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

Renal Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01334333
• Other study ID #: H11-00446
• Status: Completed
• Phase: Phase 4
• Start date: November 11, 2011
• Est. completion date: March 1, 2018

Study information

• Verified date: May 2018
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: March 1, 2018
• Est. primary completion date: October 30, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Renal Disease
• Renal Transplant

Intervention

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
• 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

Locations

Country	Name	City	State
Canada	Solid Organ Transplant Clinic, Vancouver General Hospital	Vancouver	British Columbia

Sponsors (3)

Lead Sponsor	Collaborator
University of British Columbia	Astellas Pharma Canada, Inc., Simon Fraser University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	electronic monitor of medication taking	electronic bottle tops will be used to monitor medication adherence using MEMS (medication event monitoring system) Caps technology for a period of 4 months.	4 months
Secondary	blood levels of medication	blood levels of tacrolimus will be monitored throughout the study.	4 months
Secondary	self-reported medication adherence	self-report medication adherence questionnaires will also be used to assess medication adherence.	4 months
Secondary	pharmacy refill data	pharmacy refill data from the hospital pharmacy where all participants receive their medications will also be examined to determine medication adherence.	4 months