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

Sponsor
University of Kansas Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT03703154
Collaborator
Veloxis Pharmaceuticals (Industry)
30
Enrollment
1
Location
28.3
Actual Duration (Months)
1.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

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.

Study Design

Study Type:
Observational
Actual Enrollment :
30 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Alterations in Cognitive Function and Cerebral Blood Flow After Conversion From Immediate Release Tacrolimus to Slow Release Envarsus
Actual Study Start Date :
Oct 25, 2018
Actual Primary Completion Date :
Mar 3, 2021
Actual Study Completion Date :
Mar 3, 2021

Arms and Interventions

Arm Intervention/Treatment
Study Arm

The patients in the study arm will be converted from immediate release Tacrolimus to Envarsus. After obtaining informed consent, participants will undergo baseline tests for cognitive function and cerebral blood flow. After 12 weeks, cognition and brain blood flow will be assesses again in all enrolled patients.

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.
Control Arm

Patients in the control arm will remain on the immediate release Tacrolimus. After obtaining informed consent, participants will undergo baseline tests for cognitive function and cerebral blood flow. After 12 weeks, cognition and brain blood flow will be assesses again in all enrolled patients.

Drug: Tacrolimus
The patient's physician will prescribe drug according to standard practice.
Other Names:
  • Prograf

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    2. Change in cerebral blood flow [Change from Baseline to Week 12]

      including brain blood flow response curve to exercise or cerebral reactivity

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Kansas Medical Center Kansas City Kansas United States 66160

    Sponsors and Collaborators

    • University of Kansas Medical Center
    • Veloxis Pharmaceuticals

    Investigators

    • Principal Investigator: Aditi Gupta, MD, University of Kansas Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Aditi Gupta, MD, Associate Professor, University of Kansas Medical Center
    ClinicalTrials.gov Identifier:
    NCT03703154
    Other Study ID Numbers:
    • STUDY00142282
    First Posted:
    Oct 11, 2018
    Last Update Posted:
    Apr 27, 2021
    Last Verified:
    Apr 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Aditi Gupta, MD, Associate Professor, University of Kansas Medical Center
    End Stage Renal Disease
    Additional relevant MeSH terms:
    Kidney Diseases
    Kidney Failure, Chronic
    Tacrolimus

    Study Results

    No Results Posted as of Apr 27, 2021