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A real-world research protocol based on population cohort assessment of serum antiphospholipid antibodies to predict early renal damage in systemic lupus erythematosus

A real-world research protocol based on population cohort assessment of serum antiphospholipid antibodies to predict early renal damage in systemic lupus erythematosus

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100047308
Enrollment
Unknown
Registered
2021-06-12
Start date
2021-06-30
Completion date
Unknown
Last updated
2022-02-01

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

Conditions

Systemic lupus erythematosus

Interventions

case series:Nil

Sponsors

Shenzhen Second People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
14 Years to 65 Years

Inclusion criteria

Inclusion criteria: Retrospective research: 1. Aged 14 to 65 years old, regardless of gender or ethnicity; 2. Diagnosed as systemic lupus erythematosus: according to the 2009 ACR/EULAR classification and diagnosis criteria for SLE; 3. All patients were tested for anti-phospholipid antibodies, including aCL, LA, and anti-ß2GP1; Prospective research: 1. Aged 14 to 65 years old, regardless of gender or ethnicity; 2. Diagnosed as systemic lupus erythematosus: according to the 2009 ACR/EULAR classification and diagnosis criteria for SLE; 3. Enrollment at baseline did not suffer from kidney injury (diagnostic criteria for lupus nephritis: 24-hour urine protein quantitative >= 0.5g/24h or confirmed by renal biopsy as lupus nephritis); 4. All patients were tested for anti-phospholipid antibodies, including aCL, LA, and anti-ß2GP1; 5. Sign the written consent, patients under the age of 18 need to have a legal guardian to sign an informed consent form at the same time.

Exclusion criteria

Exclusion criteria: 1. Patients with malignant tumors; 2. eGFR< 30 ml/min/1.73m2 (calculated using CKD EPI formula); 3. Severe active central nervous system (CNS) lupus (including epilepsy, psychosis, organic brain Syndrome, cerebrovascular accident, encephalitis or central nervous system vasculitis); 4. The patient has acute or chronic infection that needs treatment, and the investigator judges it is not suitable for inclusion in the study; 5. Pregnancy, breastfeeding.

Design outcomes

Primary

MeasureTime frame
24-hour urine protein quantification;

Countries

China

Contacts

Public ContactWang Meiying

Shenzhen Second People's Hospital

wmy99wmy99@163.com+86 13723769919

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026