Registering patients with IgA nephropathy in China
IgA Nephropathy Registration Initiative of High Quality (INSIGHT)
Sun Yat-sen University · NCT03001947
This study is trying to gather information from patients with IgA nephropathy in China to see how the condition affects their long-term health and outcomes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 10000 (estimated) |
| Ages | 14 Years and up |
| Sex | All |
| Sponsor | Sun Yat-sen University (other) |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT03001947 on ClinicalTrials.gov |
What this trial studies
This initiative involves registering all biopsy-proven primary IgA nephropathy (IgAN) patients at selected hospitals in China to develop a comprehensive IgAN database. Patients will be followed up annually, with data collected on their demographic and clinical characteristics, complications, and drug information. The study aims to compare all-cause and cardiovascular mortality, as well as composite renal outcomes, including doubling of serum creatinine and end-stage renal failure (ESRD), using the collected data. This observational approach will help in understanding the long-term outcomes of IgAN patients.
Who should consider this trial
Good fit: Ideal candidates for this initiative are individuals aged 14 years and older with biopsy-proven primary IgA nephropathy.
Not a fit: Patients with secondary causes of IgA deposition or severely reduced kidney function (eGFR ≤ 15 ml/min/1.73m²) at the time of biopsy may not benefit from this initiative.
Why it matters
Potential benefit: If successful, this initiative could provide valuable insights into the long-term outcomes and mortality risks associated with IgA nephropathy, potentially guiding better management strategies for patients.
How similar studies have performed: While this approach is observational and primarily focused on data collection, similar registries have shown success in understanding chronic kidney diseases and their outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Biopsy-proven primary IgAN patients; 2. age ≥14 years old 3. Adequate biopsy sample containing ≥8 glomeruli. Exclusion Criteria: Secondary causes of mesangial IgA deposition, such as Henoch-Schonlein purpura nephritis, systemic lupus erythematosus, liver cirrhosis and et al; eGFR≤15ml/min/1.73m2 at biopsy.
Where this trial is running
Guangzhou, Guangdong
- The First Affiliated Hospital, Sun Yat-Sen University — Guangzhou, Guangdong, China (RECRUITING)
Study contacts
- Study coordinator: Xueqing Yu, M.D. & Ph.D
- Email: yuxq@mail.sysu.edu.cn
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: IgA Nephropathy, IgA nephropathy, All-cause mortality, Cardiovascular mortality, A composite renal outcome