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OpenTrials
Completed

NCT Number: NCT03413722

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

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.

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Key information

Conditions

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

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tacrolimus

Drug

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

Other names: Prograf

Everolimus

Drug

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

Primary outcomes

  1. Change in cognitive function

    Time frame: Change from Baseline to Week 12

Secondary outcomes

  1. Change in cerebral blood flow

    Time frame: Change from Baseline to Week 12

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Collaborators

  • Novartis Pharmaceuticals

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2021
Study completion
2022
First posted
Jan 29, 2018
Registry last updated
Oct 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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