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

University of Kansas

Status: Completed

Conditions: End Stage Renal Disease

Treatments: Drug: Tacrolimus; Drug: Envarsus

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03703154

STUDY00142282

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

30 participants in 2 patient groups

Study Arm

Description:

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.

Treatment:

Drug: Envarsus

Control Arm

Description:

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.

Treatment:

Drug: Tacrolimus