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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by University of British Columbia.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Simon Fraser University
Astellas Pharma Canada, Inc.
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01334333
First received: April 11, 2011
Last updated: November 22, 2011
Last verified: November 2011
  Purpose

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.

Condition Intervention Phase
Renal Disease
Renal Transplant
Drug: Tacrolimus - Prograf® twice daily formulation
Drug: Tacrolimus - Advagraf® once daily formulation
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • electronic monitor of medication taking [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    electronic bottle tops will be used to monitor medication adherence using MEMS Caps technology for a period of 4 months.


Secondary Outcome Measures:
  • blood levels of medication [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    blood levels of tacrolimus will be monitored throughout the study.

  • self-reported medication adherence [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    self-report medication adherence questionnaires will also be used to assess medication adherence.

  • pharmacy refill data [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    pharmacy refill data from the hospital pharmacy where all participants receive their medications will also be examined to determine medication adherence.


Estimated Enrollment: 100
Study Start Date: September 2011
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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®
Experimental: Advagraf®
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®

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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] 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01334333

Contacts
Contact: R. Jean Shapiro, M.D. 604-875-5950 rjshapir@interchange.ubc.ca

Locations
Canada, British Columbia
Solid Organ Transplant Clinic, Vancouver General Hospital Recruiting
Vancouver, British Columbia, Canada, V5Z 1M9
Contact: R. Jean Shapiro, M.D.    604-875-5950    rjshapir@interchange.ubc.ca   
Principal Investigator: R. Jean Shapiro, M.D.         
Principal Investigator: Wendy Loken Thornton, Ph.D.         
Principal Investigator: Nilufar Partovi, Pharm.D.         
Principal Investigator: Theone SE Paterson, M.A.         
Sub-Investigator: Paul Keown, M.D.         
Sub-Investigator: Olwyn Johnston, M.D.         
Sub-Investigator: Paula Kebarle, M.D.         
Sponsors and Collaborators
University of British Columbia
Simon Fraser University
Astellas Pharma Canada, Inc.
Investigators
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
  More Information

No publications provided

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT01334333     History of Changes
Other Study ID Numbers: H11-00446
Study First Received: April 11, 2011
Last Updated: November 22, 2011
Health Authority: Canada: Canadian Institutes of Health Research
Canada: Ethics Review Committee
Canada: Health Canada

Keywords provided by University of British Columbia:
kidney transplant
tacrolimus
medication adherence
depression
neuropsychological
cognition
Self-efficacy
everyday problem solving

Additional relevant MeSH terms:
Kidney Diseases
Urologic Diseases
Tacrolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 29, 2014