Neurocognitive Function Changes With Extended-Release Tacrolimus Among Older Kidney Transplant Recipients
NCT ID: NCT06751992
Last Updated: 2025-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE4
92 participants
INTERVENTIONAL
2025-12-01
2027-10-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Envarsus XR conversion
Patients who are randomized to this group will receive extended-release tacrolimus (Envarsus XR) at 80 percent of their total daily dose of IR tacrolimus (Prograf) before the switch. Tacrolimus trough level will be obtained 3-4 weeks after the conversion to ensure appropriate dosage.
Conversion to extended-release tacrolimus
Conversion from immediate-release tacrolimus (Prograf) to extended-release tacrolimus (Envarsus XR) as a part of the maintenance immunosuppressive treatment
Prograf maintenance
Patients in the IR tacrolimus (Prograf) maintenance group will continue with their current dose of IR tacrolimus (Prograf) before enrollment unless the drug trough levels deviate from the therapeutic range.
Maintenance of immediate-release tacrolimus
Continuing immediate-release tacrolimus (Prograf) as a part of the maintenance immunosuppressive treatment
Interventions
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Conversion to extended-release tacrolimus
Conversion from immediate-release tacrolimus (Prograf) to extended-release tacrolimus (Envarsus XR) as a part of the maintenance immunosuppressive treatment
Maintenance of immediate-release tacrolimus
Continuing immediate-release tacrolimus (Prograf) as a part of the maintenance immunosuppressive treatment
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
65 Years
ALL
No
Sponsors
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Veloxis Pharmaceuticals
INDUSTRY
Massachusetts General Hospital
OTHER
Responsible Party
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Leonardo V. Riella, MD, PhD
Medical Director of Kidney Transplantation
Principal Investigators
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Leonardo V. Riella, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
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MGH Kidney Transplant Clinic
Boston, Massachusetts, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2024P000460
Identifier Type: -
Identifier Source: org_study_id
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