Cognitive Impairment and Imaging Correlates in End Stage Renal Disease

NCT ID: NCT01883349

Last Updated: 2024-10-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-03-31

Study Completion Date

2023-09-30

Brief Summary

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This is an observational cohort to understand cognitive impairment in end stage renal disease before and after a kidney transplant.

Detailed Description

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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.

Conditions

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End Stage Renal Disease

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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ESRD patients

ESRD patients awaiting renal transplantation

Kidney Transplant

Intervention Type PROCEDURE

Kidney Transplant Surgery

Control Arm

Subjects without kidney disease. No intervention with control group.

No kidney transplant

Intervention Type OTHER

The control group was made up of subjects without ESRD and were not on the renal transplantation waitlist.

Interventions

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Kidney Transplant

Kidney Transplant Surgery

Intervention Type PROCEDURE

No kidney transplant

The control group was made up of subjects without ESRD and were not on the renal transplantation waitlist.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Pre-transplant ESRD patients 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
Minimum Eligible Age

30 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Kansas Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Aditi Gupta, MD

Role: PRINCIPAL_INVESTIGATOR

University of Kansas Medical Center

Locations

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University of Kansas Medical Center

Kansas City, Kansas, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 33067382 (View on PubMed)

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.

Reference Type RESULT
PMID: 26894920 (View on PubMed)

Other Identifiers

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13566

Identifier Type: -

Identifier Source: org_study_id

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