Clinical Trial: IgA Nephropathy Registration Initiative of High Quality (INSIGHT)

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational [Patient Registry]

Official Title: IgA Nephropathy Registration Initiative of High Quality (INSIGHT)

Brief 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 Summary: 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.
Sponsor: Sun Yat-sen University

Current Primary Outcome:

  • All-cause and cardiovascular mortality of IgAN patients [ Time Frame: 10 years ]
  • A composite renal outcome of IgAN patients [ Time Frame: 10 years ]
    The composite renal outcome defined as doubling of serum creatinine and ESRD (defined as initiation of dialysis or kidney transplantation).


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Sun Yat-sen University

Dates:
Date Received: December 21, 2016
Date Started: November 2012
Date Completion: December 2026
Last Updated: December 22, 2016
Last Verified: December 2016