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

End Stage Renal Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03413722
• Other study ID #: STUDY00140594
• Secondary ID: CRAD001AUS211T
• Status: Recruiting
• Start date: February 1, 2018
• Est. completion date: December 1, 2021

Study information

• Verified date: March 2021
• Source: University of Kansas Medical Center
• Contact: Andrew Jurgensen
• Phone: 913-574-0895
• Email: ajurgensen[@]kumc.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 1, 2021
• Est. primary completion date: September 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• End Stage Renal Disease
• Kidney Failure, Chronic

Intervention

Drug:
• Tacrolimus
The patient's physician will prescribe drug according to standard practice.
• Everolimus
The patient's physician will prescribe drug according to standard practice.

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
University of Kansas Medical Center	Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in cognitive function		Change from Baseline to Week 12
Secondary	Change in cerebral blood flow		Change from Baseline to Week 12