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

Astellas

Status: Completed

Conditions: Kidney Transplantation

Treatments: Behavioral: Qualitative interviews with participants

Study type: Observational

Funder types: Industry

Identifiers

NCT03623217

ADV-KT-14-01

Details and patient eligibility

About

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).

Full 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.

Enrollment: 56 patients

Sex: All

Ages: 19 to 69 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

Selection criteria for in-depth interview subjects:

• One male or female aged 30 or over but below 40 years old.
• One male or female aged 60 or over but below 70 years old.
• One male or female with an occupation.
• One male or female without an occupation.
• Two subjects, depending on the number of medications (more or less medications) that the subject is taking.
• Participation available Period: subjects who have received tacrolimus twice daily (b.i.d) for a minimum of 6 months to a maximum of 12 months after surgery and who are within 1 month of switching to Advagraf (once daily (q.d) regimen of modified release tacrolimus).
• Subjects who understood the purpose and risks of the questionnaire development and who were well-acquainted with the contents and submitted the written consent to participate in the interview for the questionnaire development.

Selection criteria for validation stage subjects:

1. Males and females aged 19 to 65 years old.
2. Participation Available Period: the first survey is conducted on the subjects who have received tacrolimus twice daily (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 (once daily (q.d) regimen of modified release tacrolimus).
3. Subjects who understood the purpose and risks of the questionnaire development and who were well-acquainted with the contents and submitted the written consent to participate in the interview for the questionnaire development.

Exclusion Criteria:

• None.

Trial design

56 participants in 1 patient group

Kidney transplant participants receiving tacrolimus

Description:

Transplant participants who have received tacrolimus twice daily for a minimum of 6 months to a maximum of 12 months after the surgery, and who are within 1 month of switching to the once daily regimen of modified release tacrolimus.

Treatment:

Behavioral: Qualitative interviews with participants