End-stage Kidney DiseaseNCT03191409
Interaction Research on Cognitive Impairment and Emotional Disorder in End-stage Renal Disease
An observational study of End-stage Kidney Disease and Brain Damage, run by First Affiliated Hospital Xi'an Jiaotong University at 2 sites in China.
Trial summary
End stage renal disease (ESRD) is the last stage (stage 5) of chronic kidney disease (CKD). Abnormalities of cognitive function and high levels of depression or anxiety incidence are characteristic of hemodialysis patients. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- End-stage Kidney Disease, Brain Damage
- How many people
- 50 participants
- Where
- 2 sitesChina
- Study dates
- 15 Jun 2017to 30 Jun 2019
- 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: ESRD patients before dialysis initiation
Who may be able to join
- Age 18-50 years;
- ESRD patients who will start hemodialysis
- High quality MRI scan;
- dextromanual
Who cannot join
- Diabetes,Brain tumor,brain trauma
- Neuropsychiatric disease
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710061
Ming Zhang, Ph.D, 18991232265, zmmri@163.com
- Recruiting
First affiliated hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710061
Ming Zhang, Ph.D, 18991232265, zmmri@163.com
Dun Ding, MD
About this study
End stage renal disease (ESRD) is the last stage (stage 5) of chronic kidney disease (CKD). Abnormalities of cognitive function and high levels of depression or anxiety incidence are characteristic of hemodialysis patients. In this research project, the investigators subject in ESRD patients starting hemodialysis as the carrier. Based on the longitudinal research design, using multimodal neuroimaging data，combining with the interact relationship between changes of brain morphology, the dysfunction of resting-state and-task state with cognitive impairment and abnormal emotions.Establish brain structure-function change model associated with dialysis progression, Explore imaging markers of central and disease development characteristics in ESRD patients. the investigators attempt to clarify the core mechanism of kidney-brain axis damage, thus provide evidence for early cognitive-behavioral therapy to CKD patient.
- Conditions
- End-stage Kidney Disease, Brain Damage
- Keywords
- cognitive impairment, ESRD, functional MRI
- Medical subject headings
- Kidney Failure, Chronic, Brain Injuries, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Health adults with no evidence of brain lesions on conventional magnetic resonance imaging(MRI) and no neural developmental disorders. | |
| Patients Group | ESRD patients pre-hemodialysis will be collected.The following exclusion criteria were applied in this study: (a)history of drug or alcohol abuse, (b) brain lesions such as a tumor or stroke assessed on the basis of medical history, (c) history of or current psychiatric disorders, and (d) head motion more than 1.0 mm or 1.0°during magnetic resonance imaging. All patients completed laboratory tests to evaluate renal function,serum creatinine, and urea levels within the 12 hours before magnetic resonance imaging. |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in cognitive function
Cognitive testing will be performed for assessment
Measured: Change from Baseline to 3 Months after dialysis
Secondary outcomes (1)
Change in brain MRI
Brain MRI will be performed before dialysis initiation and dialysis more than 3 months
Measured: Change from Baseline to 3 Months after dialysis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2017
- Study start15 Jun 2017
- Primary completion15 Jun 2019 (estimated)
- Study completion30 Jun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End-stage Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital Xi'an Jiaotong UniversityThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Xidian University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03191409
- Sponsor's protocol ID
- 2015YK15
- Status last verified
- Jul 2017
- First submitted
- 22 Jun 2016
- Last updated
- 14 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interaction Research on Cognitive Impairment and Emotional Disorder in End-stage Renal Disease
- ClinicalTrials.gov ID
- NCT03191409
- Acronym / sponsor ID
- 2015YK15
- Conditions
- End-stage Kidney Disease, Brain Damage
- Keywords
- cognitive impairment, ESRD, functional MRI
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Collaborators
- Xidian University
- Study start
- 15 Jun 2017 (actual)
- Primary completion
- 15 Jun 2019 (estimated)
- Study completion
- 30 Jun 2019 (estimated)
- First posted
- 19 Jun 2017 (actual)
- 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.
End stage renal disease (ESRD) is the last stage (stage 5) of chronic kidney disease (CKD). Abnormalities of cognitive function and high levels of depression or anxiety incidence are characteristic of hemodialysis patients. In this research project, the investigators subject in ESRD patients starting hemodialysis as the carrier. Based on the longitudinal research design, using multimodal neuroimaging data，combining with the interact relationship between changes of brain morphology, the dysfunction of resting-state and-task state with cognitive impairment and abnormal emotions.Establish brain structure-function change model associated with dialysis progression, Explore imaging markers of central and disease development characteristics in ESRD patients. the investigators attempt to clarify the core mechanism of kidney-brain axis damage, thus provide evidence for early cognitive-behavioral therapy to CKD patient.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | – | –Health adults with no evidence of brain lesions on conventional magnetic resonance imaging(MRI) and no neural developmental disorders. |
| Patients Group | – | –ESRD patients pre-hemodialysis will be collected.The following exclusion criteria were applied in this study: (a)history of drug or alcohol abuse, (b) brain lesions such as a tumor or stroke assessed on the basis of medical history, (c) history of or current psychiatric disorders, and (d) head motion more than 1.0 mm or 1.0°during magnetic resonance imaging. All patients completed laboratory tests to evaluate renal function,serum creatinine, and urea levels within the 12 hours before magnetic resonance imaging. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- ESRD patients before dialysis initiation
Key inclusion criteria (4 listed)
- Age 18-50 years;
- ESRD patients who will start hemodialysis
- High quality MRI scan;
- dextromanual
Key exclusion criteria (2 listed)
- Diabetes,Brain tumor,brain trauma
- Neuropsychiatric disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
change in cognitive function
Time frame: Change from Baseline to 3 Months after dialysis
Cognitive testing will be performed for assessment
1 secondary outcome
Change in brain MRI
Time frame: Change from Baseline to 3 Months after dialysis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2017.
- Individual participant dataSharing planned: Undecided
Related trials for End-stage Kidney Disease
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Recruiting
Guiding Optimal Blood Pressure Management in Peritoneal Dialysis Pilot Trial
End Stage Kidney Disease (ESKD), Hypertension (HTN)
RecruitingObservational study
Physical Impairments in Children With Chronic Renal Failure
Chronic Kidney Failure, Chronic Kidney Diseases
RecruitingPhase 1
A Study to Test the Safety of the Study Drug Fosmanogepix and How the Body Handles It in Adults With Severe Kidney Failure on Dialysis
End Stage Renal Disease on Dialysis, Adult
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.
2 sites 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 Kidney Disease and Brain Damage, run by First Affiliated Hospital Xi'an Jiaotong University at 2 sites in China.
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 4 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 14 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ming Zhang, Ph.D (18991232265, zmmri@163.com), or a site near the patient. 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 after dialysis). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Jul 2017.