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| Name | Class |
|---|---|
| Simon Fraser University | OTHER |
| Astellas Pharma Canada, Inc. | INDUSTRY |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prograf® | Active Comparator | Prograf® is a twice daily formulation of tacrolimus |
|
| Advagraf® | Experimental | Advagraf® is a once daily formulation of tacrolimus |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| blood levels of medication | blood levels of tacrolimus will be monitored throughout the study. | 4 months |
| self-reported medication adherence | self-report medication adherence questionnaires will also be used to assess medication adherence. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Solid Organ Transplant Clinic, Vancouver General Hospital | Vancouver | British Columbia | V5Z 1M9 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36094829 | Derived | 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. | |
| 31452902 | Derived | 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. |
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| 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 |
|
|
| 4 months |
| 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 |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D055118 | Medication Adherence |
| D003863 | Depression |
| ID | Term |
|---|---|
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
| D001526 | Behavioral Symptoms |
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| ID | Term |
|---|---|
| D016559 | Tacrolimus |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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