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

Launched by MASSACHUSETTS GENERAL HOSPITAL · Dec 20, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at how different forms of a medication called tacrolimus affect the brain function of older adults who have received kidney transplants. Specifically, researchers want to compare immediate-release tacrolimus (the standard version) with an extended-release version called Envarsus XR to see if one is better for maintaining cognitive health over time.

To participate, individuals must be at least one year post-kidney transplant, currently taking the immediate-release form of tacrolimus, and have stable kidney function. They also need to be able to understand and give consent for the study, with eligibility including those who speak English or Spanish. The trial is not yet recruiting participants, but when it opens, those who join can expect regular check-ins at the Massachusetts General Hospital transplant center to monitor their health and brain function during the study. It's important to note that people with certain medical conditions, such as severe dementia or active cancer, won't be eligible to participate.

Gender

ALL

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