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
Massachusetts General Hospital
92 participants
Mar 17, 2026
INTERVENTIONAL
Conditions
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
Inclusion Criteria7
- 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 Criteria13
- 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
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Interventions
Conversion from immediate-release tacrolimus (Prograf) to extended-release tacrolimus (Envarsus XR) as a part of the maintenance immunosuppressive treatment
Continuing immediate-release tacrolimus (Prograf) as a part of the maintenance immunosuppressive treatment
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06751992