Clinical Trials Logo

Clinical 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. 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.

Clinical Trial 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

Related Conditions & MeSH terms

NCT number NCT04858724
Study type Observational [Patient Registry]
Source Ruijin Hospital
Contact Jingyuan Xie
Phone 13761056656
Email [email protected]
Status Recruiting
Start date December 1, 2020
Completion date September 30, 2030

See also
  Status Clinical Trial Phase
Withdrawn NCT02433236 - Open Label Study of Fostamatinib in the Treatment of IgA Nephropathy Phase 2
Recruiting NCT02231125 - Efficacy and Safety of Abelmoschus Manihot for IgA Nephropathy Phase 4
Completed NCT01502579 - An Observational Study of IgA Nephropathy: Pathological Variants and Clinical Data N/A
Not yet recruiting NCT01203007 - Diet Intervention in Food Sensitive Patients With IgA Nephropathy N/A
Terminated NCT01129557 - Aldosterone Breakthrough During Diovan, Tekturna, and Combination Therapy in Patients With Proteinuric Kidney Disease Phase 4
Completed NCT00657059 - Mycophenolate Mofetil (MMF) in Patients With IgA Nephropathy (IgAN) Phase 3
Recruiting NCT04684745 - Open-Label Extension Study of BION-1301 in IgA Nephropathy Phase 2
Completed NCT03719443 - First in Human Study to Assess Safety of VIS649 in Healthy Subjects Phase 1
Withdrawn NCT02052219 - BRILLIANT-SC: A Study of the Efficacy and Safety of Blisibimod Administration in Subjects With IgA Nephropathy Phase 3
Completed NCT02112838 - Safety and Efficacy Study of Fostamatinib to Treat Immunoglobin A (IgA) Nephropathy Phase 2
Completed NCT00767221 - Oral Treatment With PL-56 in Patients With IgA Nephropathy - an Explorative Study Phase 2
Recruiting NCT04438603 - The Applicaiton of Immune Repertoire in the Diagnosis and Disease Monitoring of IgA Nephropathy
Terminated NCT04042623 - Study of Safety and Efficacy of AVB-S6-500 in Patients With IgA Nephropathy Phase 2
Recruiting NCT03633864 - Fecal Microbiota Transplantation for Refractory IgA Nephropathy Phase 2
Recruiting NCT02954419 - IgA Nephropathy Biomarkers Evaluation Study (INTEREST)
Recruiting NCT03001947 - IgA Nephropathy Registration Initiative of High Quality (INSIGHT)
Completed NCT01224028 - A Study to Evaluate the Efficacy and Safety of Tacrolimus in Korean Nephropathy Patients Phase 2
Completed NCT00549692 - Efficacy and Safety of Omega-3 Fatty Acids(Omacor®) for the Treatment of Immunoglobulin A Nephropathy Phase 3
Not yet recruiting NCT02662283 - Validity and Security of Reh-acteoside Therapy for Patients of IgA Nephropathy Phase 2/Phase 3
Completed NCT00426348 - A Study of the Antioxidant Probucol Combined With Valsartan in Patients With IgA Nephropathy Phase 4