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
Who can join
Ages 65 and older · All sexes
Full eligibility criteria
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
About the study
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).
What is being tested
- Conversion to extended-release tacrolimus (drug)
- Maintenance of immediate-release tacrolimus (drug)
Sponsor: Massachusetts General Hospital · Participants: 92 · Started: Mar 17, 2026
Contact the study team
- Leonardo V. Riella, MD, PhD · Phone: 6177240345
- Amelia Stocking · Phone: 617-724-1976
Official record on ClinicalTrials.gov — NCT06751992
Locations in the U.S.
| Massachusetts | MGH Kidney Transplant Clinic, Boston |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.