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

NCT01334333 | Completed Phase 4

• 1 other identifier: H11-00446
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief 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. 1.To examine the role of cognitive and psychosocial variables in predicting medication adherence in renal transplant recipients.
2. 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

Keywords

kidney transplant; tacrolimus; medication adherence; depression; neuropsychological; cognition; Self-efficacy; everyday problem solving

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• blood levels of medication

  4 months

• self-reported medication adherence

  4 months

• pharmacy refill data

  4 months

Study Arms (2)

Prograf®

ACTIVE COMPARATOR

Prograf® is a twice daily formulation of tacrolimus

Drug: Tacrolimus - Prograf® twice daily formulation

Advagraf®

EXPERIMENTAL

Advagraf® is a once daily formulation of tacrolimus

Drug: Tacrolimus - Advagraf® once daily formulation

Interventions

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

Also known as: Prograf®

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

Also known as: Advagraf®

Advagraf®

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of British Columbia: lead
• Simon Fraser University: collaborator
• Astellas Pharma Canada, Inc.: collaborator

Study Sites (1)

Solid Organ Transplant Clinic, Vancouver General Hospital

Vancouver, British Columbia, V5Z 1M9, Canada

Location

Related Publications (2)

• 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.

  PMID: 36094829 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.

  PMID: 31452902 DERIVED

MeSH Terms

Conditions

Kidney Diseases; Medication Adherence; Depression

Interventions

Tacrolimus

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; Behavioral Symptoms

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2011
• First Posted: April 13, 2011
• Study Start: November 11, 2011
• Primary Completion: October 30, 2014
• Study Completion: March 1, 2018
• Last Updated: May 17, 2018

Record last verified: 2018-05

Locations

CA (1)