Alterations in Cognitive Function and Cerebral Blood Flow After Conversion From Calcineurin Inhibitors (CNIs) to Everolimus

University of Kansas

Status: Completed

Conditions: End Stage Renal Disease

Treatments: Drug: Everolimus; Drug: Tacrolimus

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03413722

CRAD001AUS211T (Other Grant/Funding Number)

STUDY00140594

Details and patient eligibility

About

The purpose of this study is to learn if changing from Tacrolimus to Everolimus will improve cognitive function by having less effect on brain blood flow.

Enrollment: 30 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• English speaking
• able to sign informed consent
• able to arrange transportation to and from study site
• without acute stroke, concussion or traumatic brain injury
• without acute medical issues at the time of participation
• At least 12 weeks post Kidney transplant surgery

Exclusion criteria

• are claustrophobic or have other contra-indication for magnetic resonance imaging (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
• taking Envarsus at the time of recruitment

Trial design

30 participants in 2 patient groups

Conversion Group

Description:

Kidney transplant recipients at the University of Kansas Medical Center (KUMC) who are currently on tacrolimus (CNI), and will be undergoing conversion to Everolimus + low dose CNI. Potential participants will be asked to participate in the study after the decision to convert CNI to Everolimus + low dose CNI has been made.

Treatment:

Drug: Tacrolimus

Drug: Everolimus

Control Group

Description:

Kidney transplant recipients at KUMC on tacrolimus (CNI). These will be patients not planning to undergo any change in immunosuppression.

Treatment:

Drug: Tacrolimus