University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
NCT Number: NCT03703154
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.
Looking for future studies?
Notify Me18 year–85 year
All sexes
Observational
Kansas City, Kansas, 66160, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
The patient's physician will prescribe drug according to standard practice.
Other names: Prograf
Time frame: 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.
Time frame: Change from Baseline to Week 12
including brain blood flow response curve to exercise or cerebral reactivity
University of Kansas Medical Center
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06515899
Chronic Disease, Disease Attributes
Stevenage, Hertfordshire, United Kingdom
View Trial DetailsNCT03719339
Acute Cellular Graft Rejection, Antibody-mediated Rejection
La Jolla, California, United States
View Trial DetailsNCT04817774
Chronic Disease, Disease Attributes
Leuven, Belgium
View Trial DetailsNCT02984124
Chronic Disease, Disease Attributes
Chapel Hill, North Carolina, United States
View Trial Details