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OpenTrials
Completed

NCT Number: NCT07031674

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

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.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Qianfoshan Hospital

Jinan, Shandong, 250000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. The response rate for major kidney treatments

    Time frame: From baseline to the end of 1-year treatment period

    • 24-hour urine PCR ≤ 0.7 g/g (70 mg/mmol);
    • eGFR decline does not exceed 20% of the baseline or is ≥ 60 ml/min/1.73 m2;
    • No rescue treatment was adopted due to treatment failure.

Secondary outcomes

  1. Complete renal response rate

    Time frame: From baseline to the end of 1-year treatment period

    • 24-hour urine PCR < 0.5 g/g (50 mg/mmol);
    • Renal function is stable or has improved (by no more than 10%-15% compared to the baseline).

Sponsors and collaborators

Lead sponsor

Yipeng Liu

Other

Collaborators

  • Affiliated Hospital of Shandong University of Traditional Chinese Medicine
  • Beijing Friendship Hospital
  • Renmin Hospital of Wuhan University

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 22, 2025
Registry last updated
Feb 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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