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

NCT07031674 | Completed

• 1 other identifier: YXLL-KY-2025(102)
• Study Type: observational
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Lupus Nephritis; Belimumab

Outcome Measures

Primary Outcomes (1)

• The response rate for major kidney treatments

  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.

  From baseline to the end of 1-year treatment period

Secondary Outcomes (1)

• Complete renal response rate

  From baseline to the end of 1-year treatment period

Study Arms (2)

The Telitacicept group

The participants in the study had previously used telitacicept as a therapeutic drug.

The Belimumab group

The participants in the study had previously used belimumab as a therapeutic drug.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The inclusion period is from March 1, 2021 to March 1, 2024. Patients who visited the First Affiliated Hospital of Shandong University Medical University, the Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Wuhan University People's Hospital, and the Department of Nephrology of Capital Medical University Affiliated Beijing Friendship Hospital for clinical diagnosis of lupus nephritis were included.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yipeng Liu: lead
• Renmin Hospital of Wuhan University: collaborator
• Affiliated Hospital of Shandong University of Traditional Chinese Medicine: collaborator
• Beijing Friendship Hospital: collaborator

Study Sites (1)

Qianfoshan Hospital

Jinan, Shandong, 250000, China

Location

MeSH Terms

Conditions

Lupus Nephritis

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lupus Erythematosus, Systemic; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: June 13, 2025
• First Posted: June 22, 2025
• Study Start: October 1, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: February 2, 2026

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)