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

Recruiting now · Phase 4

Conditions studied: Kidney Transplant Recipients, Old Age

In brief

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).

Key facts

Study ID

NCT06751992

Run by

Massachusetts General Hospital

People needed

92

Starts

2026-03-17

Expected to finish

2027-10-01

Last updated by the study team

2026-05-28

Who can join

Age: 65 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• MGH Kidney Transplant Clinic — Boston, Massachusetts, United States (enrolling)

Full record on ClinicalTrials.gov

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