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

NCT ID: NCT03703154

Last Updated: 2021-04-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-10-25
• Study Completion Date: 2021-03-03

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.

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.

Conditions

End Stage Renal Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Envarsus

Intervention Type: 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.

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.

Tacrolimus

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: DRUG

Tacrolimus

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

Intervention Type: DRUG

Other Intervention Names

Prograf

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Veloxis Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

University of Kansas Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Aditi Gupta, MD

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Aditi Gupta, MD

Role: PRINCIPAL_INVESTIGATOR

University of Kansas Medical Center

Locations

University of Kansas Medical Center

Kansas City, Kansas, United States

Countries

United States

Other Identifiers

STUDY00142282

Identifier Type: -

Identifier Source: org_study_id