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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03413722
Enrollment
30
Registered
2018-01-29
Start date
2018-02-01
Completion date
2022-10-01
Last updated
2024-10-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

End Stage Renal Disease

Keywords

Kidney transplant, Cognitive function

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.

Interventions

DRUGTacrolimus

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

DRUGEverolimus

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

Sponsors

Novartis Pharmaceuticals
CollaboratorINDUSTRY
University of Kansas Medical Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Change in cognitive functionChange from Baseline to Week 12

Secondary

MeasureTime frame
Change in cerebral blood flowChange from Baseline to Week 12

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026