End Stage Renal Disease
Conditions
Keywords
End Stage Renal Disease
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.
Interventions
DRUGEnvarsus
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.
DRUGTacrolimus
The patient's physician will prescribe drug according to standard practice.
Sponsors
Veloxis Pharmaceuticals
University of Kansas Medical Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in cognitive function using a battery of neuropsychological tests | Change from Baseline to Week 12 | Battery aggregate scores include such tests as: Mini Mental Sate Exam, Montreal Cognitive Assessment, Digit Span, Logical Memory, Category Fluency, Trail Making, Digit Symbol, Block Design, Stroop, Buschke Free and Cued Reminding Test. |
| Change in cerebral blood flow | Change from Baseline to Week 12 | including brain blood flow response curve to exercise or cerebral reactivity |
Countries
United States
Outcome results
None listed