Once Daily Dosing to Improve Medication Adherence and Patient Satisfaction in Kidney Transplant Recipients: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 76
- 试验地点
- 3
- 主要终点
- Feasibility: Number of patients successfully converted to a once daily dosing regimen
研究概览
简要总结
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.
详细描述
The current pilot study will first demonstrate the safety and feasibility of converting maintenance transplant recipients to a once daily regimen, while measure of patient satisfaction and adherence are secondary outcomes. The purpose of this study is to determine the safety and feasibility of converting maintenance kidney transplant recipients (i.e. those more than one year post transplantation) to a once daily drug regimen (including immunosuppressant and non-immunosuppressant drugs). We believe that conversion to a once daily (O.D.) medication regimen for both immunosuppressive and non-immunosuppressive medications will be associated with increased patient adherence and satisfaction.
Immunosuppressant non-adherence is considered the leading potentially avoidable cause of allograft failure, with non-adherent patients having a seven fold higher odds of graft failure than adherent patients. Although medication non-adherence is multi-factorial, simplification of medication requirements has been associated with improved adherence in the non-transplant setting.
There are few prospective studies examining strategies to improve immunosuppressant adherence. The proposed study has significant potential to improve medication adherence and satisfaction in kidney transplant recipients which may ultimately lead to an improvement in long-term outcomes.
The major barrier to establishing a once daily medication regimen in maintenance kidney transplant recipients (i.e. patients ≥ 12 months post transplantation) was related to the requirement to prescribe calcineurin inhibitors twice daily. The development of Advagraf (tacrolimus extended release capsules), which is approved for prevention of rejection in kidney transplant recipients, now provides an opportunity to convert patients to a once daily immunosuppressant medication regimen.
The other maintenance immunosuppressant medications used in kidney transplantation are Mycophenolic acid (MPA), azathioprine and prednisone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
- •Inclusion Criteria at British Columbia Children's Hospital:
- •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 ≥
- •Kidney transplant recipient of ≥ 12 months post transplantation.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Conversion to Advagraf (Drug)
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.
干预措施: conversion of non-immunosuppressant drugs to once daily (Drug)
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.
干预措施: Conversion to once daily MPA (Drug)
结局指标
主要结局
Feasibility: Number of patients successfully converted to a once daily dosing regimen
时间窗: Up to 2 years
The proportion of patients that can successfully be converted to a once daily regimen
Number of patients not meeting safety criteria
时间窗: 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.
次要结局
- Patient Satisfaction(24 months)
- Patient Adherence to Dosing Regimen(24 months)
研究者
John Gill
Assistant Professor
University of British Columbia