Clinical trial NCT03703154: Alterations in Cognitive Function and Cerebral Blood Flow After Conversion From Immediate Release Tacrolimus to Slow Release Envarsus
Official title: Alterations in Cognitive Function and Cerebral Blood Flow After Conversion From Immediate Release Tacrolimus to Slow Release Envarsus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: End Stage Renal Disease
Keywords: End Stage Renal Disease
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: Veloxis Pharmaceuticals
First posted: 2018-10-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be recruited from the KUMC kidney transplant clinic. Both male and female kidney transplant recipients aged 18 to 85 will be included.

Brief summary: 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.

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.

Eligibility criteria: Inclusion Criteria:

* age between 18 and 85 years
* 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 a kidney transplant at least 12 weeks before recruitment
* 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

Primary outcomes:
measure: Change in cognitive function using a battery of neuropsychological tests
timeFrame: Change from Baseline to Week 12
measure: Change in cerebral blood flow
timeFrame: Change from Baseline to Week 12
Secondary outcomes:
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Aditi Gupta, MD
role: PRINCIPAL_INVESTIGATOR
References: