Comparison of Medication Adherence Between Once and Twice Daily Tacrolimus in Stable Renal Transplant Recipients
A critical aspect of real-world functioning following kidney transplantation involves how adherent individuals are to their medication regimens. Regardless of the possible dangers of failing to adhere to anti-rejection medications, such as increased graft rejection, studies have reported rates of non-adherence at almost 50% following renal transplant.
The Cognitive Aging Laboratory under the direction of Dr. Wendy Thornton, at Simon Fraser University, has previously identified relationships between several potentially important cognitive and psychosocial variables, and self-reported medication adherence in renal transplant recipients, including depressive symptoms, as well as everyday and traditional cognitive functioning . The possibility that changes in dosing regimens for a given medication may have an additional impact on medication adherence presents an important issue worth further exploration.
The current study will allow for more thorough delineation of the roles of psychosocial and cognitive predictors of adherence with state-of-the-art monitoring techniques. In addition, the investigators will assess whether different dosing formulations of tacrolimus impact adherence behaviors in renal transplant recipients.
The proposed research has two primary aims to examine:
- To examine the role of cognitive and psychosocial variables in predicting medication adherence in renal transplant recipients.
- To examine whether different formulations of tacrolimus (once per day dosing versus twice per day dosing) will impact medication adherence in renal transplant recipients.
|Renal Disease Renal Transplant||Drug: Tacrolimus - Prograf® twice daily formulation Drug: Tacrolimus - Advagraf® once daily formulation||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
|Official Title:||Comparison of Medication Adherence Between Once Daily Tacrolimus (Advagraf®) and Twice Daily Tacrolimus (Prograf®) Administration in Stable Renal Transplant Recipients - a Randomized Study|
- electronic monitor of medication taking [ Time Frame: 4 months ]electronic bottle tops will be used to monitor medication adherence using MEMS (medication event monitoring system) Caps technology for a period of 4 months.
- blood levels of medication [ Time Frame: 4 months ]blood levels of tacrolimus will be monitored throughout the study.
- self-reported medication adherence [ Time Frame: 4 months ]self-report medication adherence questionnaires will also be used to assess medication adherence.
- pharmacy refill data [ Time Frame: 4 months ]pharmacy refill data from the hospital pharmacy where all participants receive their medications will also be examined to determine medication adherence.
|Study Start Date:||September 2011|
|Estimated Study Completion Date:||December 2017|
|Estimated Primary Completion Date:||December 2017 (Final data collection date for primary outcome measure)|
Active Comparator: Prograf®
Prograf® is a twice daily formulation of tacrolimus
Drug: Tacrolimus - Prograf® twice daily formulation
twice daily, dosage will be as determined by best treatment for each participant, duration of study period will be 4 months for each participant
Other Name: Prograf®
Advagraf® is a once daily formulation of tacrolimus
Drug: Tacrolimus - Advagraf® once daily formulation
once daily, dosage will be as determined by best treatment for each participant, duration of study period will be 4 months for each participant
Other Name: Advagraf®
Please refer to this study by its ClinicalTrials.gov identifier: NCT01334333
|Canada, British Columbia|
|Solid Organ Transplant Clinic, Vancouver General Hospital|
|Vancouver, British Columbia, Canada, V5Z 1M9|
|Principal Investigator:||R. Jean Shapiro, M.D.||University of British Columbia|
|Principal Investigator:||Wendy Loken Thornton, Ph.D.||Simon Fraser University|
|Principal Investigator:||Nilufar Partovi, Pharm.D.||University of British Columbia|
|Principal Investigator:||Theone SE Paterson, M.A.||Simon Fraser University|