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IgA Nephropathy Registration Initiative of High Quality (INSIGHT)

IgA Nephropathy Registration Initiative of High Quality (INSIGHT)

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03001947
Enrollment
10000
Registered
2016-12-23
Start date
2012-11-01
Completion date
2029-12-01
Last updated
2026-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

IgA Nephropathy

Keywords

IgA nephropathy, All-cause mortality, Cardiovascular mortality, A composite renal outcome

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 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.

Interventions

OTHERNo 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.

Sponsors

Sun Yat-sen University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
14 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
All-cause and cardiovascular mortality of IgAN patients10 years
A composite renal outcome of IgAN patients10 yearsThe composite renal outcome defined as doubling of serum creatinine and ESRD (defined as initiation of dialysis or kidney transplantation).

Countries

China

Contacts

CONTACTXueqing Yu, M.D. & Ph.D
yuxq@mail.sysu.edu.cn
CONTACTQiongqiong Yang, M.D. & Ph.D
qiongqyzzm@qq.com8620-87755766

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 16, 2026