- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01883349
Cognitive Impairment and Imaging Correlates in End Stage Renal Disease
February 4, 2021 updated by: University of Kansas Medical Center
The purpose of this study is to understand cognitive impairment in end stage renal disease before and after a kidney transplant.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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.
Study Type
Observational
Enrollment (Anticipated)
140
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Andrew Jurgensen, BS
- Phone Number: 913-574-0895
- Email: ajurgensen@kumc.edu
Study Locations
-
-
Kansas
-
Kansas City, Kansas, United States, 66160
- Recruiting
- University of Kansas Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
ESRD patients
ESRD patients awaiting renal transplantation
|
Kidney Transplant Surgery
|
Control Arm
Subjects without kidney disease
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Cognitive Function
Time Frame: Change from Baseline to 3 Months after Renal Transplant
|
Cognitive testing will be performed for assessment
|
Change from Baseline to 3 Months after Renal Transplant
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in brain MRI
Time Frame: Change from Baseline to 3 Months after Renal Transplant
|
Brain MRI will be performed before and after transplant
|
Change from Baseline to 3 Months after Renal Transplant
|
Change in inflammatory markers
Time Frame: Change from Baseline to 3 months post transplant
|
Change from Baseline to 3 months post transplant
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
Change from Baseline to 3 Months after Renal Transplant
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Aditi Gupta, MD, University of Kansas Medical Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- Lepping RJ, Montgomery RN, Sharma P, Mahnken JD, Vidoni ED, Choi IY, Sarnak MJ, Brooks WM, Burns JM, Gupta A. Normalization of Cerebral Blood Flow, Neurochemicals, and White Matter Integrity after Kidney Transplantation. J Am Soc Nephrol. 2021 Jan;32(1):177-187. doi: 10.1681/ASN.2020050584. Epub 2020 Oct 16.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2013
Primary Completion (Anticipated)
December 1, 2023
Study Completion (Anticipated)
December 1, 2023
Study Registration Dates
First Submitted
May 30, 2013
First Submitted That Met QC Criteria
June 20, 2013
First Posted (Estimate)
June 21, 2013
Study Record Updates
Last Update Posted (Actual)
February 9, 2021
Last Update Submitted That Met QC Criteria
February 4, 2021
Last Verified
February 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 13566
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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