Neurocognitive Function Changes With Extended-Release Tacrolimus Among Older Kidney Transplant Recipients

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

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).

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