Solid Organ Transplant Clinic, Vancouver General Hospital
Vancouver, British Columbia, V5Z 1M9, Canada
NCT Number: NCT01334333
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 [4]. 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:
1. To examine the role of cognitive and psychosocial variables in predicting medication adherence in renal transplant recipients. 2. To examine whether different formulations of tacrolimus (once per day dosing versus twice per day dosing) will impact medication adherence in renal transplant recipients.
Looking for future studies?
Notify Me19 year and older
All sexes
Interventional
Phase 4
Vancouver, British Columbia, V5Z 1M9, Canada
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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 names: Prograf®
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 names: Advagraf®
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.
Time frame: 4 months
blood levels of tacrolimus will be monitored throughout the study.
Time frame: 4 months
self-report medication adherence questionnaires will also be used to assess medication adherence.
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.
University of British Columbia
Other
Comparison of Medication Adherence Between Once Daily Tacrolimus (Advagraf®) and Twice Daily Tacrolimus (Prograf®) Administration in Stable Renal Transplant Recipients - a Randomized Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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