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OpenTrials
Completed

NCT Number: NCT01334333

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

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.

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Solid Organ Transplant Clinic, Vancouver General Hospital

Vancouver, British Columbia, V5Z 1M9, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Tacrolimus - Prograf® twice daily formulation

Drug

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®

Tacrolimus - Advagraf® once daily formulation

Drug

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®

Primary outcomes

  1. electronic monitor of medication taking

    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.

Secondary outcomes

  1. blood levels of medication

    Time frame: 4 months

    blood levels of tacrolimus will be monitored throughout the study.

  2. self-reported medication adherence

    Time frame: 4 months

    self-report medication adherence questionnaires will also be used to assess medication adherence.

  3. pharmacy refill data

    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.

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Collaborators

  • Astellas Pharma Canada, Inc.
  • Simon Fraser University

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2014
Study completion
2018
First posted
Apr 13, 2011
Registry last updated
May 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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