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IgA Nephropathy Registration Initiative of High Quality (INSIGHT)

Sun Yat-sen University logo

Sun Yat-sen University

Status

Enrolling

Conditions

IgA Nephropathy

Treatments

Other: No intervention

Study type

Observational

Funder types

Other

Identifiers

NCT03001947
INSIGHT

Details and patient eligibility

About

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.

Full 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.

Enrollment

10,000 estimated patients

Sex

All

Ages

14+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

10,000 participants in 1 patient group

IgAN patients
Description:
Biopsy-proven primary IgAN patients
Treatment:
Other: No intervention

Trial contacts and locations

1

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Central trial contact

Qiongqiong Yang, M.D. & Ph.D; Xueqing Yu, M.D. & Ph.D

Data sourced from clinicaltrials.gov

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