N/A
N=42
Improving Adherence in Nonadherent Kidney Transplant Patients
Medication Adherence · Kidney Transplantation
Bottom Line
View on ClinicalTrials.gov: NCT03892317 ↗Enrolled (actual)
42
Serious AEs
33.3%
Results posted
Dec 2024
Primary outcome: Primary: Change in Number of Patients Being Adherent/Non-aherent After the Intervention — 15; 30; 34; 35 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Pharmacist led medication adherence interventions (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Imperial College London
- Primary completion
- Jul 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Number of Patients Being Adherent/Non-aherent After the Intervention |
15; 30; 34; 35; 36 | — |
| PRIMARY Change in the Median IPV Before and After the Intervention |
32.03 | — |
| PRIMARY Change in Outpatient Clinic Nonattendance Rate Before and After the Intervention |
— | — |
| SECONDARY Biopsy Proven ACR / AMR |
— | — |
| SECONDARY The Number of Readmissions |
0; 12; 30 | — |
| SECONDARY Donor Specific Antibody (DSA) or Transplant Glomerulopathy |
— | — |
| SECONDARY Fibrosis, Hyalinosis, Calcineurin Inhibitor (CNI) Toxicity or Diabetic Change on Toxicity |
— | — |
| SECONDARY Graft Loss |
— | — |
| SECONDARY Death |
— | — |
| SECONDARY Serum Creatinine |
— | — |
| SECONDARY eGFR |
— | — |
| SECONDARY Proteinuria |
— | — |
| SECONDARY Haematocrit |
— | — |
| SECONDARY Haemoglobin |
— | — |
| SECONDARY Albumin |
— | — |
Summary
Organs for transplantation remain a scarce and precious resource with over 5000 patients currently on the kidney transplant waiting list. A kidney transplant costs approximately £17,000 in the first year and £5,000 per subsequent year. If the transplant fails, the patient must return to dialysis at an estimated cost of £30,800 per year or be retransplanted. While short term outcomes have improved steadily over the last 15-20 years, longer term outcomes haven't and after 10 years approximately 30% of kidney transplants have failed. Nonadherence to immunosuppressive medication is increasingly being associated with these poor long term outcomes and studies have estimated that 30- 50% of transplant patients are nonadherent to their immunosuppressive medication. The investigators want to determine whether immunosuppression medication adherence can be improved in a group of patients receiving tailored medication adherence support form a pharmacist. Adherence support will be provided for one year and will be individualised to each patient in the intervention group after identifying both their practical and perceptual barriers to adherence. The adherence interventions offered may include additional education and medication counselling, setting alarms, provision of a medication list, the use of a medications adherence app on a smart phone, reducing the number and frequency of tablets a patient takes or referral on to another health professional such as a social worker or psychologist for additional support. A range of clinical outcomes will be assessed for all patients on a regular basis in order to determine whether the provision of effective medication adherence support for the kidney transplant patients may help to optimise the long-term outcomes of these transplants
Eligibility Criteria
Inclusion Criteria
- Adult kidney transplant patients (18 years of age and above)
- Kidney transplant patients with an IPV of tacrolimus levels of greater than 18.15% in the previous 12 months
Exclusion Criteria
- Antibody incompatible transplants including patients with preformed HLA and blood group incompatible
- Previous rejection
- Donor specific antibody positive
- HIV positive patients
- Simultaneous pancreas and kidney patients
- Paediatric patients (less than 18 years of age)
Data sourced from ClinicalTrials.gov (NCT03892317). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.