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

NCT03413722 | Completed FDA Drug

• 2 other identifiers: STUDY00140594CRAD001AUS211T
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

End Stage Renal Disease

Keywords

Kidney transplant; Cognitive function

Outcome Measures

Primary Outcomes (1)

• Change in cognitive function

  Change from Baseline to Week 12

Secondary Outcomes (1)

• Change in cerebral blood flow

  Change from Baseline to Week 12

Study Arms (2)

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.

Drug: Tacrolimus; Drug: Everolimus

Control Group

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

Drug: Tacrolimus

Interventions

Tacrolimus DRUG

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

Also known as: Prograf

Control Group; Conversion Group

Everolimus DRUG

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

Conversion Group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Potential participants will be patients undergoing kidney transplant at the University of Kansas Medical Center.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Kansas Medical Center: lead
• Novartis Pharmaceuticals: collaborator

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Tacrolimus; Everolimus

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals; Sirolimus

Study Officials

• Aditi Gupta, MD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 22, 2018
• First Posted: January 29, 2018
• Study Start: February 1, 2018
• Primary Completion: August 1, 2021
• Study Completion: October 1, 2022
• Last Updated: October 22, 2024

Record last verified: 2024-10

Locations

US (1)