Neurocognitive Function Changes With Extended-Release Tacrolimus Among Older Kidney Transplant Recipients
Purpose
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).
Conditions
- Kidney Transplant Recipients
- Old Age
Eligibility
- Eligible Ages
- Over 65 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
Exclusion Criteria
- Dual organ transplantation - Rejection within the last three months - History of moderate to severe dementia (defined by Dementia Severity Rating Scale ≥19) - History of Parkinson's disease - Decompensated liver disease - Active cancer - Uncontrolled depression or anxiety - Blindness - Deafness - Intellectual disabilities - Pregnancy - eGFR <15 mL/min/1.73 m2 at the time of enrollment - Total bilirubin >3.0 mg/dL
Study Design
- Phase
- Phase 4
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- A prospective, open-label, single-center, randomized controlled phase 4 trial
- Primary Purpose
- Prevention
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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. |
|
Recruiting Locations
MGH Kidney Transplant Clinic
Boston, Massachusetts 02114
Boston, Massachusetts 02114
More Details
- Status
- Recruiting
- Sponsor
- Massachusetts General Hospital