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NCT Number: NCT03001947

IgA Nephropathy Registration Initiative of High Quality (INSIGHT)

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.

Recruiting

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Key information

Age range

14 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The First Affiliated Hospital, Sun Yat-Sen University

Guangzhou, Guangdong, 510080, China

Location status: Recruiting

Location contact

Xueqing Yu, M.D. & Ph.D

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Biopsy-proven primary IgAN patients;
  • age ≥14 years old
  • 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.

Treatment and study plan

No intervention

Other

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.

Primary outcomes

  1. All-cause and cardiovascular mortality of IgAN patients

    Time frame: 10 years

  2. 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Qiongqiong Yang, M.D. & Ph.D

CONTACT

[email protected]

8620-87755766 ext. 843

Xueqing Yu, M.D. & Ph.D

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Important dates

Study start
2012
Primary completion
2026
Study completion
2026
First posted
Dec 23, 2016
Registry last updated
Oct 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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