Purpose

The purpose of this study is to learn if conversion from immediate release tacrolimus to Envarsus improves cerebral blood flow, brain blood flow response to exercise, and cognition.

Condition

Eligibility

Eligible Ages
Between 18 Years and 85 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • age between 18 and 85 years
  • Montreal Cognitive Assessment (MoCA) score less than 26
  • Montreal Cognitive Assessment (MoCA) score less than 26 [12]
  • English speaking (NP tests will be in English);
  • able to sign informed consent
  • able to arrange transportation to and from study sites
  • without acute stroke, concussion or traumatic brain injury
  • received the kidney transplant at least 12 weeks before recruitment
  • have a stable kidney function with serum creatinine <3mg/dl

Exclusion Criteria

  • are claustrophobic or have other contra-indication for MRI
  • have hearing or visual impairment
  • are unable to read, write, speak or understand English
  • have uncontrolled psychosis or seizure disorder or are currently using antipsychotics or anti-epileptics
  • dual organ transplant
  • oxygen-dependent chronic obstructive pulmonary disease
  • diagnosis of dementia
  • unable to perform exercise on the Nustep (muscle weakness or cardiac safety concern)
  • uncontrolled blood pressure

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
Study Arm The patients in the study arm will be converted from immediate release Tacrolimus to Envarsus. After obtaining informed consent, participants will undergo baseline tests for cognitive function and cerebral blood flow. After 12 weeks, cognition and brain blood flow will be assesses again in all enrolled patients.
  • Drug: Envarsus
    Patients will then be randomized in the ratio of 2:1 with 20 being in the study arm and 10 in the control arm. Envarsus will be prescribed by the transplant team per conversion guidelines. The transplant team will monitor drug levels, per the dosing guidelines.
Control Arm Patients in the control arm will remain on the immediate release Tacrolimus. After obtaining informed consent, participants will undergo baseline tests for cognitive function and cerebral blood flow. After 12 weeks, cognition and brain blood flow will be assesses again in all enrolled patients.
  • Drug: Tacrolimus
    The patient's physician will prescribe drug according to standard practice.
    Other names:
    • Prograf

Recruiting Locations

University of Kansas Medical Center
Kansas City, Kansas 66160

More Details

Status
Recruiting
Sponsor
University of Kansas Medical Center

Study Contact

Andrew Jurgensen
913-574-0895
ajurgensen@kumc.edu

Detailed Description

Each patient will have two study assessments: one at baseline and another one at 12 weeks after the baseline assessment. Each assessment may be divided into 2 visits to accommodate the MRI and TCD (Transcranial Doppler ultrasound). Detailed medical history will be extracted from the patients' medical records, interviews and questionnaires. We will obtain brain MRI (without gadolinium contrast) in enrolled patients. Neuropsychological test (NP) tests will include a standard battery to detect subclinical changes in cognition which can be missed by screening tests like the mini mental state exam.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.