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

• Status: Active, not recruiting
• Trial end date: 2022-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of British Columbia
• Collaborator: Astellas Pharma Canada, Inc.
• Treatments: Antihypertensive Agents; Azathioprine; Cyclosporine; Cyclosporins; Mycophenolate mofetil; Mycophenolic Acid; Prednisone; Tacrolimus

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.