The Chinese Registry of Prognostic Study of IgA Nephropathy (CRPIGA)

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Brief Title

The Chinese Registry of Prognostic Study of IgA Nephropathy (CRPIGA)

Official Title

Construction of a Multi-center Database for Primary IgA Nephropathy

Brief 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. Establish a standardized IgAN database for combined Hospital Information System and the
           big data platform of the Medical Federation.

        4. 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 Type

Observational [Patient Registry]


Primary Outcome

The proportion of a decline in estimated glomerular filtration rate by > 50% from baseline

Secondary Outcome

 Incidence of cardiovascular events

Condition

IgA Nephropathy



Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

2000

Start Date

December 1, 2020

Completion Date

September 30, 2030

Primary Completion Date

September 30, 2022

Eligibility Criteria

        Inclusion Criteria:

          1. No age limit, no gender limit;

          2. Kidney biopsy confirmed primary IgA nephropathy;

          3. Sign the informed consent form voluntarily

        Exclusion Criteria:

          1. IgA nephropathy is secondary to systemic diseases such as systemic lupus erythematosus
             and allergic purpura;

          2. IgAN is clinically diagnosed but not confirmed by pathology;

          3. The patient refuses to participate;

          4. Patients judged by other investigators to be unsuitable for inclusion in the study.
      

Gender

All

Ages

N/A - N/A

Accepts Healthy Volunteers

No

Contacts

Jingyuan Xie, 13761056656, [email protected]

Location Countries

China

Location Countries

China

Administrative Informations


NCT ID

NCT04858724

Organization ID

CRPIGA


Responsible Party

Sponsor

Study Sponsor

Ruijin Hospital

Collaborators

 RenJi Hospital

Study Sponsor

Jingyuan Xie, Principal Investigator, Ruijin Hospital


Verification Date

April 2021