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Recruiting NCT06751992

Neurocognitive Function Changes With Extended-Release Tacrolimus Among Older Kidney Transplant Recipients

Phase IV Interventional Kidney Transplant Recipients Old Age

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Conversion to extended-release tacrolimus, Maintenance of immediate-release tacrolimus.
Who it may be relevant to
Registry conditions: Kidney Transplant Recipients, Old Age. Basic parameters: from 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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).

Interventions

  • Drug 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
  • Drug Maintenance of immediate-release tacrolimus
    Continuing immediate-release tacrolimus (Prograf) as a part of the maintenance immunosuppressive treatment

Primary outcome measures

  • The difference in changes of neurocognitive function in intermediate-term (Total cognition composite, standard score) [Time frame: 12 month]
  • The difference in changes of neurocognitive function in intermediate-term (Fluid composite, standard score) [Time frame: 12 month]
  • The difference in changes of neurocognitive function in intermediate-term (Crystallized composite, standard score) [Time frame: 12 month]
  • The difference in changes of neurocognitive function in intermediate-term (Total cognition composite, T score) [Time frame: 12 month]
  • The difference in changes of neurocognitive function in intermediate-term (Fluid composite, T score) [Time frame: 12 month]
  • The difference in changes of neurocognitive function in intermediate-term (Crystallized composite, T score) [Time frame: 12 month]
Secondary outcome measures (10)
  • The difference in changes of neurocognitive function in short-term (Total cognition composite, standard score) [Time frame: 3 month]
  • The difference in changes of neurocognitive function in short-term (Fluid composite, standard score) [Time frame: 3 month]
  • The difference in changes of neurocognitive function in short-term (Crystallized composite, standard score) [Time frame: 3 month]
  • The difference in changes of neurocognitive function in short-term (Total cognition composite, T score) [Time frame: 3 month]
  • The difference in changes of neurocognitive function in short-term (Fluid composite, T score) [Time frame: 3 month]
  • The difference in changes of neurocognitive function in short-term (Crystallized composite, T score) [Time frame: 3 month]
  • The changes in quality of life, measured by SONG-LP questionnaire [Time frame: 3 month and 12 month]
  • The changes in tremor, measured by QUEST questionnaire [Time frame: 3 month and 12 month]
  • The changes in sleep quantity, measured by a wearable device [Time frame: 3 month and 12 month]
  • The changes in sleep quality, measured by a wearable device [Time frame: 3 month and 12 month]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

United States · 1 center
  • MGH Kidney Transplant Clinic — Boston

Identifiers

NCT: NCT06751992 · 2024P000460

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗