Medication Adherence Clinical Trial
Official title:
Efficacy of Envarsus XR and Digital Health Technology in Reducing Tacrolimus Fluctuation and Frequency of Dose Changes
Tacrolimus is an immunosuppressive agent prescribed to prevent organ rejection in post transplant patients, in combination with other immunosuppressants. In post-kidney transplant patients, tacrolimus blood trough(peak) level must be monitored frequently, and dose adjustments must be made as necessary to keep trough level within a very narrow target range. High tacrolimus intra-patient variability(IPV) can be a marker of medication non-adherence. The presence of medication non-adherence could be due to multiple factors e.g. Forgetfulness, misunderstanding or miscommunication due to language barrier etc. Our hypothesis is using QR code technology along with extended release Tacrolimus medication will reduce tacrolimus IPV fluctuation.
Status | Not yet recruiting |
Enrollment | 66 |
Est. completion date | July 1, 2023 |
Est. primary completion date | December 31, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. BIDMC adult kidney transplant recipient more than 2 years post transplant 2. On tacrolimus IR regimen 3. Estimated glomerular filtration rate (eGFR) >45 4. Tacrolimus dose adjustments 2 or more times in past 12 months 5. Own and able to use a smart phone. 6. Able to consent Exclusion Criteria: 1. Prisoners 2. Patients with primary language other than English, Spanish, Haitian/Creole, Mandarin 3. Patients who can't swallow whole tablets or capsules. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Beth Israel Deaconess Medical Center | Veloxis Pharmaceuticals |
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* Note: There are 14 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of tacrolimus dose changes in 12 month period. | How frequent was the dose changes in 12 month follow up post transplant, excluding changes made due to change in therapeutic target. | 1 year follow up | |
Secondary | Change in number of tacrolimus dose adjustments in follow up period compared to 12 months prior to enrolment, excluding changes made due to change in therapeutic target | We will note the change in number of Tacrolimus dose adjustments in follow up period and compared the dose changes 12 months prior to enrollment. We will exclude the changes made due to change in therapeutic target. | 12 months | |
Secondary | Self-reported adherence via monthly questionnaire. | We will monitor the patient compliance with self medications among arms and note frequency of non adherence. | 12 months | |
Secondary | • Variability in tacrolimus trough levels, as checked on routine labs as part of standard care | We will monitor the fluctuations in Tacrolimus Trough levels among patients randomized to different arms and compared their variability with the one in Arm 3 | 12 months |
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