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

NCT02426502 | Active Not Recruiting DMC

• 1 other identifier: H14-01441
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 3

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.

Conditions

End-Stage Renal Disease

Outcome Measures

Primary Outcomes (3)

• Number of patients not meeting safety criteria

  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 Patients not meeting safety criteria will not be able to progress between stages and will be withdrawn from the study.

  1 year after enrollment of the twenty-fifth participant

• Feasibility: Number of patients successfully converted to a once daily dosing regimen

  The proportion of patients that can successfully be converted to a once daily regimen

  12 months

• Feasibility: Number of patients successfully converted to a once daily dosing regimen

  The proportion of patients that can successfully be converted to a once daily regimen

  Up to 2 years

Secondary Outcomes (9)

• Patient Adherence to Dosing Regimen

  Baseline

• Patient Adherence to Dosing Regimen

  Baseline

• Patient Adherence to Dosing Regimen

  12 months

• Patient Adherence to Dosing Regimen

  12 months

• Patient Adherence to Dosing Regimen

  24 months

Study Arms (1)

Conversion to once daily dosing

EXPERIMENTAL

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; Drug: conversion of non-immunosuppressant drugs to once daily; Drug: Conversion to once daily MPA

Interventions

Conversion to Advagraf DRUG

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

Also known as: Prograf, Cyclosporine (Neoral), Advagraf

Conversion to once daily dosing

conversion of non-immunosuppressant drugs to once daily DRUG

* 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.

Also known as: anti-hypertensive medications, non-immunosuppressant drugs

Conversion to once daily dosing

Conversion to once daily MPA DRUG

* 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.

Also known as: Mycophenolate Mofetil, Myfortic, Azathioprine, Prednisone

Conversion to once daily dosing

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Pediatric patients (≥ 12 years) and adult ≥ 18 years
• Kidney only transplant recipients ≥ 12 months post transplantation
• Patients prescribed calcineurin inhibitor in the form of tacrolimus, cyclosporin and/or Advagraf
• Patients without a PRA who have only had one transplant and are deemed clinically low risk by the principle investigator prior to approach.
• 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
• Patients prescribed azathioprine instead of mycophenolate mofetil or mycophenolate sodium, or patients not prescribed any of these drugs.
• Kidney transplant recipient of ≥ 12 months post transplantation.

You may not qualify if:

• Unable to provide informed consent
• Patients who previously underwent desensitization for Human Leukocyte Antigen (HLA) or ABO incompatibility
• Patients with a Panel Reactive Antibody (PRA) ≥ 30% prior to transplantation
• Participation in another interventional study
• Glomerular Filtration Rate (GFR)\< 25 ml/min/1.73m2
• 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)
• 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).
• Patients otherwise considered medically unsuitable for enrolment by their treating physician including previous history of non-adherence.
• Active infection or treatment for chronic infection (for example active cytomegalovirus, polyoma virus, hepatitis B or C infection, HIV).
• Active malignancy (excluding non-melanoma skin cancer)
• Patients in whom conversion to a once daily medication regimen is not feasible because of polypharmacy.

Sponsors & Collaborators

• University of British Columbia: lead
• Astellas Pharma Canada, Inc.: collaborator

Study Sites (3)

BC Children Hospital

Vancouver, British Columbia, V5Z 4H4, Canada

Location

St. Paul's Hospital

Vancouver, British Columbia, Canada

Location

Vancouver General Hospital

Vancouver, British Columbia, Canada

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Tacrolimus; Cyclosporine; Mycophenolic Acid; Azathioprine; Prednisone

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals; Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins; Caproates; Acids, Acyclic; Carboxylic Acids; Fatty Acids; Lipids; Thionucleosides; Sulfur Compounds; Mercaptopurine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds

Study Officials

• John Gill, MD

  St. Paul's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 8, 2015
• First Posted: April 27, 2015
• Study Start: April 1, 2016
• Primary Completion: August 10, 2022
• Study Completion: December 1, 2024
• Last Updated: May 13, 2024

Record last verified: 2024-05

Locations

CA (3)