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

NCT01334333 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2018-05-17

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Simon Fraser University

    collaborator OTHER

  • Astellas Pharma Canada, Inc.

    collaborator INDUSTRY

  • University of British Columbia

    lead OTHER

Principal Investigators

  • R. Jean Shapiro, M.D. · University of British Columbia

  • Wendy Loken Thornton, Ph.D. · Simon Fraser University

  • Nilufar Partovi, Pharm.D. · University of British Columbia

  • Theone SE Paterson, M.A. · Simon Fraser University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-11
Primary Completion
2014-10-30
Completion
2018-03-01

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01334333 on ClinicalTrials.gov