Neurocognitive Function Changes With Extended-Release Tacrolimus Among Older Kidney Transplant Recipients (Neuro-KTR)

Mass General Brigham

Status and phase: Not yet enrolling; Phase 4

Conditions: Kidney Transplant Recipients; Old Age

Treatments: Drug: Conversion to extended-release tacrolimus; Drug: Maintenance of immediate-release tacrolimus

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06751992

2024P000460

Details and patient eligibility

About

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).

Enrollment: 92 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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92 participants in 2 patient groups

Envarsus XR conversion

Experimental group

Description:

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.

Treatment:

Drug: Conversion to extended-release tacrolimus

Prograf maintenance

Active Comparator group

Description:

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.

Treatment:

Drug: Maintenance of immediate-release tacrolimus