NCT06751992 · Massachusetts General Hospital
Neurocognitive Function Changes With Extended-Release Tacrolimus Among Older Kidney Transplant Recipients
(Neuro-KTR)
What this study is about
The objective of this randomly assigned 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).
View original scientific description
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).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Intellectual disabilities
- eGFR \<15 mL/min/1.73 m2 at the time of enrollment
- Total bilirubin \>3.0 mg/dL
Where
- Boston, Massachusetts
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 28, 2026 · Source of record for eligibility and locations