Actively Recruiting
Neurocognitive Function Changes With Once-Daily Extended-Release Tacrolimus Compared to Twice-Daily Immediate-Release Tacrolimus in Older Kidney Transplant Recipients
Led by Massachusetts General Hospital · Updated on 2026-05-28
92
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
Sponsors
M
Massachusetts General Hospital
Lead Sponsor
V
Veloxis Pharmaceuticals
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the neurocognitive outcomes in older kidney transplant recipients using two forms of tacrolimus: immediate-release (IR) tacrolimus (Prograf) and extended-release tacrolimus (Envarsus XR). The study aims to compare changes in brain function between those who continue taking IR tacrolimus and those who switch to the extended-release version. This trial is a randomized controlled Phase 4 study focused on patients aged 65 and older who have received a kidney transplant at least one year ago. Participants will be randomly assigned to one of two groups. One group will switch from immediate-release tacrolimus to extended-release tacrolimus at 80% of their current total daily dose. Tacrolimus levels will be checked 3 to 4 weeks after the switch to adjust dosing if needed. The other group will continue their current dose of immediate-release tacrolimus unless blood levels fall outside the target range. During the study, participants will undergo assessments of neurocognitive function at 3 and 12 months, including total cognition, fluid reasoning, and crystallized knowledge measured by standardized scores and T scores. Quality of life, tremor, and sleep patterns will also be monitored through questionnaires and wearable devices. The study will last at least 12 months, with close monitoring of kidney function and tacrolimus blood levels to ensure safety and treatment stability.
CONDITIONS
Brief Title
Neurocognitive Function Changes With Extended-Release Tacrolimus Among Older Kidney Transplant Recipients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to give informed consent for participation in the study
- Patients who have regular outpatient follow-up at the Massachusetts General Hospital transplant center
- At least 1 year since the latest kidney transplantation
- On immediate-release tacrolimus as maintenance therapy
- Stable therapeutic tacrolimus level (5-10 ng/ml) over the last 3 months or more
- Stable kidney function with less than 20% variability between the last two estimated glomerular filtration rate (eGFR) measurements
- Using English or Spanish as the primary language
You will not qualify if you...
- Dual organ transplantation
- Rejection within the last three months
- History of moderate to severe dementia (Dementia Severity Rating Scale score 19 or higher)
- History of Parkinson's disease
- Decompensated liver disease
- Active cancer
- Uncontrolled depression or anxiety
- Blindness
- Deafness
- Intellectual disabilities
- Pregnancy
- eGFR less than 15 mL/min/1.73 m2 at the time of enrollment
- Total bilirubin greater than 3.0 mg/dL
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 months
Participants receive either extended-release tacrolimus or continue immediate-release tacrolimus as part of their maintenance immunosuppressive therapy.
Visits at 3 months and 12 months for assessments
Trial Site Locations
Total: 1 location
1
MGH Kidney Transplant Clinic
Boston, Massachusetts, United States, 02114
Actively Recruiting
Research Team
L
Leonardo V. Riella, MD, PhD
A
Amelia Stocking
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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