Comparing Efficacy and Safety of Telitacicept and Belimumab in Lupus Nephritis: A Retrospective Multicenter Cohort Study.

Active, not recruiting

• Conditions: Lupus Nephritis; Belimumab

• Registration Number: NCT07031674
• Lead Sponsor: Yipeng Liu

Brief Summary

The objective of this observational study is to compare the efficacy and safety of telitacicept and belimumab in the treatment of lupus nephritis in patients aged 18-65 years with lupus nephritis. The main question it aims to answer is: What are the response rates of the two drugs for the main renal therapy in the lupus nephritis population? Which drug has better efficacy and safety? This study is a retrospective study. The participants will not receive any treatment.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-05
• Study Start: 2025-05-01
• Study First Submitted: 2025-06-13
• Study First Submitted QC: 2025-06-13
• Last Update Submitted: 2025-06-13
• Study First Posted: 2025-06-22
• Last Update Posted: 2025-06-22
• Primary Completion: 2025-06-30
• Study Completion: 2025-08-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

• Age range: 18 - 65 years old;
• Meets the revised SLE classification criteria of the American College of Rheumatology in 1997 or the SLE diagnostic classification criteria issued by EULAR/ACR in 2019;
• Urine protein quantification ≥ 1g/d, or urine PCR ≥ 1g/g, or qualitative urine protein test in urine routine ≥ 1+;
• Patients who have been using telitacicept or belimumab for at least 12 weeks.

Exclusion Criteria

• Having active central nervous system diseases;
• eGFR < 30 mL/min/1.73m², or undergoing hemodialysis or kidney transplantation;
• Pregnant women, or those who are about to become pregnant in the near future, or lactating women;
• Participants who are simultaneously participating in other clinical studies;
• Patients who have received telitacicept or belimumab treatment for less than 12 weeks.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The response rate for major kidney treatments	From baseline to the end of 1-year treatment period	1. 24-hour urine PCR ≤ 0.7 g/g (70 mg/mmol); 2. eGFR decline does not exceed 20% of the baseline or is ≥ 60 ml/min/1.73 m2; 3. No rescue treatment was adopted due to treatment failure.

Secondary Outcome Measures

Name	Time	Method
Complete renal response rate	From baseline to the end of 1-year treatment period	1. 24-hour urine PCR \< 0.5 g/g (50 mg/mmol); 2. Renal function is stable or has improved (by no more than 10%-15% compared to the baseline).

Trial Locations

Locations (1)

Qianfoshan Hospital; 🇨🇳 Jinan, Shandong, China