A prospective clinical observational study of patients with systemic lupus erythematosus and lupus nephritis

Status

Active, not recruiting

Phases

Phase 1

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR2400092484

Enrollment

Unknown

Registered

2024-11-18

Start date

2024-11-18

Completion date

Unknown

Last updated

2024-12-02

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

Conditions

Systemic lupus erythematosus, lupus nephritis

Interventions

?Control group: 48 weeks of treatment with glucocorticoids + immunosuppressants (MMF &== & FK &== & CsA &== & CTX) :None

?Tetrasip 160mg &== & 160mg group: 48 weeks of treatment with 160mg Tetrasip:None

?Tetrasip 160mg &== & 80mg group: 24 weeks of treatment with 160mg Tetrasip + 80mg Tetrasip:None

Eligibility

Sex/Gender

All

Age

18 Years to 85 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: ? Patients who have been admitted to the outpatient clinic and hospitalization of the Department of Nephrology, West China Hospital, Sichuan University since March 1, 2024 and have been pathologically diagnosed with lupus nephritis (LN) by renal puncture biopsy; ? Patients who have been admitted to the outpatient clinic and hospitalization of the Department of Nephrology, West China Hospital, Sichuan University since March 1, 2024 and have been diagnosed with systemic lupus erythematosus (SLE) and have undergone renal puncture biopsy; ? Aged 18 years or older, regardless of gender, race, etc.; ? Patients who are followed up regularly, that is, at least every 3 months within one year after diagnosis until one year of follow-up is completed (prospective cohort). Demographic, clinical, and laboratory data will be collected at baseline, and relevant laboratory data will be collected every 3-6 months thereafter until the study is completed.

Exclusion criteria

Exclusion criteria: Exclusion criteria: ? Other autoimmune diseases or secondary kidney diseases, such as hypertensive nephropathy, diabetic nephropathy, Henoch-Schonlein purpura nephropathy, lupus nephritis, hepatocellular renal damage, primary vasculitis renal damage, rheumatoid arthritis renal damage, etc.; ? Patients who cannot be followed up regularly.

Design outcomes

Primary

Measure	Time frame
Complete remission rate;Partial response rate;Lupus Low Disease Activity Scale (LLDAS);	—

Secondary

Measure	Time frame
Incidence of adverse events;	—

Countries

China

Contacts

Public ContactQinwei

Department of Nephrology, West China Hospital, Sichuan University

qinweihx@scu.edu.cn+86 189 8060 2119

Outcome results

None listed

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