NCT01334333

Comparison of Medication Adherence Between Once and Twice Daily Tacrolimus in Stable Renal Transplant Recipients

Comparison of Medication Adherence Between Once Daily Tacrolimus (Advagraf®) and Twice Daily Tacrolimus (Prograf®) Administration in Stable Renal Transplant Recipients - a Randomized Study

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: University of British Columbia · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Renal Disease
• Renal Transplant

Interventions

Type	Name	Description
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
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

Timeline

• Start date: 2011-11-11
• Primary completion: 2014-10-30
• Completion: 2018-03-01
• First posted: 2011-04-13
• Last updated: 2018-05-17

Locations

1 site across 1 country: Canada