Cognitive Impairment and Imaging Correlates in End Stage Renal Disease

End Stage Renal Disease Clinical Trial

Official title:

Cognitive Impairment and Imaging Correlates in End Stage Renal Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01883349
• Other study ID #: 13566
• Status: Recruiting
• Start date: March 2013
• Est. completion date: December 2023

Study information

• Verified date: February 2021
• Source: University of Kansas Medical Center
• Contact: Andrew Jurgensen, BS
• Phone: 913-574-0895
• Email: ajurgensen[@]kumc.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• End Stage Renal Disease
• Kidney Diseases
• Kidney Failure, Chronic

Intervention

Procedure:
• Kidney Transplant
Kidney Transplant Surgery

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Kansas Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (1)

Gupta A, Lepping RJ, Yu AS, Perea RD, Honea RA, Johnson DK, Brooks WM, Burns JM. Cognitive Function and White Matter Changes Associated with Renal Transplantation. Am J Nephrol. 2016;43(1):50-7. doi: 10.1159/000444334. Epub 2016 Feb 20. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in brain MRI findings and serum inflammatory markers post transplantation and its correlation with cognition		Change from Baseline to 3 Months after Renal Transplant
Primary	Change in Cognitive Function	Cognitive testing will be performed for assessment	Change from Baseline to 3 Months after Renal Transplant
Secondary	Change in brain MRI	Brain MRI will be performed before and after transplant	Change from Baseline to 3 Months after Renal Transplant
Secondary	Change in inflammatory markers		Change from Baseline to 3 months post transplant