Comparing two biologic induction regimens and standard mycophenolate therapy for active proliferative lupus nephritis over six months

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-center, prospective, randomized, controlled Phase 2 trial that compares two biologic-based induction regimens (belimumab or telitacicept with glucocorticoids) against standard-of-care mycophenolate mofetil (MMF) induction and a triple-combination regimen in patients with active proliferative lupus nephritis. Eligible participants have biopsy-proven Class III or IV (±V) lupus nephritis, significant proteinuria, and active SLE. The primary endpoint is the complete renal response rate at six months, with secondary endpoints including partial and overall renal responses over time, time to response, changes in clinical and immunological markers, and safety comparisons. Treatments and follow-up visits occur at the single trial site in Nanjing, with monthly assessments through month six.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 1.Signed written informed consent form. 2.Age 14-65 years (inclusive), any gender. 3.Meets the American College of Rheumatology (ACR) SLE diagnostic criteria (1997).

  4.All patients have biopsy-confirmed class III/IV ± V LN within the past six months.

  5.SLE-DAI score \> 6. 6.Urine protein quantification \> 1.0 g/d.

Exclusion Criteria:

* 1.Estimated glomerular filtration rate (eGFR) ≥45 ml/min/1.73 m². 2.Patients who have received renal replacement therapy, plasma exchange, immunoadsorption, or high-dose intravenous immunoglobulin (100g) within the past 2 months.

  3.Patients with concomitant critical organ damage or lupus crisis (e.g., pulmonary hemorrhage, encephalopathy, heart failure) deemed unsuitable for clinical trial participation by the investigator.

  4.Hematological abnormalities: White blood cells \<3000/μL, absolute neutrophil count \<1500/μL, or lymphocytes \<800/μL, platelet count \<50,000/μL (unless due to SLE activity).

  5.Liver function abnormalities: ALT, AST, or bilirubin levels exceeding 2 times the upper limit of normal.

  6.Known allergy or contraindication to any component of belimumab and/or telitacicept.

  7.Active infection or intravenous antibiotic use within 1 month prior to enrollment.

  8.Pregnant or breastfeeding women. 9.Current or within the past 3 months: Active hepatitis B, hepatitis C, tuberculosis, cytomegalovirus pneumonia, active fungal infection, syphilis infection, or HIV infection; active peptic ulcer; history of drug abuse or alcoholism; severe malnutrition (BMI \<16 kg/m²).

  10.Other conditions: Severe cardiovascular disease potentially life-threatening; chronic obstructive pulmonary disease, or asthma/allergic diseases requiring long-term oral steroid treatment; malignant hypertension; history of malignancy within the past 5 years (except for completely treated basal cell or squamous cell skin cancer or cervical intraepithelial neoplasia).

  11.Other situations deemed unsuitable for enrollment by the investigator.

Where it's running

• Clinical Research Ethics Committee of the General Hospital of Eastern Theater Command of the People's Liberation Army
  Nanjing, Jiangsu, China Recruiting

Study contacts

• Study coordinator: Zhi-Hong Liu, MD
• Email: njrin@nju.edu.cn
• Phone: 86+025-80860218

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.