Efficacy of Envarsus XR and Digital Health Technology in Reducing Tacrolimus Fluctuation and Frequency of Dose Changes

• Status: Not yet recruiting
• Trial end date: 2023-07-01
• Target enrollment: 0
• Participant gender: All

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 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.

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

Details

• Lead Sponsor: Beth Israel Deaconess Medical Center
• Collaborator: Veloxis Pharmaceuticals
• Treatments: Tacrolimus

Criteria

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.