Evaluating biomarkers in IgA nephropathy patients
IgA Nephropathy Biomarkers Evaluation Study (INTEREST)
This study is trying to see if certain blood and urine markers can help predict how kidney disease will progress in people with IgA nephropathy who still have normal kidney function.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2000 (estimated) |
| Ages | 14 Years and up |
| Sex | All |
| Sponsor | Sun Yat-sen University Academic / other |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT02954419 on ClinicalTrials.gov |
What this trial studies
This observational cohort study aims to investigate the relationship between blood and urine biomarkers, including genetic variants, and the long-term progression of kidney disease in 2000 Chinese patients diagnosed with IgA nephropathy who have relatively normal kidney function. The study focuses on understanding how these biomarkers can predict outcomes in patients with IgA nephropathy, a common cause of end-stage renal disease in China. By integrating data from whole genomic loci and serum and urine biomarkers, the study seeks to provide insights that could lead to better prognostic tools for managing this condition.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 14 years or older with biopsy-proven primary IgA nephropathy and an eGFR of 60 ml/min/1.73 m2 or higher.
Not a fit: Patients with secondary IgA nephropathy or those whose relatives have been diagnosed with biopsy-proven primary IgA nephropathy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to the identification of reliable biomarkers that help predict kidney disease progression in IgA nephropathy patients.
How similar studies have performed: Previous studies have identified genetic loci related to IgA nephropathy, but this study's comprehensive approach to integrating various biomarkers is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male or female individuals aged 14 years or older * Patients with biopsy-proven primary IgA nephropathy * A renal biopsy available for reviewing must include 10 or more glomeruli. * The first renal biopsy was performed within 3 years. * eGFR ≥ 60 ml/min/1.73 m2 (MDRD formula); * Individuals or their legal representative who are able to understand and have voluntarily signed the informed consent form (ICF). Exclusion Criteria: * Relatives were diagnosed with biopsy-proven primary IgA nephropathy; * Individuals had secondary IgA nephropathy due to diseases such as diabetes, chronic liver disease and systemic lupus erythematosus.
Where this trial is running
Guangzhou, Guangdong
- The First Affiliated Hospital,Sun Yat-sen University — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Principal investigator: Xue Qing Yu, M.D. & Ph.D. — First Affiliated Hospital, Sun Yat-Sen University
- Study coordinator: Xue Qing Yu, M.D. & Ph.D.
- Email: yuxq@mail.sysu.edu.cn
- Phone: 8620-87766335
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.