Skip to main content
OpenTrials
Completed

NCT Number: NCT03703154

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

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.

Completed

Looking for future studies?

Notify Me

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Envarsus

Drug

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

Drug

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

Other names: Prograf

Primary outcomes

  1. Change in cognitive function using a battery of neuropsychological tests

    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.

  2. Change in cerebral blood flow

    Time frame: Change from Baseline to Week 12

    including brain blood flow response curve to exercise or cerebral reactivity

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Collaborators

  • Veloxis Pharmaceuticals

Registry information

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Oct 11, 2018
Registry last updated
Apr 27, 2021

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.