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Medication Adherence Plan for Kidney Transplant Rejection

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

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.

Who is the study for?

This trial is for kidney transplant candidates expected to receive a new organ within the next 6 months. It's designed to help those who might struggle with taking their medication regularly, which is crucial for the success of the transplant.

What is being tested?

The study tests a tailored plan to improve how patients take their immunosuppressant drugs after a kidney transplant versus usual care. One group will be monitored and given a personalized adherence strategy before and after surgery; outcomes like kidney function and rejection rates will be compared.

What are the potential side effects?

Since this trial focuses on improving medication adherence rather than testing new medications, there are no direct side effects from interventions being studied. However, better adherence can reduce risks associated with not taking prescribed immunosuppressants properly.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Comparison of mean daily medication adherence between intervention and control groups over 3 months, as measured by MEMS caps.

Secondary study objectives

Biopsy proven acute rejection (BPAR) rate

Comparison of post-transplant test results between intervention and control group

Health Literacy for intervention group only

+10 more

Trial 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

1. 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. 2. 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. 3. 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.

0 / 1Eligibility criteria met