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Once Daily Dosing to Improve Medication Adherence and Patient Satisfaction in Kidney Transplant Recipients

NCT02426502 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2024-05-13

No results posted yet for this study

Summary

Patient failure to take medications as prescribed (medication non-adherence) is now identified as an important cause of kidney transplant failure. The availability of new drugs that are taken once daily may improve patient adherence compared to older drugs that had to be taken twice per day. In this study, patients will be converted to a medication schedule where all medications are taken once daily with the goal of improving patient adherence and satisfaction.

Conditions

  • End-Stage Renal Disease

Interventions

DRUG

Conversion to Advagraf

Prograf treated patients will convert to Advagraf using a 1: 1 conversion for a period of one week. The dose will then be titrated based on tacrolimus trough levels obtained 7 days after conversion. Cyclosporine (Neoral) treated patients will initiate Advagraf 0.075 mg/kg/day, 24 hours after their last cyclosporine dose. Participants will be provided with Advagraf and instructed how to start this new medication

DRUG

conversion of non-immunosuppressant drugs to once daily

* Conversion of anti-hypertensive medications: converted to once daily alternatives with the goal of maintaining blood pressure at the same or lower level prior to conversion. * Conversion of all other medications: changed to once daily formulations of the same medication or a once daily alternative.

DRUG

Conversion to once daily MPA

* Conversion to once daily MPA: Patients taking mycophenolate mofetil (MMF) will receive 1.0 gram once daily, while patients receiving Myfortic will receive 720 mg once daily. * Conversion to once daily Myfortic: Patients prescribed proton pump inhibitors (PPIs) and MMF will be switched to equivalent dose Myfortic for a period of one month prior to conversion to once daily MPA. * Patients taking azathioprine will be maintained on the same dose. * Patients will be maintained on the same prednisone dose.

Sponsors & Collaborators

  • Astellas Pharma Canada, Inc.

    collaborator INDUSTRY

  • University of British Columbia

    lead OTHER

Principal Investigators

  • John Gill, MD · St. Paul's Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2022-08-10
Completion
2024-12-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02426502 on ClinicalTrials.gov