ClinicalTrials.gov
ClinicalTrials.gov Menu

High Quality Evidence of Chinese Lupus Nephritis (HELP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03001973
Recruitment Status : Recruiting
First Posted : December 23, 2016
Last Update Posted : September 6, 2018
Sponsor:
Information provided by (Responsible Party):
Xue Qing Yu, Sun Yat-sen University

Brief 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.

Condition or disease Intervention/treatment
Lupus Nephritis Other: No Intervention

Detailed 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.

Study Type : Observational
Estimated Enrollment : 5000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: High Quality Evidence of Chinese Lupus Nephritis (HELP)
Actual Study Start Date : November 2013
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2026

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
LN patients
Patients diagnosis as lupus nephritis
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.




Primary Outcome Measures :
  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).


Biospecimen Retention:   Samples With DNA
The serum, urine, DNA and renal tissue will be collected.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   14 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Lupus nephritis patients
Criteria

Inclusion Criteria:

  • Patients who diagnosis as lupus nephritis

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03001973


Contacts
Contact: Xueqing Yu, M.D. & Ph.D yuxq@mail.sysu.edu.cn
Contact: Wei Chen, M.D. & Ph.D 8620-87755766 ext 8843 vvchen66@qq.com

Locations
China, Guangdong
The First Affiliated Hospital, Sun Yat-sen University Recruiting
Guangzhou, Guangdong, China, 510080
Contact: Xueqing Yu, M.D. & Ph.D.       yuxq@mail.sysu.edu.cn   
Sponsors and Collaborators
Sun Yat-sen University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Xue Qing Yu, Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT03001973     History of Changes
Other Study ID Numbers: HELP
First Posted: December 23, 2016    Key Record Dates
Last Update Posted: September 6, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by Xue Qing Yu, Sun Yat-sen University:
Lupus nephritis
Patient survival
Renal survival

Additional relevant MeSH terms:
Nephritis
Lupus Nephritis
Kidney Diseases
Urologic Diseases
Glomerulonephritis
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases