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Observational study of the efficacy and safety of Tetaticept in the treatment of lupus nephritis in the real world

Observational study of the efficacy and safety of Tetaticept in the treatment of lupus nephritis in the real world

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300071163
Enrollment
Unknown
Registered
2023-05-06
Start date
2022-08-24
Completion date
Unknown
Last updated
2023-06-04

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

Conditions

lupus nephritis

Interventions

Tetaticept treatment Group:N/A

Sponsors

Fujian Provincial Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Adult patients, regardless of gender; 2. The diagnosis of systemic lupus erythematosus combined with lupus nephritis meets the criteria of the American College of Rheumatology; 3. The patient was diagnosed with lupus nephritis by biopsy, which was confirmed to meet the 2003 ISN/RPS standard of the International Society of Nephrology/Society of Renal Pathology. 4. Volunteer to participate in this study and sign informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients requiring dialysis or kidney transplantation; 2. Allergy to the study drug; 3. Received live vaccine within 30 days prior to baseline; 4. Women who are pregnant or planning to become pregnant recently, or lactating women; 5. Patients with active hepatitis or a history of severe liver disease or disease; 6. Patients with immune deficiency, uncontrolled severe infection, and active or recurrent gastrointestinal ulcers; 7. Subjects who are participating in clinical studies of other drugs; In addition to the above, the investigators determined that there were other reasons for ineligibility for this clinical trial.

Design outcomes

Primary

MeasureTime frame
Urine protein;Creatinine;

Secondary

MeasureTime frame
Albumin;Complement C3;Complement C4;Anti-dsDNA;Anti-nuclear antibody;c reactive protein;erythrocyte sedimentation rate;IgG;IgM;IgA;

Countries

China

Contacts

Public ContactFu-Yuan Hong

Fujian Provincial Hospital

hongdoc@163.com+86 15960199966

Outcome results

None listed

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