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

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ClinicalTrials.gov Identifier: NCT03623217
Recruitment Status : Completed
First Posted : August 9, 2018
Last Update Posted : October 3, 2018
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Korea, Inc. )

Brief 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).

Condition or disease Intervention/treatment
Kidney Transplantation Behavioral: Qualitative interviews with participants

Detailed 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.


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Study Type : Observational
Actual Enrollment : 56 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : February 24, 2015
Actual Primary Completion Date : October 17, 2017
Actual Study Completion Date : October 17, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Tacrolimus

Group/Cohort Intervention/treatment
Kidney transplant participants receiving tacrolimus
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.
Behavioral: Qualitative interviews with participants
For the development and validation of a questionnaire.




Primary Outcome Measures :
  1. Health Related Quality of Life(HRQoL) measured by the newly developed and validated Kidney Transplantation and Quality of Life(KTQoL) Questionnaire [ Time Frame: Up to a maximum of 32 months ]
    KTQoL is a transplantation-specific questionnaire to assess 'General QoL' for transplant participants after surgery and 'Specific QoL' for transplant participants after conversion from twice-daily (BID) to once-daily (QD) tacrolimus. 'General QoL' represents how good the participant's HRQoL is after a transplant surgery and 'Specific QoL' shows how good the participant's health is after conversion of medication from BID to QD. The KTQoL questionnaire consists of 24 questions, 17 for 'General Health' and 7 for 'Specific Health'. The total 'General QoL' scores range from 0-58 and it has sub-scales scores of global scale (range of 0-4), worry (range of 0-16), symptom (range of 0-28) and everyday life (range of 0-10). The total 'Specific QoL' scores range from 0-22 with no sub-scales. Higher values represent a better outcome.



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants who underwent kidney transplantation
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03623217


Locations
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Korea, Republic of
Site 1
Seoul, Korea, Republic of, 06351
Sponsors and Collaborators
Astellas Pharma Korea, Inc.
Investigators
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Study Chair: Astellas Pharma Korea, Inc. Astellas Pharma Korea, Inc.

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Responsible Party: Astellas Pharma Korea, Inc.
ClinicalTrials.gov Identifier: NCT03623217     History of Changes
Other Study ID Numbers: ADV-KT-14-01
First Posted: August 9, 2018    Key Record Dates
Last Update Posted: October 3, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas."

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Astellas Pharma Inc ( Astellas Pharma Korea, Inc. ):
Behavioral
Questionnaire development
Questionnaire
Interview with patients
Observational
Tacrolimus
Patient reported outcome tool
Validation
Kidney transplantation
Additional relevant MeSH terms:
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Tacrolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action