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Cognitive Impairment and Imaging Correlates in End Stage Renal Disease

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ClinicalTrials.gov Identifier: NCT01883349
Recruitment Status : Recruiting
First Posted : June 21, 2013
Last Update Posted : March 24, 2020
Sponsor:
Information provided by (Responsible Party):
Aditi Gupta, MD, University of Kansas Medical Center

Brief Summary:
The purpose of this study is to understand cognitive impairment in end stage renal disease before and after a kidney transplant.

Condition or disease Intervention/treatment
End Stage Renal Disease Procedure: Kidney Transplant

Detailed Description:
Cognitive impairment is very common in patients with End Stage Renal Disease (ESRD). It exact mechanisms are not clear, but patients with ESRD have more cerebral white matter changes. Several studies have shown that cognitive function improves post-transplant, indicating that there may be some reversibility in the process. This study will examine the correlation between cognitive impairment and structural brain changes before and after renal transplantation. We will also study the correlation of cognitive function with serum inflammatory markers before and after transplant. These results will be compared to aged matched healthy controls without kidney disease.

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Study Type : Observational
Estimated Enrollment : 140 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Cognitive Impairment and Imaging Correlates in End Stage Renal Disease
Study Start Date : March 2013
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
ESRD patients
ESRD patients awaiting renal transplantation
Procedure: Kidney Transplant
Kidney Transplant Surgery

Control Arm
Subjects without kidney disease



Primary Outcome Measures :
  1. Change in Cognitive Function [ Time Frame: Change from Baseline to 3 Months after Renal Transplant ]
    Cognitive testing will be performed for assessment


Secondary Outcome Measures :
  1. Change in brain MRI [ Time Frame: Change from Baseline to 3 Months after Renal Transplant ]
    Brain MRI will be performed before and after transplant

  2. Change in inflammatory markers [ Time Frame: Change from Baseline to 3 months post transplant ]

Other Outcome Measures:
  1. Change in brain MRI findings and serum inflammatory markers post transplantation and its correlation with cognition [ Time Frame: Change from Baseline to 3 Months after Renal Transplant ]


Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study population will include patients from the renal transplant waiting list at University of Kansas Medical Center. They will be tested before renal transplant and 3 months after renal transplantation.
Criteria

Inclusion Criteria:

  • Pre-transplant ESRD patients between the ages of 30 and 70 years who are listed for renal transplantation
  • Able to sign pre-transplant consent on their own will
  • Have english as their native language

Exclusion Criteria:

  • Current use of antipsychotics or anti-epileptics
  • Inability to read or write which will limit their ability to perform the cognitive tests
  • Claustrophobia or inability to get MRI for other reasons
  • Unable to sign consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01883349


Contacts
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Contact: Andrew Jurgensen, BS 913-574-0895 ajurgensen@kumc.edu

Locations
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United States, Kansas
University of Kansas Medical Center Recruiting
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
Aditi Gupta, MD
Investigators
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Principal Investigator: Aditi Gupta, MD University of Kansas Medical Center
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Aditi Gupta, MD, Assistant Professor, University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT01883349    
Other Study ID Numbers: 13566
First Posted: June 21, 2013    Key Record Dates
Last Update Posted: March 24, 2020
Last Verified: March 2020
Additional relevant MeSH terms:
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Kidney Diseases
Kidney Failure, Chronic
Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency