NCT03001947

IgA Nephropathy Registration Initiative of High Quality (INSIGHT)

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 10,000 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 14 Years
• Healthy volunteers: Not accepted

Summary

The investigators are registering all biopsy-proven primary IgA nephropathy (IgAN) patients at recruited hospitals and developing a IgAN database in China. Patients will be follow-up every one year, and both baseline and follow-up information will be entered into the registration system. All-cause and cardiovascular mortality and a composite renal outcome of doubling of serum creatinine and end stage renal failure (ESRD, defined as initiation of dialysis or kidney transplantation) of IgAN patients will be compared using the IgAN database.

Detailed description

The investigators are registering all biopsy-proven primary IgA nephropathy (IgAN) patients, and developing a IgAN database in China. Patients' demographic characteristics (including age, gender, height, weight, BMI, smoking, drinking, and education), clinical characteristics (including systolic blood pressure, diastolic blood pressure, primary cause of ESRD, and lab measurements of serum and urine), complications, drug information at the baseline will be collected. Patients will be follow-up every one year, the demographic and clinical characteristics, complications and drug information of patients will be collected at each visit. The investigators also record the clinical events at each visit, such as mortality (including all-cause mortality and cardiovascular disease mortality), ESRD (defined as initiation of dialysis or kidney transplantation) and hospitalization for any cause. All-cause and cardiovascular mortality and a composite renal outcome of doubling of serum creatinine and ESRD for IgAN patients will be compared using the IgAN database.

Conditions

• IgA Nephropathy

Interventions

Type	Name	Description
OTHER	No intervention	Registration of all IgAN patients in the First Affiliated Hospital of Sun Yat-sen University and other hospitals which have signed the contract in China.

Timeline

• Start date: 2012-11-01
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2016-12-23
• Last updated: 2020-10-22

Locations

1 site across 1 country: China