NCT07617402Completed

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

Brain-Gut-Kidney Axis in IgA Nephropathy Cognitive Decline: An Ultra-High Field MRI Study

Source: ClinicalTrials.gov · Last updated 1 Jun 2026

Brief summary (registry, in English)

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.

Status (registry): Completed
Study type: Observational
Enrollment: 200 (actual)
First submitted: 12 May 2026
Start date: 1 Apr 2025
Primary completion date: 5 May 2026
Lead sponsor: Tang-Du Hospital
Diseases: IgA nephropathy
NCT number: NCT07617402

What you commit to

Study type: Observational
Participants enrolled: 200
From 1 Apr 2025 to the primary completion date, 5 May 2026
1 site in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

Use of antibiotics, steroids, immunosuppressants, or microbiota-based preparations within the past month.

Other illness

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).
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.
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.
- Claustrophobia. Fever. Inclusion Criteria for the Healthy Control Group
- All healthy controls must meet the following criteria:
All physiological indicators within the normal range, with no signs of disease;
No family history of psychiatric or neurological disorders.
History of cranial surgery, brain tumor, traumatic brain injury, stroke, or encephalomalacia resulting in significant asymmetry of cranial anatomy;
History of psychiatric disorders, alcohol dependence, or central nervous system diseases;
History of hypertension, diabetes, or hyperlipidemia;
Hearing or vision impairment that would affect communication during the MRI scan or the completion of cognitive assessments.

Age

Right-handed, aged 18-60 years;

Other

Loss of hearing or vision.
Pregnancy or lactation.
Presence of metallic foreign bodies in the body or claustrophobia, making them unsuitable for MRI scanning;

Who the study is looking for

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

Age in the registry: 18 years to 60 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
Functional and Molecular Imaging Key Lab of Shaanxi Province, Department of Radiology, Tangdu Hospital, Fourth Military Medical University Coordinator of this site? Confirm its status	Shanxi	China	Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.