Clinical trial NCT01334333: Comparison of Medication Adherence Between Once and Twice Daily Tacrolimus in Stable Renal Transplant Recipients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Renal Disease
Renal Transplant
Keywords: kidney transplant
tacrolimus
medication adherence
depression
neuropsychological
cognition
Self-efficacy
everyday problem solving
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Simon Fraser University
name: Astellas Pharma Canada, Inc.
First posted: 2011-04-13
Enrollment: 46
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.


Eligibility criteria: Inclusion Criteria:

* a minimum of one year post renal transplant with a successful kidney graft and stable renal function (estimated glomerular filtration rate \[GFR (glomerular filtration rate)\] above 25 ml/minute per 1.73 m2).
* currently prescribed tacrolimus
* able to swallow pills
* a minimum of grade six education
* fluent in the English language.

Exclusion Criteria:

* refusal to or inability to give written informed consent.
* any visual, hearing or other sensory/motor impairments which may interfere with the testing procedures.
* have had a stroke determined to be of significant severity
* have had a head injury determined to be of significant severity
* have a current psychiatric diagnosis determined to be of significant severity
* have the presence of an acute illness (e.g., metastatic cancer), neurological disease, and other major organ failure (e.g., end stage liver disease)

Primary outcomes:
measure: electronic monitor of medication taking
timeFrame: 4 months
Secondary outcomes:
measure: blood levels of medication
timeFrame: 4 months
measure: self-reported medication adherence
timeFrame: 4 months
measure: pharmacy refill data
timeFrame: 4 months
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Solid Organ Transplant Clinic, Vancouver General Hospital
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: R. Jean Shapiro, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Simon Fraser University
name: Wendy Loken Thornton, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of British Columbia
name: Nilufar Partovi, Pharm.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Simon Fraser University
name: Theone SE Paterson, M.A.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mellon L, Doyle F, Hickey A, Ward KD, de Freitas DG, McCormick PA, O'Connell O, Conlon P. Interventions for increasing immunosuppressant medication adherence in solid organ transplant recipients. Cochrane Database Syst Rev. 2022 Sep 12;9(9):CD012854. doi: 10.1002/14651858.CD012854.pub2.
citation: Paterson TSE, Demian M, Shapiro RJ, Loken Thornton W. Impact of Once- Versus Twice-Daily Tacrolimus Dosing on Medication Adherence in Stable Renal Transplant Recipients: A Canadian Single-Center Randomized Controlled Trial. Can J Kidney Health Dis. 2019 Aug 17;6:2054358119867993. doi: 10.1177/2054358119867993. eCollection 2019.