End Stage Renal DiseaseNCT01883349
Cognitive Impairment and Imaging Correlates in End Stage Renal Disease
An observational study of End Stage Renal Disease, run by University of Kansas Medical Center at 1 site in United States.
Trial summary
This is an observational cohort to understand cognitive impairment in end stage renal disease before and after a kidney transplant. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- End Stage Renal Disease
- What is being tested?
- Kidney Transplant and No kidney transplant
- Type of treatment
- Surgery or procedure
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2013to Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
This is an observational cohort to understand cognitive impairment in end stage renal disease before and after a kidney transplant.
Read the 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.
- Conditions
- End Stage Renal Disease
- Being tested
- Kidney Transplant, No kidney transplant
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kidney TransplantProcedure or surgery
Kidney Transplant Surgery
No kidney transplantOther
The control group was made up of subjects without ESRD and were not on the renal transplantation waitlist.
| Study group | Role | What they receive |
|---|---|---|
| ESRD patients | ESRD patients awaiting renal transplantation Receives: Procedure: Kidney Transplant | |
| Control Arm | Subjects without kidney disease. No intervention with control group. Receives: Other: No kidney transplant |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from Baseline to 3 Months and 12 Months after Renal Transplant
Secondary outcomes (7)
Change in brain MRI
Brain MRI will be performed before and after transplant
Measured: Change from Baseline to 3 Months and 12 months after Renal Transplant
Change in inflammatory markers
Measured: Change from Baseline to 3 months and 12 months post transplant
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change from Baseline to 3 Months and 12 Months after Renal Transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2013 (estimated)
- Study startMar 2013
- Primary completionJul 2023
- Study completionSep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aditi Gupta, MD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01883349
- Sponsor's protocol ID
- 13566
- Status last verified
- Dec 2023
- First submitted
- 30 May 2013
- Last updated
- 9 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 33067382Gupta 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.
PubMed 26894920
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Impairment and Imaging Correlates in End Stage Renal Disease
- ClinicalTrials.gov ID
- NCT01883349
- Acronym / sponsor ID
- 13566
- Conditions
- End Stage Renal Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Jul 2023 (actual)
- Study completion
- Sep 2023 (actual)
- First posted
- 21 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an observational cohort to understand cognitive impairment in end stage renal disease before and after a kidney transplant.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ESRD patients | – | Procedure: Kidney TransplantESRD patients awaiting renal transplantation |
| Control Arm | – | Other: No kidney transplantSubjects without kidney disease. No intervention with control group. |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kidney TransplantKidney Transplant Surgery | Procedure or surgery | ESRD patients |
| No kidney transplantThe control group was made up of subjects without ESRD and were not on the renal transplantation waitlist. | Other | Control Arm |
Primary outcome
Change in Cognitive Function
Time frame: Change from Baseline to 3 Months and 12 Months after Renal Transplant
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.
7 secondary outcomes
Change in brain MRI
Time frame: Change from Baseline to 3 Months and 12 months after Renal Transplant
Change in inflammatory markers
Time frame: Change from Baseline to 3 months and 12 months post transplant
Change in verbal declarative/episodic memory
Time frame: Change from Baseline to 3 Months and 12 Months after Renal Transplant
Change in delayed verbal declarative/episodic memory
Time frame: Change from Baseline to 3 Months and 12 Months after Renal Transplant
Change in psychomotor speed and visuospatial function
Time frame: Change from Baseline to 3 Months and 12 Months after Renal Transplant
Change in general dementia screening score
Time frame: Change from Baseline to 3 Months and 12 Months after Renal Transplant
Change in working memory or attention
Time frame: Change from Baseline to 3 Months and 12 Months after Renal Transplant
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2024.
- Background: PubMed 33067382Lepping 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.
- Results publication: PubMed 26894920Gupta 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aditi Gupta, MD principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of End Stage Renal Disease, run by University of Kansas Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Cognitive Function (time frame: Change from Baseline to 3 Months and 12 Months after Renal Transplant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01883349, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2024; AzTrials last refreshed its copy on 7 Nov 2026.