High Quality Evidence of Chinese Lupus Nephritis (HELP)

Lupus Nephritis Clinical Trial

Official title:

High Quality Evidence of Chinese Lupus Nephritis (HELP)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03001973
• Other study ID #: HELP
• Status: Recruiting
• Start date: November 2013
• Est. completion date: December 2026

Study information

• Verified date: October 2020
• Source: Sun Yat-sen University
• Contact: Xueqing Yu, M.D. & Ph.D
• Email: yuxq[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: December 2026
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years and older

Eligibility

Inclusion Criteria:

• Patients who diagnosis as lupus nephritis

Exclusion Criteria:

• No

Related Conditions & MeSH terms

• Lupus Nephritis
• Nephritis

Intervention

Other:
• No Intervention
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.

Locations

Country	Name	City	State
China	The First Affiliated Hospital, Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-cause mortality and cardiovascular mortality of LN patients		10years
Primary	A composite renal outcome of LN patients	The composite renal outcome defined as doubling of serum creatinine and ESRD (defined as initiation of dialysis or kidney transplantation).	10years