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This is an observational cohort to understand cognitive impairment in end stage renal disease before and after a kidney transplant.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ESRD patients | ESRD patients awaiting renal transplantation |
| |
| Control Arm | Subjects without kidney disease. No intervention with control group. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Kidney Transplant | Procedure | Kidney Transplant Surgery |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Cognitive Function | Cognition will be assessed using relevant neuropsychological tests used by National Alzheimers Coordination center (NACC) uniform data set (UDS). Primary outcome will be logical memory. Score range 0-25. Higher scores indicate better cognitive function. | Change from Baseline to 3 Months and 12 Months after Renal Transplant |
| Measure | Description | Time Frame |
|---|---|---|
| Change in brain MRI | Brain MRI will be performed before and after transplant | Change from Baseline to 3 Months and 12 months after Renal Transplant |
| Change in inflammatory markers | Change from Baseline to 3 months and 12 months post transplant |
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Inclusion Criteria:
Exclusion Criteria:
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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 and 12 months after renal transplantation.
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| Name | Affiliation | Role |
|---|---|---|
| Aditi Gupta, MD | University of Kansas Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33067382 | Background | 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. | |
| 26894920 | Result |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| ID | Term |
|---|---|
| D016030 | Kidney Transplantation |
| ID | Term |
|---|---|
| D017582 | Renal Replacement Therapy |
| D013812 | Therapeutics |
| D016377 | Organ Transplantation |
| D014180 | Transplantation |
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| No kidney transplant |
| Other |
The control group was made up of subjects without ESRD and were not on the renal transplantation waitlist. |
|
| Change in verbal declarative/episodic memory | WMS-R Logical Memory I- Immediate is a test where a brief story is read to subject, who is then asked to retell it from memory immediately; primary measure of performance is number of story units recalled. Scores are from 0-25 with higher scores indicating better cognition. | Change from Baseline to 3 Months and 12 Months after Renal Transplant |
| Change in delayed verbal declarative/episodic memory | WMS-R Logical Memory II- Delayed measures delayed recall of story read to the participant at the beginning of testing session (WMS-R Logical Memory I- Immediate). Scores range from 0-25 with higher scores indicating better cognition. | Change from Baseline to 3 Months and 12 Months after Renal Transplant |
| Change in psychomotor speed and visuospatial function | WAIS-R Digit Symbol Substitution test is where a subject is given a key consisting of numbers 1-9, each paired with a unique, easy-to-draw symbol; subject fills in corresponding symbol for each number in a limited time. Scores are from 0-133 with higher scores indicating better cognition. | Change from Baseline to 3 Months and 12 Months after Renal Transplant |
| Change in general dementia screening score | Mini-Mental State Examination Screening scale evaluates orientation to place, orientation to time, registration, attention and concentration, recall, language, and visual construction. Scores range from 0-30 with higher scores indicate better cognition. | Change from Baseline to 3 Months and 12 Months after Renal Transplant |
| Change in working memory or attention | Digit Span forward and backward are tests where a subject is read sequences of increasing length and asked to repeat them. Digit span length is the length of the highest digit sequence the subject is able to repeat correctly. Scores range from 0-12 with higher scores indicate better cognition. | Change from Baseline to 3 Months and 12 Months after Renal Transplant |
| 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. |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013514 |
| Surgical Procedures, Operative |
| D013520 | Urologic Surgical Procedures |
| D013519 | Urogenital Surgical Procedures |