| Trial ID: | L0862 |
| Source ID: | NCT02426502
|
| Associated Drug: |
Conversion To Advagraf
|
| Title: |
Once Daily Dosing to Improve Medication Adherence and Patient Satisfaction in Kidney Transplant Recipients
|
| Acronym: |
OnceDaily
|
| Status: |
ACTIVE_NOT_RECRUITING
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
End-Stage Renal Disease
|
| Interventions: |
DRUG: Conversion to Advagraf|DRUG: conversion of non-immunosuppressant drugs to once daily|DRUG: Conversion to once daily MPA
|
| Outcome Measures: |
Primary: Number of patients not meeting safety criteria, Progression between phases will be based on assessment of safety. Patients not meeting safety criteria will not be able to progress between stages and will be withdrawn from the study., 1 year after enrollment of the twenty-fifth participant|Feasibility: Number of patients successfully converted to a once daily dosing regimen, The proportion of patients that can successfully be converted to a once daily regimen, 12 months|Feasibility: Number of patients successfully converted to a once daily dosing regimen, The proportion of patients that can successfully be converted to a once daily regimen, Up to 2 years | Secondary: Patient Adherence to Dosing Regimen, Adherence will be assessed by the Basel assessment of adherence to immunosuppressive medications scale (BAASIS), Baseline|Patient Adherence to Dosing Regimen, Adherence will be assessed by the percent coefficient of variation in calcineurin inhibitor drug levels., Baseline|Patient Adherence to Dosing Regimen, Adherence will be assessed by the Basel assessment of adherence to immunosuppressive medications scale (BAASIS), 12 months|Patient Adherence to Dosing Regimen, Adherence will be assessed by the percent coefficient of variation in calcineurin inhibitor drug levels., 12 months|Patient Adherence to Dosing Regimen, Adherence will be assessed by the percent coefficient of variation in calcineurin inhibitor drug levels., 24 months|Patient Adherence to Dosing Regimen, Adherence will be assessed by the Basel assessment of adherence to immunosuppressive medications scale (BAASIS), 24 months|Patient Satisfaction, Patient satisfaction will be assessed by survey, Baseline|Patient Satisfaction, Patient satisfaction will be assessed by survey, 12 months|Patient Satisfaction, Patient satisfaction will be assessed by survey, 24 months
|
| Sponsor/Collaborators: |
Sponsor: University of British Columbia | Collaborators: Astellas Pharma Canada, Inc.
|
| Gender: |
ALL
|
| Age: |
CHILD, ADULT, OLDER_ADULT
|
| Phases: |
|
| Enrollment: |
76
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2016-04
|
| Completion Date: |
2024-12
|
| Results First Posted: |
|
| Last Update Posted: |
2024-05-13
|
| Locations: |
BC Children Hospital, Vancouver, British Columbia, V5Z 4H4, Canada|St. Paul's Hospital, Vancouver, British Columbia, Canada|Vancouver General Hospital, Vancouver, British Columbia, Canada
|
| URL: |
https://clinicaltrials.gov/show/NCT02426502
|
