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

End Stage Renal Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03703154
• Other study ID #: STUDY00142282
• Status: Completed
• Start date: October 25, 2018
• Est. completion date: March 3, 2021

Study information

• Verified date: April 2021
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 3, 2021
• Est. primary completion date: March 3, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• End Stage Renal Disease
• Kidney Diseases
• Kidney Failure, Chronic

Intervention

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.
• Tacrolimus
The patient's physician will prescribe drug according to standard practice.

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
University of Kansas Medical Center	Veloxis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in cognitive function using a battery of neuropsychological tests	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 from Baseline to Week 12
Primary	Change in cerebral blood flow	including brain blood flow response curve to exercise or cerebral reactivity	Change from Baseline to Week 12