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

Completed

• Conditions: End Stage Renal Disease
• Interventions: Drug: Tacrolimus; Drug: Everolimus

• Registration Number: NCT03413722
• Lead Sponsor: University of Kansas Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-01-22
• Study First Submitted QC: 2018-01-22
• Study First Posted: 2018-01-29
• Study Start: 2018-02-01
• Primary Completion: 2021-08-01
• Study Completion: 2022-10-01
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-18
• Last Update Posted: 2024-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Conversion Group	Tacrolimus	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.
Conversion Group	Everolimus	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.
Control Group	Tacrolimus	Kidney transplant recipients at KUMC on tacrolimus (CNI). These will be patients not planning to undergo any change in immunosuppression.

Primary Outcome Measures

Name	Time	Method
Change in cognitive function	Change from Baseline to Week 12

Secondary Outcome Measures

Name	Time	Method
Change in cerebral blood flow	Change from Baseline to Week 12

Trial Locations

Locations (1)

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States