Eye-Brain-Kidney in CKD
ConditionChronic Kidney Diseases
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-70
SponsorBeijing Friendship Hospital
About this trial
The goal of this observational study is to learn about the interaction between the eyes, brain, and kidneys in adult patients with Chronic Kidney Disease (CKD). The main question it aims to answer is:
Do changes in the brain's network connectivity and the retina's blood vessels correlate with cognitive decline and kidney function in CKD patients? Participants with CKD who are already undergoing clinical care will complete cognitive tests and questionnaires, have non-invasive MRI scans of their brain and kidneys, and undergo non-invasive eye imaging (OCT/OCTA) of their retinas.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged 18-70 years.
Patients clinically diagnosed with CKD stages 1-5.
No contraindications for MRI examination (e.g., cardiac pacemaker, claustrophobia, cochlear implant, hearing aid, coronary stents implanted before 2015) and able to complete the MRI scan.
Disqualifiers
Patients with recent or prior cerebral hemorrhage or cerebral infarction.
History of epileptic seizures or psychiatric disorders.
Patients with claustrophobia.
Pregnant or lactating patients.
Trial population
The study population will consist of a prospective cohort of adult patients with Chronic Kidney Disease (CKD) recruited from a single clinical center. All participants will be selected from patients attending the Department of Nephrology and other relevant clinics at Beijing Friendship Hospital, Capital Medical University. The primary eligibility criteria include an age range of 18 to 70 years and a clinical diagnosis of CKD at any stage (1 through 5). Key exclusions are applied to ensure patient safety and specificity of the observational findings, primarily concerning conditions that contraindicate MRI procedures or represent significant, unstable comorbid systemic, cardiovascular, or neuropsychiatric diseases. A total of 1500 participants meeting these criteria are planned to be enrolled. Each participant will undergo a comprehensive baseline assessment and a follow-up evaluation at 3 years.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Cognitive function assessed by Montreal Cognitive Assessment (MoCA)
The Montreal Cognitive Assessment (MoCA) is a cognitive screening tool with a total score range of 0 to 30, where higher scores indicate better cognitive function. A score below 26 is indicative of cognitive impairment.
Time frame
Baseline and 3-year follow-up.Secondary outcomes
1
Retinal Nerve Fiber Layer (RNFL) Thickness
Thickness of the retinal nerve fiber layer, measured in micrometers (μm) using optical coherence tomography (OCT).
Time frame
Baseline and 3-year follow-up.2
Average Macular Thickness
The average thickness of the macular region, measured in micrometers (μm) via optical coherence tomography (OCT).
Time frame
Baseline and 3-year follow-up.3
Retinal Specific Lesion Count
The number of specific lesions (e.g., microaneurysms, hemorrhages) identified in the retina, reported as a count.
Time frame
Baseline and 3-year follow-up.4
Retinal Capillary Plexus Vessel Density (VD)
The density of blood flow in the retinal capillary networks, expressed as a percentage (%) measured by optical coherence tomography angiography (OCTA).
Time frame
Baseline and 3-year follow-up.Sponsors and contacts
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Source ClinicalTrials.gov