Clinical trials related to Kidney Transplant Procedure
Neurocognitive Function Changes With Once-Daily Extended-Release Tacrolimus (Envarsus XR) Conversion Compared to Twice-Daily Immediate Release Tacrolimus Maintenance Among Older Kidney Transplant Recipients
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY
The objective of this randomized controlled study is to assess the neurocognitive outcomes between individuals using immediate-release (IR) tacrolimus (Prograf®) and those who were converted to extended-release tacrolimus (Envarsus XR) among older kidney transplant recipients (KTRs).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 65
Healthy Volunteers: f
View:
• Able to give informed consent for participation in the study
• Patients who have regular outpatient follow-up at the Massachusetts General Hospital (MGH) transplant center
• ≥1 year since the latest kidney transplantation
• On IR tacrolimus as maintenance therapy
• At a stable therapeutic tacrolimus level (5-10 ng/ml) over the last ≥3 months
• Stable kidney function \[\<20% variability between the last two estimated glomerular filtration rate (eGFR)\]
• Utilizing English or Spanish as the primary language
Locations
United States
Massachusetts
MGH Kidney Transplant Clinic
RECRUITING
Boston
Contact Information
Primary
Leonardo V. Riella, MD, PhD
lriella@mgh.harvard.edu
6177240345
Backup
Amelia Stocking
astocking@mgh.harvard.edu
Time Frame
Start Date:2026-03-17
Estimated Completion Date:2027-10-01
Participants
Target number of participants:92
Treatments
Experimental: Envarsus XR conversion
Patients who are randomized to this group will receive extended-release tacrolimus (Envarsus XR) at 80 percent of their total daily dose of IR tacrolimus (Prograf) before the switch. Tacrolimus trough level will be obtained 3-4 weeks after the conversion to ensure appropriate dosage.
Active_comparator: Prograf maintenance
Patients in the IR tacrolimus (Prograf) maintenance group will continue with their current dose of IR tacrolimus (Prograf) before enrollment unless the drug trough levels deviate from the therapeutic range.