IgA NephropathyNCT04858724
The Chinese Registry of Prognostic Study of IgA Nephropathy (CRPIGA)
An observational study of IgA Nephropathy, run by Ruijin Hospital at 1 site in China.
Trial summary
1. Establish an IgAN cohort collaboration group and expert committee to carry out registration research. 2. Construct IgAN structured data set standards, formulate structured data collection templates of diagnosis and treatment , and establish multi-center data integration systems on this basis. 3. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- IgA Nephropathy
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2020to 30 Dec 2027
- How long will I take part?
- 12 Months
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Biopsy-proven primary IgAN patients
Who may be able to join
- No age limit, no gender limit;
- Kidney biopsy confirmed primary IgA nephropathy;
- Sign the informed consent form voluntarily
Who cannot join
- IgA nephropathy is secondary to systemic diseases such as systemic lupus erythematosus and allergic purpura;
- IgAN is clinically diagnosed but not confirmed by pathology;
- The patient refuses to participate;
- Patients judged by other investigators to be unsuitable for inclusion in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Ruijin Hospital, Shanghai JiaoTong University School of Medicine
Shanghai, Shanghai Municipality, 200025
Jingyuan Xie, 13761056656 ext. +86, nephroxie@163.com
About this study
Official title: Construction of a Multi-center Database for Primary IgA Nephropathy
- Establish an IgAN cohort collaboration group and expert committee to carry out registration research.
- Construct IgAN structured data set standards, formulate structured data collection templates of diagnosis and treatment , and establish multi-center data integration systems on this basis.
- Establish a standardized IgAN database for combined Hospital Information System and the big data platform of the Medical Federation.
- Develop IgAN database managements and open standards for data sharing, and carry out high-quality clinical or basic research.
Read the detailed description
Primary IgA nephropathy (IgAN) is the most common form of glomerulonephritis in China and the world. It is the main reason for Chinese young people's renal failure. The main difficulties in clinical IgAN and treatment are 1) high clinical and prognostic heterogeneity, the prognosis cannot be accurately predicted; 2) no clinically available biomarkers, diagnosis is established by kidney biopsy; 3) The lack of specific treatment methods. These lead 20-40% of IgAN patients to develop end-stage renal failure (ESRD) after 10 to 20 years. Therefore, to improve clinical diagnosis, treatment, and scientific research of IgAN, it is much-needed to establish high-quality long-term cohort study, multi-center database, biobank, and conduct high-quality clinical research.
The incidence of IgAN in the Asia Pacific region is higher than in other regions, and China is one of the countries with the highest incidence of IgAN in the world. Although the number of IgAN patients in our country is vast and the clinical data and patient sample resources are abundant, the clinical diagnosis and treatment are not standardized, the follow-up rate is low, and the quality of clinical data is poor, which seriously affect the development of related clinical research. Therefore, optimization and integration of health care big data under careful top-level design is urgently needed.
Regarding IgAN, the Nephrology Department of Ruijin Hospital has been active in clinical database construction and clinical biobank management and has carried out several clinical and basic research. The world's largest IgAN cohort-CRPIGA cohort has been established, all patients in the cohort are followed up in a standardized manner by special personnel, and the data is recorded in a clinical database in real-time. However, optimization and integration of health care big data under careful top-level design is urgently needed. It is to establish IgAN specific disease structured data set standard in a multi-center linkage mode, formulate IgAN diagnosis and treatment specifications and clinical pathway standards, develop structured clinical case diagnosis and treatment information collection template, real-time scrape the actual clinical IgAN diagnosis and treatment data of various hospitals through the big data platform of health care consortium, clean and structure the acquired data, establish a multi-center structured database, integrate resources, strengthen advantages, and provide a qualified database for clinical research in the real world. All diagnosis and treatment data for the same patient are linked and integrated to offer individual patient-based longitudinal tracking records and support evidence-based medicine.
This study aims to improve the scale and quality of the IgAN multi-center cohort database, advance the clinical and basic research of IgAN, standardize and optimize the clinical diagnosis and treatment path of IgAN, provide more effective and safe treatment options for more IgAN patients and also provide evidence-based medicine evidence support.
- Conditions
- IgA Nephropathy
- Keywords
- IgAN, database, multicenter
- Medical subject headings
- Glomerulonephritis, IGA
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of a decline in estimated glomerular filtration rate by > 50% from baseline
To evaluate the renal function
Measured: 1 year
The proportion of doubling serum creatinine compared with baseline
To evaluate the renal function
Measured: 1 year
Incidence of ESRD
To evaluate the renal function
Measured: 1 year
Secondary outcomes (2)
Incidence of cardiovascular events
Record of Cardiovascular events during follow-up period
Measured: 1 year
Incidence of All-cause death
Record of All-cause death during follow-up period
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2021
- Study start1 Dec 2020
- Primary completion30 Dec 2027 (estimated)
- Study completion30 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 Ruijin 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- RenJi Hospital, Huashan Hospital, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
- Responsible party
- Sponsor
- Investigators
- Jingyuan Xie, Principal investigator, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04858724
- Sponsor's protocol ID
- CRPIGA
- Status last verified
- Aug 2026
- First submitted
- 19 Apr 2021
- Last updated
- 18 Aug 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 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Construction of a Multi-center Database for Primary IgA Nephropathy
- ClinicalTrials.gov ID
- NCT04858724
- Acronym / sponsor ID
- CRPIGA
- Conditions
- IgA Nephropathy
- Keywords
- IgAN, database, multicenter
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Collaborators
- RenJi Hospital, Huashan Hospital, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 26 Apr 2021 (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.
- Establish an IgAN cohort collaboration group and expert committee to carry out registration research.
- Construct IgAN structured data set standards, formulate structured data collection templates of diagnosis and treatment , and establish multi-center data integration systems on this basis.
- Establish a standardized IgAN database for combined Hospital Information System and the big data platform of the Medical Federation.
- Develop IgAN database managements and open standards for data sharing, and carry out high-quality clinical or basic research.
Detailed description
Primary IgA nephropathy (IgAN) is the most common form of glomerulonephritis in China and the world. It is the main reason for Chinese young people's renal failure. The main difficulties in clinical IgAN and treatment are 1) high clinical and prognostic heterogeneity, the prognosis cannot be accurately predicted; 2) no clinically available biomarkers, diagnosis is established by kidney biopsy; 3) The lack of specific treatment methods. These lead 20-40% of IgAN patients to develop end-stage renal failure (ESRD) after 10 to 20 years. Therefore, to improve clinical diagnosis, treatment, and scientific research of IgAN, it is much-needed to establish high-quality long-term cohort study, multi-center database, biobank, and conduct high-quality clinical research.
The incidence of IgAN in the Asia Pacific region is higher than in other regions, and China is one of the countries with the highest incidence of IgAN in the world. Although the number of IgAN patients in our country is vast and the clinical data and patient sample resources are abundant, the clinical diagnosis and treatment are not standardized, the follow-up rate is low, and the quality of clinical data is poor, which seriously affect the development of related clinical research. Therefore, optimization and integration of health care big data under careful top-level design is urgently needed.
Regarding IgAN, the Nephrology Department of Ruijin Hospital has been active in clinical database construction and clinical biobank management and has carried out several clinical and basic research. The world's largest IgAN cohort-CRPIGA cohort has been established, all patients in the cohort are followed up in a standardized manner by special personnel, and the data is recorded in a clinical database in real-time. However, optimization and integration of health care big data under careful top-level design is urgently needed. It is to establish IgAN specific disease structured data set standard in a multi-center linkage mode, formulate IgAN diagnosis and treatment specifications and clinical pathway standards, develop structured clinical case diagnosis and treatment information collection template, real-time scrape the actual clinical IgAN diagnosis and treatment data of various hospitals through the big data platform of health care consortium, clean and structure the acquired data, establish a multi-center structured database, integrate resources, strengthen advantages, and provide a qualified database for clinical research in the real world. All diagnosis and treatment data for the same patient are linked and integrated to offer individual patient-based longitudinal tracking records and support evidence-based medicine.
This study aims to improve the scale and quality of the IgAN multi-center cohort database, advance the clinical and basic research of IgAN, standardize and optimize the clinical diagnosis and treatment path of IgAN, provide more effective and safe treatment options for more IgAN patients and also provide evidence-based medicine evidence support.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Biopsy-proven primary IgAN patients
Key inclusion criteria (3 listed)
- No age limit, no gender limit;
- Kidney biopsy confirmed primary IgA nephropathy;
- Sign the informed consent form voluntarily
Key exclusion criteria (4 listed)
- IgA nephropathy is secondary to systemic diseases such as systemic lupus erythematosus and allergic purpura;
- IgAN is clinically diagnosed but not confirmed by pathology;
- The patient refuses to participate;
- Patients judged by other investigators to be unsuitable for inclusion in the study.
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
The proportion of a decline in estimated glomerular filtration rate by > 50% from baseline
Time frame: 1 year
To evaluate the renal function
The proportion of doubling serum creatinine compared with baseline
Time frame: 1 year
To evaluate the renal function
Incidence of ESRD
Time frame: 1 year
To evaluate the renal function
2 secondary outcomes
Incidence of cardiovascular events
Time frame: 1 year
Incidence of All-cause death
Time frame: 1 year
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 18 Aug 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.
Jingyuan Xie principal investigator
Ruijin Hospital
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, run by Ruijin 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 3 inclusion and 4 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 18 Aug 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?
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 Jingyuan Xie (13761056656 ext. +86, nephroxie@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of a decline in estimated glomerular filtration rate by > 50% from baseline (time frame: 1 year). 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 18 Aug 2026.