Alterations in Cognitive Function and Cerebral Blood Flow After Conversion From Immediate Release Tacrolimus to Slow Release Envarsus



Status:Recruiting
Conditions:Renal Impairment / Chronic Kidney Disease, Renal Impairment / Chronic Kidney Disease
Therapuetic Areas:Nephrology / Urology
Healthy:No
Age Range:18 - 85
Updated:1/2/2019
Start Date:October 25, 2018
End Date:November 16, 2019
Contact:Andrew Jurgensen
Email:ajurgensen@kumc.edu
Phone:913-574-0895

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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.

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.

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
We found this trial at
1
site
3901 Rainbow Blvd
Kansas City, Kansas 66160
(913) 588-5000
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