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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02426502
Recruitment Status : Active, not recruiting
First Posted : April 27, 2015
Last Update Posted : September 26, 2019
Sponsor:
Collaborator:
Astellas Pharma Canada, Inc.
Information provided by (Responsible Party):
John Gill, University of British Columbia

Brief 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.

Condition or disease Intervention/treatment Phase
End-Stage Renal Disease Drug: Conversion to Advagraf Drug: conversion of non-immunosuppressant drugs to once daily Drug: Conversion to once daily MPA Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 76 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Once Daily Dosing to Improve Medication Adherence and Patient Satisfaction in Kidney Transplant Recipients: A Pilot Study
Study Start Date : April 2016
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Conversion to once daily dosing
The conversion to a once daily dosing regimen will be accomplished in three phases (1-conversion to Advagraf; 2-conversion of non-immunosuppressant drugs and; 3-conversion of patients taking twice daily MPA to once daily MPA). No control group.
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
Other Name: Prograf, Cyclosporine (Neoral), Advagraf

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.
Other Name: anti-hypertensive medications, non-immunosuppressant drugs

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.
Other Name: Mycophenolate Mofetil, Myfortic, Azathioprine, Prednisone




Primary Outcome Measures :
  1. Number of patients not meeting safety criteria [ Time Frame: 1 year after enrollment of the twenty-fifth participant ]
    Progression between phases will be based on assessment of safety. Patients not meeting safety criteria will not be able to progress between stages and will be withdrawn from the study.

  2. Feasibility: Number of patients successfully converted to a once daily dosing regimen [ Time Frame: 12 months ]
    The proportion of patients that can successfully be converted to a once daily regimen

  3. Feasibility: Number of patients successfully converted to a once daily dosing regimen [ Time Frame: Up to 2 years ]
    The proportion of patients that can successfully be converted to a once daily regimen


Secondary Outcome Measures :
  1. Patient Adherence to Dosing Regimen [ Time Frame: Baseline ]
    Adherence will be assessed by the Basel assessment of adherence to immunosuppressive medications scale (BAASIS)

  2. Patient Adherence to Dosing Regimen [ Time Frame: Baseline ]
    Adherence will be assessed by the percent coefficient of variation in calcineurin inhibitor drug levels.

  3. Patient Adherence to Dosing Regimen [ Time Frame: 12 months ]
    Adherence will be assessed by the Basel assessment of adherence to immunosuppressive medications scale (BAASIS)

  4. Patient Adherence to Dosing Regimen [ Time Frame: 12 months ]
    Adherence will be assessed by the percent coefficient of variation in calcineurin inhibitor drug levels.

  5. Patient Adherence to Dosing Regimen [ Time Frame: 24 months ]
    Adherence will be assessed by the percent coefficient of variation in calcineurin inhibitor drug levels.

  6. Patient Adherence to Dosing Regimen [ Time Frame: 24 months ]
    Adherence will be assessed by the Basel assessment of adherence to immunosuppressive medications scale (BAASIS)

  7. Patient Satisfaction [ Time Frame: Baseline ]
    Patient satisfaction will be assessed by survey

  8. Patient Satisfaction [ Time Frame: 12 months ]
    Patient satisfaction will be assessed by survey

  9. Patient Satisfaction [ Time Frame: 24 months ]
    Patient satisfaction will be assessed by survey



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Pediatric patients (≥ 12 years) and adult ≥ 18 years
  2. Kidney only transplant recipients ≥ 12 months post transplantation
  3. Patients prescribed calcineurin inhibitor in the form of tacrolimus, cyclosporin and/or Advagraf
  4. Patients without a PRA who have only had one transplant and are deemed clinically low risk by the principle investigator prior to approach.
  5. Patients prescribed ≤ 1.0 gram/day of mycophenolate mofetil or ≤ 720 mg/day of mycophenolate sodium continuously in the 3 months prior to the start of the study, or patients prescribed higher doses of these drugs but taking less than the prescribed dose
  6. Patients prescribed azathioprine instead of mycophenolate mofetil or mycophenolate sodium, or patients not prescribed any of these drugs.

Inclusion Criteria at British Columbia Children's Hospital:

  1. Pediatric patients ≥ 14 years old. Although the protocol has an inclusion criteria of pediatric patients of ≥ 12 years of age, we will only be approaching those ≥ 14.
  2. Kidney transplant recipient of ≥ 12 months post transplantation.

Exclusion Criteria:

  1. Unable to provide informed consent
  2. Patients who previously underwent desensitization for Human Leukocyte Antigen (HLA) or ABO incompatibility
  3. Patients with a Panel Reactive Antibody (PRA) ≥ 30% prior to transplantation
  4. Participation in another interventional study
  5. Glomerular Filtration Rate (GFR)< 25 ml/min/1.73m2
  6. Unstable allograft function defined by any of the following:

    i) Acute rejection within the preceding 6 months ii) Biopsy proven chronic humoral rejection at any time iii) Presence of donor specific antibodies at any time prior to or after transplantation iv) Biopsy evidence of de novo or recurrent glomerular disease v) Patients with evidence of declining kidney function (drop in estimated GFR ≥ 5 ml/min/1.73m2 in the previous year)

  7. Pregnancy or planned pregnancy in the next 12 months (Note: participants for the study are transplant recipients and will be aware of the inability to become pregnant while prescribed MPA. We will confirm the patient is not pregnant and not planning to become pregnant as part of screening).
  8. Patients otherwise considered medically unsuitable for enrolment by their treating physician including previous history of non-adherence.
  9. Active infection or treatment for chronic infection (for example active cytomegalovirus, polyoma virus, hepatitis B or C infection, HIV).
  10. Active malignancy (excluding non-melanoma skin cancer)
  11. Patients in whom conversion to a once daily medication regimen is not feasible because of polypharmacy.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02426502


Locations
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Canada, British Columbia
BC Children Hospital
Vancouver, British Columbia, Canada, V5Z 4H4
St. Paul's Hospital
Vancouver, British Columbia, Canada
Vancouver General Hospital
Vancouver, British Columbia, Canada
Sponsors and Collaborators
University of British Columbia
Astellas Pharma Canada, Inc.
Investigators
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Principal Investigator: John Gill, MD St. Paul's Hospital
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Responsible Party: John Gill, Assistant Professor, University of British Columbia
ClinicalTrials.gov Identifier: NCT02426502    
Other Study ID Numbers: H14-01441
First Posted: April 27, 2015    Key Record Dates
Last Update Posted: September 26, 2019
Last Verified: September 2019
Additional relevant MeSH terms:
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Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Cyclosporine
Mycophenolic Acid
Prednisone
Azathioprine
Cyclosporins
Antihypertensive Agents
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents
Calcineurin Inhibitors
Antibiotics, Antineoplastic
Antibiotics, Antitubercular
Antitubercular Agents