Status:
WITHDRAWN
Efficacy of Envarsus XR and Digital Health Technology in Reducing Tacrolimus Fluctuation and Frequency of Dose Changes
Lead Sponsor:
Beth Israel Deaconess Medical Center
Collaborating Sponsors:
Veloxis Pharmaceuticals
Conditions:
Medication Adherence
Renal Transplant
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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...
Detailed Description
Tacrolimus is a calcineurin-inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in patients receiving allogeneic liver, kidney or heart transplants, in combination with other ...
Eligibility Criteria
Inclusion
- BIDMC adult kidney transplant recipient more than 2 years post transplant
- On tacrolimus IR regimen
- Estimated glomerular filtration rate (eGFR) \>45
- Tacrolimus dose adjustments 2 or more times in past 12 months
- Own and able to use a smart phone.
- Able to consent
Exclusion
- Prisoners
- Patients with primary language other than English, Spanish, Haitian/Creole, Mandarin
- Patients who can't swallow whole tablets or capsules.
Key Trial Info
Start Date :
June 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04711291
Start Date
June 1 2017
End Date
July 1 2023
Last Update
August 9 2024
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