IgA NephropathyNCT05190848
Correlation of Microbiome and Metabonomics With IgA Nephropathy
An observational study of IgA Nephropathy, run by Guangdong Provincial People's Hospital at 5 sites in China.
Trial summary
IgAN is the most prevalent primary glomerulonephritis in China, is characterized by the deposition of IgA1 (particularly, galactose-deficient IgA1) in the glomerular mesangium. Galactosedeficient IgA1, supposed to be produced by Peyer patches in the mucosa-associated lymphoid tissue (MALT), is triggered by exposure to… Read more about this study
- Who is it for?
- Ages 16 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- IgA Nephropathy
- How many people
- 600 participants
- Where
- 5 sitesChina
- Study dates
- 1 May 2020to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 16 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: IgA nephropathy confirmed by renal biopsy and family members living with them
Who may be able to join
- (1) Pathological changes of IgAN were confirmed by renal biopsy (2) Age ≥16 years (3) IgA deposition caused by secondary factors such as non-purpura glomerulonephritis, liver cirrhosis, SLE, HIV infection and hepatitis B virus associated nephritis (4) No antibiotics and/or functional foods (probiotics and/or prebiotics) for at least one month prior to sampling (5) No hormone or immunosuppressant treatment in the six months prior to sampling (6) No significant changes in diet or medication for at least one month (7) No other immune or autoimmune diseases, such as systemic lupus erythematosus (8) Signed informed consent
Who cannot join
- Type I or type II diabetes
- Pregnancy and menstrual period
- Mental illness and inability to assess follow-up
- Medically diagnosed intestinal diseases such as irritable bowel syndrome and inflammatory bowel disease
- Viral hepatitis or other infectious diseases
- One month before specimen collection, use laxatives including but not limited to polyethylene glycol electrolyte dispersant, enema and other laxatives
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
China5 sites, 5 recruiting
- Recruiting
Sun Yat-sen Memorial Hospital Sun Yat-sen university
Guangzhou, Guangdong
Qiongqiong Yang
- Recruiting
The Third Affiliated Hospital of Southern Medical University
Guangzhou, Guangdong
Ying Tang
- Recruiting
The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong
Hui Peng
- Recruiting
Guangdong Provincial People's Hospital
Guanzhou, Guangdong
Xueqing Yu, +86-20-83827812, yuxq@mail.sysu.edu.cn
Guangdong Provincial People's Hospital Cai, fengtaoc@126.com, fengtaoc@126.com
- Recruiting
The First Affiliated Hospital of Sun Yat-sen University
Guanzhou, Guangdong
Wei Chen
About this study
IgAN is the most prevalent primary glomerulonephritis in China, is characterized by the deposition of IgA1 (particularly, galactose-deficient IgA1) in the glomerular mesangium. Galactosedeficient IgA1, supposed to be produced by Peyer patches in the mucosa-associated lymphoid tissue (MALT), is triggered by exposure to commensal or pathogenic bacteria, involved in the initial step in the pathogenesis of IgAN. Similar to intestinal flora, a disruption in oral flora is closely associated with the occurrence of many malignant tumors and autoimmune diseases. The relationship between oral and throat microflora and the occurrence of IgAN is unclear at present. The aim of the present study was to develop a preliminary model based on mucosa -specific microbes and clinical indicators to facilitate the early diagnosis of IgAN and obtain insights into its treatment.
Read the detailed description
IgAN-microbiome is an investigator-initiated，multi-center，Observational study. This study will recruit IgA nephropathy patients who have not been treated with glucocorticoids and immunosuppressants for 6 months and have not taken antibiotics for 1 month and their family members. Feces, urine, blood, oral mucosal swabs, and pharyngeal swabs will be collected and tested for microflora and metabolites in these areas.
Similar samples from IgA nephropathy patients were collected after 2 months and 6 months, respectively, for bacterial community detection and metabolite detection, and the relationship between bacterial community change and metabolite change and disease progression was analyzed.
- Conditions
- IgA Nephropathy
- Keywords
- IgAN microbiome metabolite
- Medical subject headings
- Glomerulonephritis, IGA
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with all-cause death
Death for any reason.
Measured: From trial initiation to any event first occurrence,the first to arrive will be evaluated up to 6 months
Number of Participants with not meet the entry criteria
not meet the entry criteria for any reason
Measured: From trial initiation to any event first occurrence,the first to arrive will be evaluated up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2022
- Study start1 May 2020
- Primary completion1 Dec 2024
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IgA NephropathyStudies of the same condition, open and under way.
- More trials run by Guangdong Provincial People's HospitalThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, XueQing Yu, Guangdong Provincial People's Hospital
- Investigators
- Xueqing Yu, Study chair, Guangdong Provincial People's HospitalXinling Liang, Study director, Guangdong Provincial People's HospitalZhiming Ye, Study director, Guangdong Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05190848
- Sponsor's protocol ID
- GDPH-IgAN-microbiome
- Status last verified
- Sep 2026
- First submitted
- 27 Dec 2021
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of Microbiome and Metabonomics With IgA Nephropathy
- ClinicalTrials.gov ID
- NCT05190848
- Acronym / sponsor ID
- GDPH-IgAN-microbiome
- Conditions
- IgA Nephropathy
- Keywords
- IgAN microbiome metabolite
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Guangdong Provincial People's HospitalUniversity, hospital or other
- Study start
- 1 May 2020 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 13 Jan 2022 (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.
IgAN is the most prevalent primary glomerulonephritis in China, is characterized by the deposition of IgA1 (particularly, galactose-deficient IgA1) in the glomerular mesangium. Galactosedeficient IgA1, supposed to be produced by Peyer patches in the mucosa-associated lymphoid tissue (MALT), is triggered by exposure to commensal or pathogenic bacteria, involved in the initial step in the pathogenesis of IgAN. Similar to intestinal flora, a disruption in oral flora is closely associated with the occurrence of many malignant tumors and autoimmune diseases. The relationship between oral and throat microflora and the occurrence of IgAN is unclear at present. The aim of the present study was to develop a preliminary model based on mucosa -specific microbes and clinical indicators to facilitate the early diagnosis of IgAN and obtain insights into its treatment.
Detailed description
IgAN-microbiome is an investigator-initiated，multi-center，Observational study. This study will recruit IgA nephropathy patients who have not been treated with glucocorticoids and immunosuppressants for 6 months and have not taken antibiotics for 1 month and their family members. Feces, urine, blood, oral mucosal swabs, and pharyngeal swabs will be collected and tested for microflora and metabolites in these areas.
Similar samples from IgA nephropathy patients were collected after 2 months and 6 months, respectively, for bacterial community detection and metabolite detection, and the relationship between bacterial community change and metabolite change and disease progression was analyzed.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- IgA nephropathy confirmed by renal biopsy and family members living with them
Key inclusion criteria (1 listed)
- (1) Pathological changes of IgAN were confirmed by renal biopsy (2) Age ≥16 years (3) IgA deposition caused by secondary factors such as non-purpura glomerulonephritis, liver cirrhosis, SLE, HIV infection and hepatitis B virus associated nephritis (4) No antibiotics and/or functional foods (probiotics and/or prebiotics) for at least one month prior to sampling (5) No hormone or immunosuppressant treatment in the six months prior to sampling (6) No significant changes in diet or medication for at least one month (7) No other immune or autoimmune diseases, such as systemic lupus erythematosus (8) Signed informed consent
Key exclusion criteria (6 listed)
- Type I or type II diabetes
- Pregnancy and menstrual period
- Mental illness and inability to assess follow-up
- Medically diagnosed intestinal diseases such as irritable bowel syndrome and inflammatory bowel disease
- Viral hepatitis or other infectious diseases
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
Number of Participants with all-cause death
Time frame: From trial initiation to any event first occurrence,the first to arrive will be evaluated up to 6 months
Death for any reason.
Number of Participants with not meet the entry criteria
Time frame: From trial initiation to any event first occurrence,the first to arrive will be evaluated up to 6 months
not meet the entry criteria for any reason
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 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.
Xueqing Yu study chair
Guangdong Provincial People's Hospital
Xinling Liang study director
Guangdong Provincial People's Hospital
Zhiming Ye study director
Guangdong Provincial People's Hospital
5 sites 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, run by Guangdong Provincial People's Hospital at 5 sites 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 1 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xueqing Yu (+86-20-83827812, yuxq@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with all-cause death (time frame: From trial initiation to any event first occurrence,the first to arrive will be evaluated up to 6 months). The study lists 2 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 14 Sep 2026.