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
Conditions
Kidney Transplant RecipientsOld Age
Locations
MGH Kidney Transplant Clinic
Boston, Massachusetts 02114
United States