Alterations in Cognitive Function and Cerebral Blood Flow After Conversion From Calcineurin Inhibitors (CNIs) to Everolimus
NCT ID: NCT03413722
Last Updated: 2024-10-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
30 participants
OBSERVATIONAL
2018-02-01
2022-10-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Conversion Group
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.
Tacrolimus
The patient's physician will prescribe drug according to standard practice.
Everolimus
The patient's physician will prescribe drug according to standard practice.
Control Group
Kidney transplant recipients at KUMC on tacrolimus (CNI). These will be patients not planning to undergo any change in immunosuppression.
Tacrolimus
The patient's physician will prescribe drug according to standard practice.
Interventions
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Tacrolimus
The patient's physician will prescribe drug according to standard practice.
Everolimus
The patient's physician will prescribe drug according to standard practice.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
85 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
University of Kansas Medical Center
OTHER
Responsible Party
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Aditi Gupta, MD
Associate Professor
Principal Investigators
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Aditi Gupta, MD
Role: PRINCIPAL_INVESTIGATOR
University of Kansas Medical Center
Locations
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University of Kansas Medical Center
Kansas City, Kansas, United States
Countries
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Other Identifiers
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CRAD001AUS211T
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
STUDY00140594
Identifier Type: -
Identifier Source: org_study_id
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