Alterations in Cognitive Function and Cerebral Blood Flow... | NCT03413722

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

NCT03413722

Sponsor

University of Kansas Medical Center

Status

Completed

Last Update Posted

Oct 22, 2024Actual

Enrollment

30Actual

Phase

Not provided

Conditions

End Stage Renal Disease

Interventions

Tacrolimus
Everolimus

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
CRAD001AUS211T	Other Grant/Funding Number	Novartis Pharmaceuticals

Status Module

Record Verification Date

Oct 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2018Actual

Primary Completion Date

Aug 1, 2021Actual

Completion Date

Oct 1, 2022Actual

First Submitted Date

Jan 22, 2018

First Submission Date that Met QC Criteria

Jan 22, 2018

First Posted Date

Jan 29, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 18, 2024

Last Update Posted Date

Oct 22, 2024Actual

Name	Class
Novartis Pharmaceuticals	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Tacrolimus	Drug	The patient's physician will prescribe drug according to standard practice.	Control Group Conversion Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in cognitive function		Change from Baseline to Week 12

Secondary Outcomes

Measure	Description	Time Frame
Change in cerebral blood flow		Change from Baseline to Week 12

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Aditi Gupta, MD	University of Kansas Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Kansas Medical Center		Kansas City	Kansas	66160	United States

Condition Browse Module

MeSH Terms

ID	Term
D007676	Kidney Failure, Chronic

Ancestor Terms

ID	Term
D051436	Renal Insufficiency, Chronic
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D016559	Tacrolimus
D000068338	Everolimus

Ancestor Terms

ID	Term
D018942	Macrolides
D007783	Lactones
D009930	Organic Chemicals
D020123	Sirolimus

Browse Leaves

Not provided

Browse Branches

Not provided