IgA Nephropathy (IgAN)NCT07617402
Exploring the Brain - Gut Microbiota - Kidney Interactive Damage Mechanisms Underlying Cognitive Decline in Patients With IgA Nephropathy Using Ultra-high Field Magnetic Resonance Imaging
An observational study of IgA Nephropathy (IgAN), run by Tang-Du Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- IgA Nephropathy (IgAN)
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2025to 5 May 2026
- How long will I take part?
- 12 Months
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- Right-handed individuals, age 18-60 years;
- Diagnosis of IgA nephropathy confirmed by renal biopsy.
Who cannot join
- 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.
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- 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.
- Claustrophobia. Fever. Inclusion Criteria for the Healthy Control Group
- All healthy controls must meet the following criteria:
- Right-handed, aged 18-60 years;
- 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;
- Presence of metallic foreign bodies in the body or claustrophobia, making them unsuitable for MRI scanning;
- History of hypertension, diabetes, or hyperlipidemia;
- Hearing or vision impairment that would affect communication during the MRI scan or the completion of cognitive assessments.
Trial locations and contacts
1 site in 1 country.
China1 site
Functional and Molecular Imaging Key Lab of Shaanxi Province, Department of Radiology, Tangdu Hospital, Fourth Military Medical University
Shanxi, Xi'an, 713800
About this study
Official title: Brain-Gut-Kidney Axis in IgA Nephropathy Cognitive Decline: An Ultra-High Field MRI Study
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)
- Medical subject headings
- Glomerulonephritis, IGA
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 |
|---|---|---|
| IgAN | Not described | |
| HC | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: April 2025 to March 2027
Secondary outcomes (4)
Serum Metabolomic and Biomarker Levels
Description: Quantitative analysis of serum metabolomic profiles, inflammatory factors (e.g., IL-6, TNF-α), and neurotransmitters (e.g., serotonin, dopamine) using targeted metabolomics assays.
Unit/Scale: pg/mL, ng/mL, or standardized relative concentration units.
Measured: April 2025 to March 2027
Fecal Gut Microbiome Analysis
Description: Taxonomic composition, alpha/beta diversity, and differential microbial taxa identified via 16S rRNA gene sequencing or shotgun metagenomic sequencing of fecal samples.
Unit/Scale: Relative abundance (%), Shannon index, Simpson index, Bray-Curtis dissimilarity.
Measured: April 2025 to March 2027
Memory Function (Cognitive Subdomain)
Description: Verbal memory assessed using the Auditory Verbal Learning Test (AVLT).
Scale/Range: 0-75 points (AVLT total recall score). Interpretation: Higher scores indicate better memory performance.
Measured: April 2025 to March 2027
Attention and Executive Function (Cognitive Subdomains)
Description: Attention and executive function assessed using the Stroop Color-Word Test and Trail Making Test (TMT).
Unit/Scale: Reaction time (seconds), completion time (seconds), number of errors.
Interpretation: Shorter completion time and fewer errors indicate better attention and executive function.
Measured: April 2025 to March 2027
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2026
- Study start1 Apr 2025
- Primary completion5 May 2026
- Study completion5 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IgA Nephropathy (IgAN)Studies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Tang-Du Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07617402
- Sponsor's protocol ID
- K202508-23
- Status last verified
- May 2026
- First submitted
- 12 May 2026
- Last updated
- 1 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain-Gut-Kidney Axis in IgA Nephropathy Cognitive Decline: An Ultra-High Field MRI Study
- ClinicalTrials.gov ID
- NCT07617402
- Acronym / sponsor ID
- K202508-23
- Conditions
- IgA Nephropathy (IgAN)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Tang-Du HospitalUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 5 May 2026 (actual)
- Study completion
- 5 May 2026 (actual)
- First posted
- 1 Jun 2026 (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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IgAN | – | – |
| HC | – | – |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (2 listed)
- Right-handed individuals, age 18-60 years;
- Diagnosis of IgA nephropathy confirmed by renal biopsy.
Key exclusion criteria (25 listed)
- 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.
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
Gut Microbiome Metagenomic Characteristics
Time frame: April 2025 to March 2027
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.
Functional Neuroimaging Indices
Time frame: April 2025 to March 2027
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.
Cognitive Function Scores
Time frame: April 2025 to March 2027
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.
4 secondary outcomes
Serum Metabolomic and Biomarker Levels
Time frame: April 2025 to March 2027
Fecal Gut Microbiome Analysis
Time frame: April 2025 to March 2027
Memory Function (Cognitive Subdomain)
Time frame: April 2025 to March 2027
Attention and Executive Function (Cognitive Subdomains)
Time frame: April 2025 to March 2027
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of IgA Nephropathy (IgAN), run by Tang-Du Hospital at 1 site 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 2 inclusion and 25 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: finished, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gut Microbiome Metagenomic Characteristics (time frame: April 2025 to March 2027). The study lists 3 primary outcomes in all. 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 1 Jun 2026; AzTrials last refreshed its copy on 28 Oct 2026.