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NCT06751992PHASE4Recruiting

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

Massachusetts General Hospital

Start Date

3/17/2026

Completion Date

10/1/2027

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 Criteria

Age Range: 65 years to No maximum

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

Interventions

DRUG

Conversion to extended-release tacrolimus

DRUG

Maintenance of immediate-release tacrolimus

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Conditions

Kidney Transplant RecipientsOld Age

Locations

MGH Kidney Transplant Clinic

Boston, Massachusetts 02114

United States