Trial

Official title:
Development and Validation of the Questionnaire in Assessing the Health-related Quality of Life of Patients Who Switch From b.i.d to q.d of Tacrolimus After Kidney Transplantation

Clinical Trial Summary

The purpose of this study is to develop and validate a questionnaire to assess the quality of life when the recipients of kidney transplantation switched their medication from tacrolimus twice daily (BID regimen) to Advagraf (once daily (QD) regimen of modified release tacrolimus).

Clinical Trial Description

This study will develop and validate a questionnaire to assess the health-related quality of life when switching from tacrolimus twice daily (b.i.d) regimen to once daily (q.d) regimen after kidney transplantation.

In-depth interviews are conducted to develop questionnaire items, and the interviewees are as follows: participants who have received tacrolimus b.i.d for a minimum of 6 months to a maximum of 12 months, and who are within 1 month of switching to Advagraf (q.d regimen of modified release tacrolimus).

The time required for the in-depth interview is approximately 30 minutes to one hour.

After questionnaire items are developed, survey participants for validation are as follows: the first survey is conducted on participants who have received tacrolimus b.i.d for a minimum of 6 months to a maximum of 12 months during the period. The second survey is conducted within one month after switching to Advagraf (q.d regimen of modified release tacrolimus).

At the validation stage, the survey using the developed questionnaire is conducted twice, once during the b.i.d. regimen and once after switching to the q.d. regimen. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03623217
Study type Observational
Source Astellas Pharma Inc
Contact
Status Completed
Phase
Start date February 24, 2015
Completion date October 17, 2017
View Details
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