Eye-Brain-Kidney in CKD

NCT07358572 | Recruiting

• 1 other identifier: EBK-CKD
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Kidney Diseases

Keywords

Multimodal magnetic resonance imaging; Montreal Cognitive Assessment

Outcome Measures

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.

  Baseline and 3-year follow-up.

Secondary Outcomes (18)

• Retinal Nerve Fiber Layer (RNFL) Thickness

  Baseline and 3-year follow-up.

• Average Macular Thickness

  Baseline and 3-year follow-up.

• Retinal Specific Lesion Count

  Baseline and 3-year follow-up.

• Retinal Capillary Plexus Vessel Density (VD)

  Baseline and 3-year follow-up.

• Retinal Non-Perfusion Area (NPA)

  Baseline and 3-year follow-up.

Eligibility Criteria

• Age: 18 Years - 70 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 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.

You may qualify if:

• 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.

You may not qualify if:

• Patients with recent or prior cerebral hemorrhage or cerebral infarction.
• History of epileptic seizures or psychiatric disorders.
• Patients with claustrophobia.
• Pregnant or lactating patients.
• Presence of other central nervous system diseases (e.g., tumor, trauma).
• Unstable angina, congestive heart failure (NYHA class III or IV), or acute myocardial infarction.
• Any systemic or other diseases deemed unsuitable for clinical trial participation.

Sponsors & Collaborators

• Beijing Friendship Hospital: lead

Study Sites (1)

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, 100050, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum and plasma samples obtained from the remaining blood after routine complete blood count and biochemistry tests. These samples will be stored in a biobank for centralized analysis of disease-related biomarkers, including but not limited to Tau, phosphorylated Tau, phenylacetylglutamine, indole acetic acid, and β2-microglobulin.

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Hao Wang

CONTACT

+86 18810643768; wanghao4756@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 26, 2025
• First Posted: January 22, 2026
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 31, 2031
• Study Completion (Estimated): December 31, 2031
• Last Updated: January 27, 2026

Record last verified: 2025-12

Locations

CN (1)