Exploring the Brain - Gut Microbiota - Kidney Interactive Damage Mechanisms Underlying Cognitive Decline in Patients With IgA Nephropathy Using Ultra-high Field Magnetic Resonance Imaging

NCT07617402 | Completed

• 1 other identifier: K202508-23
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

IgA nephropathy (IgAN) is the most common primary glomerular disease worldwide. Its progression is often accompanied by cognitive decline, manifesting as multi-dimensional cognitive deficits in areas such as memory, attention, and executive function. Cognitive decline in patients with IgAN severely impacts their quality of life, yet the underlying central nervous system (CNS) damage mechanisms remain unclear, and no effective interventions are currently available. Recent domestic and international studies suggest a potential interactive damage network involving the brain, gut microbiota, and kidneys in patients with chronic kidney disease (CKD). Therefore, exploring the causes of cognitive decline in IgAN patients from the perspective of multi-organ interactive damage, identifying brain injury targets and aberrant gut microbial communities that correlate with changes in renal function, is crucial for the development of effective and precise clinical interventions. Our team has been conducting MRI research on brain injury associated with cognitive decline in CKD since 2015. We have extensive experience in studying brain structure, function, metabolism, and perfusion in patients with end-stage renal disease (ESRD). Our work has been supported by numerous grants, including the General Program and Young Scientists Fund of the National Natural Science Foundation of China (NSFC) and the Key R\&D Program of Shaanxi Province, yielding a series of scientific achievements. The etiological heterogeneity and high prevalence of IgAN suggest that we should focus on the central mechanisms of cognitive decline in this specific patient population. The recent clinical application of 7.0 Tesla (T) ultra-high field MRI provides critical hardware support, enabling us to investigate sub-millimeter-level structural and functional abnormalities in the early stages of IgAN. This study aims to recruit 100 patients with IgAN from the Department of Nephrology and 100 demographically matched healthy controls from the local community. We will collect serum, stool samples, and brain ultra-high field MRI data from both patients and controls. By integrating these data with assessments from multi-dimensional neurocognitive scales, we will explore the potential brain-gut-kidney damage characteristics underlying cognitive decline in IgAN patients from the perspectives of serum metabolomics, fecal gut microbiota analysis, and multi-modal ultra-high field brain MRI analysis.

Conditions

IgA Nephropathy (IgAN)

Outcome Measures

Primary Outcomes (3)

• Gut Microbiome Metagenomic Characteristics

  Description: Taxonomic composition, relative abundance of microbial taxa, alpha diversity indices (Shannon, Simpson), and functional pathway profiles derived from shotgun metagenomic sequencing of fecal samples. Unit/Scale: Relative abundance (%), Shannon index, Simpson index, normalized pathway abundance.

  April 2025 to March 2027

• Functional Neuroimaging Indices

  Description: Resting-state functional magnetic resonance imaging (rs-fMRI) derived metrics, including functional connectivity (FC), amplitude of low-frequency fluctuation (ALFF), fractional ALFF (fALFF), and regional homogeneity (ReHo). Unit/Scale: Standardized Z-scores, correlation coefficients.

  April 2025 to March 2027

• Cognitive Function Scores

  Description: Cognitive performance assessed using the Montreal Cognitive Assessment (MoCA). Scale/Range: 0-30 points. Interpretation: Higher scores indicate better cognitive function; lower scores indicate more severe cognitive impairment.

  April 2025 to March 2027

Secondary Outcomes (4)

• Serum Metabolomic and Biomarker Levels

  April 2025 to March 2027

• Fecal Gut Microbiome Analysis

  April 2025 to March 2027

• Memory Function (Cognitive Subdomain)

  April 2025 to March 2027

• Attention and Executive Function (Cognitive Subdomains)

  April 2025 to March 2027

Study Arms (2)

IgAN

HC

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

IgA Nephropathy (IgAN) Group: A cohort of 100 patients diagnosed with IgA nephropathy, confirmed by pathological biopsy. Healthy Control (HC) Group: A cohort of 100 healthy volunteers who are demographically matched to the patient group in terms of age, gender, and educational attainment.

You may qualify if:

• Right-handed individuals, age 18-60 years;
• Diagnosis of IgA nephropathy confirmed by renal biopsy.

You may not qualify if:

• Secondary IgA nephropathy, such as that associated with systemic lupus erythematosus, rheumatoid arthritis, Sjögren's syndrome, hepatitis B or C infection, or drug-induced causes.
• History of kidney transplantation, hemodialysis, or peritoneal dialysis.
• Acute cerebrovascular event within the past 3 months; a history of severe traumatic brain injury, brain tumor, stroke, or encephalomalacia that has resulted in identifiable lesions or significant asymmetry of cranial anatomy.
• Malignant tumors; a history of intestinal surgery; or irritable bowel syndrome (IBS).
• Use of antibiotics, steroids, immunosuppressants, or microbiota-based preparations within the past month.
• Inflammatory bowel disease (IBD); or the presence of symptoms such as diarrhea, abdominal pain, or IBS-like symptoms within the past two weeks.
• History of alcohol dependence.
• Current use of psychiatric medications, such as antidepressants or anxiolytics.
• Loss of hearing or vision.
• Pregnancy or lactation.
• Current participation in another clinical trial.
• Contraindications for 7.0T MRI Presence of ferromagnetic implants in the body (e.g., cardiac pacemakers, defibrillators, neurostimulators, aneurysm clips, cochlear implants, or any other metallic foreign bodies).
• Non-ferromagnetic implants (e.g., titanium alloy, orthopedic implants), intrauterine devices (IUDs), or non-removable dental prosthetics (including dental implants).
• Metallic foreign bodies in the eye or body (e.g., metal fragments, shrapnel, or metallic debris), such as in individuals with a history of welding or metal-related injuries.
• Tattoos or permanent makeup (e.g., on eyebrows or lips) acquired within the last month.

Sponsors & Collaborators

• Tang-Du Hospital: lead

Study Sites (1)

Functional and Molecular Imaging Key Lab of Shaanxi Province, Department of Radiology, Tangdu Hospital, Fourth Military Medical University

Shanxi, Xi'an, 713800, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Stool/Fecal samples

MeSH Terms

Conditions

Glomerulonephritis, IGA

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2026
• First Posted: June 1, 2026
• Study Start: April 1, 2025
• Primary Completion: May 5, 2026
• Study Completion: May 5, 2026
• Last Updated: June 1, 2026

Record last verified: 2026-05

Locations

CN (1)