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Tailored medication adherence plan for Kidney Disease
N/A
Waitlist Available
Led By Marianna Leung, Pharm D
Research Sponsored by University of British Columbia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Kidney transplant candidates anticipated to undergo transplantation from a deceased or living donor within 6 months of enrolment
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights
Study Summary
This trial will compare the kidney function and rejection rates of two groups of people undergoing kidney transplants. One group will have a formal assessment of adherence to their immunosuppressant medication regime before their transplant, and the other group will have the usual care.
Eligible Conditions
- Kidney Transplant Rejection
- Kidney Disease
- Medication Adherence
- Chronic Kidney Disease
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Comparison of mean daily medication adherence between intervention and control groups over 3 months, as measured by MEMS caps.
Secondary outcome measures
Biopsy proven acute rejection (BPAR) rate
Comparison of post-transplant test results between intervention and control group
Health Literacy for intervention group only
+10 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Phase II. Intervention groupExperimental Treatment1 Intervention
Patients will be given lactose containing white- and yellow-colored gelatin capsules stored in (MEMS®) bottles for a 1-month adherence trial. Yellow-colored gelatin capsules represent tacrolimus 0.5mg capsules while white-colored gelatin capsules represent tacrolimus 1mg capsules. MEMS® is designed to record the date/time of opening and closure of the drug vial. Patients will be asked to take a certain dose and expected to remove the correct number of white and yellow capsules from respective vial at the correct time each day. Phone calls will be made to patients to change the 'dose' at various times throughout the month to mimic the frequent need to make tacrolimus dosing changes early post-transplant.Pill count and MEMS record will be reviewed at the end of the 1-month trial period to assess adherence. Patients will also undergo health literacy, cognition testing, self-efficacy tests, with a customized post-transplant plan.
Group II: Phase I. Control groupPlacebo Group1 Intervention
The standard of care will be provided to the control group pre- and post-transplant. This does not involve any direct pre-transplant assessment of medication adherence or risk factors for non-adherence.
Tacrolimus capsules will be dispensed in Medication Event Monitoring System (MEMS) caps for 3 months post-transplant for the purpose of measuring adherence after transplantation.
Patients will be asked to complete Basel Assessment of Adherence to Immunosuppressive Medication instrument (BAASIS) questionnaire and Long-term Medication Behaviour Self-efficacy Scale at 3 months after transplantation.
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Who is running the clinical trial?
University of British ColumbiaLead Sponsor
1,412 Previous Clinical Trials
2,466,485 Total Patients Enrolled
Marianna Leung, Pharm DPrincipal InvestigatorSt. Paul's Hospital
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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