Clinical trial NCT06751992: Neurocognitive Function Changes With Extended-Release Tacrolimus Among Older Kidney Transplant Recipients
Official title: Neurocognitive Function Changes With Once-Daily Extended-Release Tacrolimus (Envarsus XR) Conversion Compared to Twice-Daily Immediate Release Tacrolimus Maintenance Among Older Kidney Transplant Recipients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Kidney Transplant Recipients
Old Age
Keywords: Neurocognitive function
Tacrolimus
Kidney transplant recipients
Tremor
Insomnia
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Veloxis Pharmaceuticals
First posted: 2024-12-30
Enrollment: 92
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A prospective, open-label, single-center, randomized controlled phase 4 trial
Primary purpose: PREVENTION

Brief summary: 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).


Eligibility criteria: 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

Primary outcomes:
measure: The difference in changes of neurocognitive function in intermediate-term (Total cognition composite, standard score)
timeFrame: 12 month
measure: The difference in changes of neurocognitive function in intermediate-term (Fluid composite, standard score)
timeFrame: 12 month
measure: The difference in changes of neurocognitive function in intermediate-term (Crystallized composite, standard score)
timeFrame: 12 month
measure: The difference in changes of neurocognitive function in intermediate-term (Total cognition composite, T score)
timeFrame: 12 month
measure: The difference in changes of neurocognitive function in intermediate-term (Fluid composite, T score)
timeFrame: 12 month
measure: The difference in changes of neurocognitive function in intermediate-term (Crystallized composite, T score)
timeFrame: 12 month
Secondary outcomes:
measure: The difference in changes of neurocognitive function in short-term (Total cognition composite, standard score)
timeFrame: 3 month
measure: The difference in changes of neurocognitive function in short-term (Fluid composite, standard score)
timeFrame: 3 month
measure: The difference in changes of neurocognitive function in short-term (Crystallized composite, standard score)
timeFrame: 3 month
measure: The difference in changes of neurocognitive function in short-term (Total cognition composite, T score)
timeFrame: 3 month
measure: The difference in changes of neurocognitive function in short-term (Fluid composite, T score)
timeFrame: 3 month
measure: The difference in changes of neurocognitive function in short-term (Crystallized composite, T score)
timeFrame: 3 month
measure: The changes in quality of life, measured by SONG-LP questionnaire
timeFrame: 3 month and 12 month
measure: The changes in tremor, measured by QUEST questionnaire
timeFrame: 3 month and 12 month
measure: The changes in sleep quantity, measured by a wearable device
timeFrame: 3 month and 12 month
measure: The changes in sleep quality, measured by a wearable device
timeFrame: 3 month and 12 month
Other outcomes:
measure: Subgroup analysis of primary and secondary outcomes based on age group
timeFrame: At 3 month and 12 month
measure: Subgroup analysis of primary and secondary outcomes based on gender
timeFrame: At 3 month and 12 month
measure: Subgroup analysis of primary and secondary outcomes based on education level
timeFrame: At 3 month and 12 month
measure: Subgroup analysis of primary and secondary outcomes based on the baseline cognitive function
timeFrame: At 3 month and 12 month
Locations:
city: Boston
country: United States
facility: MGH Kidney Transplant Clinic
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Leonardo V. Riella, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: