Cognitive Impairment and Imaging Correlates in End Stage Renal Disease

NCT01883349 | Completed

• 1 other identifier: 13566
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

End Stage Renal Disease

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (7)

• Change in brain MRI

  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

• Change in verbal declarative/episodic memory

  Change from Baseline to 3 Months and 12 Months after Renal Transplant

• Change in delayed verbal declarative/episodic memory

  Change from Baseline to 3 Months and 12 Months after Renal Transplant

• Change in psychomotor speed and visuospatial function

  Change from Baseline to 3 Months and 12 Months after Renal Transplant

Study Arms (2)

ESRD patients

ESRD patients awaiting renal transplantation

Procedure: Kidney Transplant

Control Arm

Subjects without kidney disease. No intervention with control group.

Other: No kidney transplant

Interventions

Kidney Transplant PROCEDURE

Kidney Transplant Surgery

ESRD patients

No kidney transplant OTHER

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

Control Arm

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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 and 12 months after renal transplantation.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Kansas Medical Center: lead

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Related Publications (2)

• 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.

  PMID: 33067382 BACKGROUND

• 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.

  PMID: 26894920 RESULT

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Kidney Transplantation

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Renal Replacement Therapy; Therapeutics; Organ Transplantation; Transplantation; Surgical Procedures, Operative; Urologic Surgical Procedures; Urogenital Surgical Procedures

Study Officials

• Aditi Gupta, MD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2013
• First Posted: June 21, 2013
• Study Start: March 1, 2013
• Primary Completion: July 1, 2023
• Study Completion: September 1, 2023
• Last Updated: October 9, 2024

Record last verified: 2023-12

Locations

US (1)