Comparing two biologic induction regimens and standard mycophenolate therapy for active proliferative lupus nephritis over six months
The Efficacy and Safety of Biologics (Belimumab/ Telitacicept) Induction Therapy in Proliferative Lupus Nephritis Patients for 6 Months Compared With Mycophenolate Mofetil Treatment
This trial will test whether biologic induction therapy with belimumab or telitacicept leads to better kidney responses over six months than standard mycophenolate-based treatment in people aged 14–65 with active proliferative lupus nephritis.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 14 Years to 65 Years |
| Sex | All |
| Sponsor | Nanjing University School of Medicine Academic / other |
| Drugs / interventions | belimumab, prednisone |
| Locations | 1 site (Nanjing, Jiangsu) |
| Trial ID | NCT07340463 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: People aged 14–65 with SLE who have biopsy-confirmed active Class III or IV (±V) lupus nephritis, significant proteinuria (>1 g/day), and an active disease score (SLE-DAI >6) are the intended candidates.
Not a fit: Patients with severe concomitant organ damage or lupus crisis, significant hematologic or liver abnormalities, recent intensive immunotherapies, or without biopsy-proven proliferative lupus nephritis are unlikely to benefit from this trial.
Why it matters
Potential benefit: If successful, the biologic regimens could increase complete kidney response rates and offer alternative induction options that may improve outcomes for people with proliferative lupus nephritis.
How similar studies have performed: Belimumab added to standard therapy has shown improved renal outcomes in other trials, while telitacicept is a newer dual-target biologic with promising but more limited data in lupus nephritis.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Nanjing, Jiangsu
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.