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New treatment option for Kidney Transplant Recipients
Official title Neurocognitive Function Changes With Extended-Release Tacrolimus Among Older Kidney Transplant Recipients
ClinicalTrials.gov ID: NCT06751992
What this study is testing
What is Conversion to extended-release tacrolimus?
Conversion to extended-release tacrolimus is an investigational medicine, being studied as a potential treatment for kidney transplant recipients.
Also referred to as Envarsus XR.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 65 and older
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.