Medication Adherence Plan for Kidney Transplant Rejection

Not currently recruiting at 1 trial location

Overseen By Marianna Leung, Pharm D

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of British Columbia

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve how well patients adhere to their medication plan after a kidney transplant. Researchers seek to determine if a personalized medication adherence plan can reduce the risk of the body rejecting the new kidney. One group will practice with fake medications to prepare, while the other group will follow the usual care plan. Kidney transplant candidates expected to receive a transplant within the next six months are suitable for this trial. The study will compare kidney health and rejection rates between the two groups. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance post-transplant care for future patients.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this medication adherence plan is safe for kidney transplant patients?

Research has shown that personalized plans to help people take their medication are generally safe. These plans are crucial for ensuring patients take their medicine on time, which is vital to prevent kidney transplant rejection. Studies have found that tools like smartphone reminders can effectively improve adherence to medication schedules.

In this trial, researchers use a dummy pill to assess how well patients stick to their medication routine before receiving a real transplant. These dummy pills contain no active medicine, ensuring safety and no side effects. This method helps doctors evaluate a patient's likelihood of following their real medication plan after the transplant.

No reports of negative effects from these types of medication plans have emerged in other studies. This suggests that the treatment is well-tolerated and poses minimal risks to participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it focuses on improving medication adherence after kidney transplants through a personalized plan. Unlike standard treatments that primarily involve routine medication and monitoring, this approach uses a Medication Event Monitoring System (MEMS) to track and adjust medication intake dynamically. By mimicking real-life dosing changes and incorporating health literacy and self-efficacy assessments, this trial aims to address the psychological and behavioral aspects of medication adherence, potentially leading to better outcomes for transplant patients.

What evidence suggests that this tailored medication adherence plan is effective for preventing kidney transplant rejection?

Research has shown that having a plan to take medications as prescribed can greatly improve outcomes for kidney transplant patients. In this trial, participants in the intervention group will receive a tailored medication adherence plan. One study found that a personalized system to help patients follow their medication schedule reduced the monthly rejection rate from 1.61 to 0.88 rejections per 100 patient-months. Another study highlighted that not taking medications as directed is a major reason why kidney transplants may not last as long, especially in younger patients. Customized plans ensure patients take their necessary medications regularly, which is vital for maintaining the health of the transplanted kidney. These plans assist patients in taking their medications correctly and consistently, leading to better overall success with the transplant. ^{2 5 6 7 8}

Who Is on the Research Team?

Marianna Leung, Pharm D

Principal Investigator

St. Paul's Hospital

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am expected to have a kidney transplant within the next 6 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-transplant Assessment

Interventional group undergoes a 1-month adherence trial with mock immunosuppressant medication and various assessments including health literacy, cognition, and self-efficacy.

1 month

Multiple visits (in-person and phone calls)

Post-transplant Monitoring

Both groups receive tacrolimus capsules in MEMS caps for 3 months to measure adherence. Patients complete BAASIS and self-efficacy questionnaires.

3 months

Regular follow-up visits

Follow-up

Participants are monitored for kidney function, rejection rates, and adherence over a longer term.

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Tailored medication adherence plan

Trial Overview 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.

How Is the Trial Designed?

Group I: Phase II. Intervention group Experimental Treatment 1 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 group Placebo Group 1 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.

Who Is Running the Clinical Trial?

University of British Columbia

Lead Sponsor

Trials

1,506

Recruited

2,528,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8089037/

Transplant Regimen Adherence for Kidney Recipients ... The primary effectiveness outcome is medication adherence via pill count, secondary outcomes include self-reported adherence and clinical outcomes. Process ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0955470X24000831

Non-adherence to immunosuppressive medications in ... Non-adherence to immunosuppressive medications is considered a major contributary factor to reduced long-term graft survival, particularly in younger people.

3. ajkd.org ajkd.org/article/S0272-6386(21)00768-X/abstract

A Medication Adherence Promotion System to Reduce ... Results. The monthly rejection rate fell from 1.61 rejections per 100 patient-months in the 26 months before implementation to 0.88 rejections ...

4. jhltonline.org jhltonline.org/article/S1053-2498(17)30014-1/fulltext

Efficacy of a medication adherence enhancing intervention ... Improving outcomes of renal transplant recipients with behavioral adherence contracts: a randomized controlled trial. Am J Transplant. 2013 ...

5. amjtransplant.org amjtransplant.org/article/S1600-6135(22)10048-1/fulltext

Improving medication adherence and outcomes in adult ... Short-term kidney transplant outcomes have improved, yet long-term outcomes continue to languish, in part due to poor medication adherence (MA). Numerous ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10272095/

Factors Impacting the Medication “Adherence Landscape ... Among organ transplant recipients, medication non-adherence has dire ramifications including rejection, suboptimal organ function, disease ...

7. researchprotocols.org researchprotocols.org/2019/6/e13351/

“Smartphone Medication Adherence Saves Kidneys” for ... Few randomized controlled trials (RCTs) have been successful in improving sustained medication adherence and blood pressure control among kidney ...

8. jmir.org jmir.org/2025/1/e73520

Effectiveness of eHealth for Medication Adherence in ... This study aimed to evaluate the effectiveness of eHealth interventions in improving medication adherence among kidney transplant recipients