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NCT Number: NCT03001973

High Quality Evidence of Chinese Lupus Nephritis (HELP)

The investigators are registering LN patients at recruited hospitals and developing a LN database in China. Patients will be follow-up every year, and both baseline and follow-up information will be entered into the registration system.

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 Lupus nephritis (LN) and developing a LN database in China. Patients' demographic characteristics (including age, gender, height, weight, BMI, smoking, drinking, and education etc.), clinical characteristics (including systolic blood pressure, diastolic blood pressure, and lab measurements of whole blood, serum, urine etc.), complications, drug information at the baseline will be collected. Patients will be follow-up every year, the demographic and clinical characteristics, complications; drug information of patients will be collected at each visit. We will also record the outcome at each visit, such as mortality (including all-cause mortality and cardiovascular disease mortality), end-stage renal disease (ESRD) or serum creatinine doubling. The patient survival and renal survival will be compared using the LN database.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients who diagnosis as lupus nephritis

Exclusion criteria

  • No

Treatment and study plan

No intervention

Other

Registration of all LN 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 mortality and cardiovascular mortality of LN patients

    Time frame: 10years

  2. A composite renal outcome of LN patients

    Time frame: 10years

    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.

Wei Chen, M.D. & Ph.D

CONTACT

[email protected]

8620-87755766 ext. 8843

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
2013
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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