A Phase 2 interventional study of Glucocorticoids and belimumab in Systemic Lupus Erythematosus (SLE) and Lupus Nephritis (LN), sponsored by Nanjing University School of Medicine. Recruiting at 1 site in China. Open to participants aged 14 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-03-12.
Sponsored by Nanjing University School of Medicine · Phase 2, Interventional, and Treatment
Study Objectives Primary Objective: To compare the 6-month complete renal response (CRR) rate among patients receiving biologic-based induction therapy, SOC induction therapy, and triple-combination induction therapy.
Secondary Objectives: To compare the rates of partial renal response (PRR) and overall renal response (ORR) at monthly intervals up to Month 6; to assess the time to achieve CRR/PRR; to evaluate changes in clinical and immunological parameters from baseline; and to compare the safety profiles of the three treatment regimens.
Treatment Groups and Intervention
Eligible patients will be randomized in a 2:2:1 ratio to one of three treatment arms for a 6-month induction period:
Biologics Group (n≈20): Glucocorticoids + either Belimumab or Telitacicept. SOC Group (n≈20): Glucocorticoids + Mycophenolate Mofetil (MMF). Triple Therapy Group (n≈10): Glucocorticoids + MMF + either Belimumab or Telitacicept.
The choice between Belimumab and Telitacicept within the Biologics and Triple Therapy groups will be determined jointly by the investigator and the patient.
Study Medications \& Administration Glucocorticoids: All patients will receive oral prednisone (or equivalent) starting at 0.5 mg/kg/day (max 40 mg/day), with a mandatory taper to ≤5 mg/day by Month 4 and stable dosing from Months 5-6. Intravenous methylprednisolone pulses are permitted per investigator discretion.
Mycophenolate Mofetil (MMF): Administered only in the SOC and Triple Therapy groups. The target dose is 1.5-2.0 g/day, maintained until the end of the treatment period.
Belimumab: Administered via intravenous infusion at 10 mg/kg (600 mg/dose) every 2 weeks.
Telitacicept: Administered via subcutaneous injection at 160 mg once weekly. Patients in the Biologics or SOC groups showing no response by Month 3 may directly switch to the Triple Therapy regimen.
The primary endpoint is the proportion of patients achieving Complete Renal Response (CRR) at Month 6. CRR is strictly defined as:
24-hour urine protein \<0.5 g/d, AND Estimated Glomerular Filtration Rate (eGFR) ≥85% of the baseline value, AND No requirement for rescue therapy or premature treatment withdrawal. 7. Secondary Efficacy \& Safety Assessments Key secondary efficacy assessments include monthly CRR, PRR, and ORR rates; time to response; incidence of renal-related events; and changes in proteinuria, eGFR, serum creatinine, and disease activity scores (SELENA-SLEDAI, BILAG-2004, PGA). Safety will be evaluated through the incidence and severity of adverse events, with special attention to infections, infusion/injection reactions, and metabolic parameters.
8. Statistical Considerations This is an exploratory study with a planned enrollment of 40-50 patients. The primary analysis will use the Full Analysis Set (FAS) under the intention-to-treat principle. The difference in the Month 6 CRR rate among the three groups will be analyzed using the Chi-square test. Time-to-event data will be analyzed using the Kaplan-Meier method with Log-rank test for comparisons.
9. Hypothesis: This study protocol outlines a head-to-head comparison of novel biologic-based induction strategies against current SOC for active LN. It aims to generate critical preliminary data on whether glucocorticoids combined with a biologic (Belimumab or Telitacicept) alone can induce effective renal remission, potentially offering a targeted treatment option with a different safety profile compared to conventional immunosuppressive therapy. The results may inform the design of larger, confirmatory trials in LN management.
340 studies on the registry are indexed under Lupus Nephritis; 135 are open to participants now.
This study's planned enrollment of 50 is close to the median of 48 across 242 interventional studies indexed under Lupus Nephritis.
Browse Lupus Nephritis studies →Nanjing University School of Medicine is the lead sponsor of 39 studies on the registry; 5 are open to participants now.
Compared within Lupus Nephritis, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Lupus Erythematosus, Systemic. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
1.Signed written 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 -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 (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, \<1500/μL, or lymphocytes \<800/μL, count \<50,000/μL (unless due to SLE activity).
5.Liver function abnormalities: , AST, or levels exceeding 2 times the .
6.Known allergy or 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 , , tuberculosis, cytomegalovirus pneumonia, active fungal infection, syphilis infection, or infection; active peptic ulcer; history of drug abuse or alcoholism; severe malnutrition ( \<16 kg/m²).
10.Other conditions: Severe cardiovascular disease potentially life-threatening; , or asthma/allergic diseases requiring long-term oral treatment; malignant hypertension; history of 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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Glucocorticoids combined with a biologic agent (Belimumab or Telitacicept). All subjects receive oral glucocorticoids (starting dose 0.5 mg/kg/day, ≤40 mg/day, planned taper to ≤5 mg/day by Month 4). Combined with one biologic agent: Belimumab (IV infusion, 10 mg/kg/dose, every 2 weeks) or Telitacicept (subcutaneous injection, 160 mg/dose, once weekly). The specific biologic is chosen through discussion between the investigator and the patient. If no response after 3 months of induction therapy, subjects may switch to the Triple Therapy Group.
Drug: Glucocorticoids · Biological: belimumab · Biological: Telitacicept
Glucocorticoids combined with Mycophenolate Mofetil (Standard of Care regimen). All subjects receive the same oral glucocorticoid regimen as the Biologics Group. Combined with Mycophenolate Mofetil (MMF), target dose 1.5-2.0 g/day, administered orally in two divided doses. If no response after 3 months of induction therapy, subjects may switch to the Triple Therapy Group.
Drug: Glucocorticoids · Drug: Mycophenolate mofetil (MMF)
Glucocorticoids combined with Mycophenolate Mofetil and a biologic agent (Belimumab or Telitacicept). All subjects receive the same oral glucocorticoid regimen as the other groups. Combined with Mycophenolate Mofetil (MMF) (target dose 1.5-2.0 g/day) and one biologic agent (Belimumab, every 2 weeks; or Telitacicept, once weekly). The specific biologic is chosen through discussion between the investigator and the patient. This group is both one of the initially randomized arms and the rescue therapy arm for non-responders from the other two groups.
Drug: Glucocorticoids · Biological: belimumab · Biological: Telitacicept · Drug: Mycophenolate mofetil (MMF)
Background therapy for all study arms. All subjects receive glucocorticoid therapy. The oral starting dose is prednisone 0.5 mg/kg/day (or equivalent), not exceeding 40 mg/day. Planned taper to ≤5 mg/day by Month 4, with stable dosing from Months 5-6. The tapering speed is determined by investigator assessment during the study. Permitted at investigator's discretion: intravenous methylprednisolone pulse therapy (dose 0.25-3.0g).
Also known as: Corticosteroids
A humanized monoclonal antibody targeting B-cell activating factor (BAFF). Used in the "Biologics Group" and the "Triple Therapy Group". Administered via intravenous infusion every 2 weeks at a dose of 10 mg/kg (600mg/dose) for 6 months. Premedication with dexamethasone and antihistamines is required for the first infusion to prevent allergic reactions (dexamethasone may be omitted for subsequent infusions if no prior reaction).
Also known as: Benlysta
A TACI-Fc fusion protein that neutralizes both BAFF and APRIL cytokines. Used in the "Biologics Group" and the "Triple Therapy Group". Administered via subcutaneous injection once weekly at a dose of 160mg for 6 months.
An immunosuppressive agent. Used in the "Standard of Care (SOC) Group" and the "Triple Therapy Group". Administered orally in two divided daily doses, target dose 1.5-2.0 g/day. Maintained at the target dose until the end of the treatment period. Dose adjustment or brief interruption (preferably not exceeding 14 days) is permitted in case of specific hematologic toxicity or infectious complications.
Complete Renal Response (CRR) Rate at Month 6
Proportion of patients achieving Complete Renal Response. CRR is defined as: 24-hour urine protein \< 0.5 g/d, AND estimated glomerular filtration rate (eGFR) ≥ 85% of the baseline value, AND no receipt of rescue therapy or premature withdrawal from treatment.
Time frame: From Baseline to Month 6
Partial Renal Response (PRR) Rate at Months 1, 2, 3, 4, 5, and 6
Proportion of patients achieving Partial Renal Response. PRR is defined as: ≥50% reduction in 24-hour urine protein from baseline, AND eGFR ≥ 85% of the baseline value, AND no receipt of rescue therapy or premature withdrawal from treatment.
Time frame: From Baseline to Months 1, 2, 3, 4, 5, and 6
Overall Renal Response (ORR) Rate at Months 1, 2, 3, 4, 5, and 6
Proportion of patients achieving Overall Renal Response. ORR is defined as achieving either Partial Renal Response (PRR) or Complete Renal Response (CRR).
Time frame: From Baseline to Months 1, 2, 3, 4, 5, and 6
Time to Achieve Complete or Partial Renal Response
Time from randomization to the first achievement of either Complete Renal Response or Partial Renal Response.
Time frame: From randomization up to Month 6
Proportion of Patients with Renal-Related Events by Month 6
Proportion of patients experiencing at least one renal-related event. Renal-related event is defined as: ① Death; ② Worsening proteinuria (≥50% increase in 24-hour urine protein from baseline AND value ≥3 g/g); ③ Worsening eGFR (≥30% decrease in eGFR from baseline AND value \<60 mL/min/1.73 m²); ④ Receipt of rescue therapy.
Time frame: From Baseline to Month 6
Change from Baseline in 24-hour Urine Protein Quantification
Absolute change and ratio from baseline in 24-hour urine protein (g/d) at each visit.
Time frame: Baseline, Months 1, 2, 3, 4, 5, and 6
Change from Baseline in Estimated Glomerular Filtration Rate
Change from baseline in estimated glomerular filtration rate (eGFR, mL/min/1.73 m²) at each visit.
Time frame: Baseline, Months 1, 2, 3, 4, 5, and 6
Incidence of Adverse Events During the Treatment Period
Proportion of patients experiencing at least one adverse event, serious adverse event, or adverse event of special interest (e.g., infusion/injection reactions, infections, new-onset hypertension/diabetes). Assessed based on abnormal findings in physical exams, vital signs, and laboratory tests (complete blood count, biochemistry, urinalysis).
Time frame: From first dose until 30 days after the last dose or the Month 6 visit, whichever is later
Plan to share: Yes — This study will share de-identified Individual Participant Data (IPD) to support further research. Shared datasets include: 1. Demographics \& Baseline: Age, sex, SLE/LN duration, renal biopsy type (Ⅲ/Ⅳ±Ⅴ), baseline medication, SELENA-SLEDAI score. 2. Efficacy: 24h-proteinuria, eGFR, serum creatinine at baseline and months 1-6. 3. Safety \& Immunology: ds-DNA, C3, C4; blood counts; liver/kidney function; all AEs/SAEs. 4. Treatment \& Outcomes: Randomization, drug exposure (dose/duration), time to CRR/PRR, treatment failure or withdrawal. All data will be de-identified per HIPAA/GDPR, removing direct (name, ID) and indirect identifiers to prevent re-identification.
Supporting information: Study protocol, Informed consent form
Time frame: IPD and supporting information will become available for sharing after the primary results of this study are officially published (expected no later than June 2028). The data will be accessible for at least 5 years thereafter (i.e., until June 2033) to provide the research community with sufficient time for secondary analyses and validation. The access period may be extended according to the policies of the data hosting platform or the terms of the Data Use Agreement. The specific start date will be updated in this plan and on the clinical trial registration platform concurrently with the publication of the primary paper.
Access criteria: Access is open to researchers from academic or non-profit institutions for legitimate academic purposes. For-profit entities may apply for non-commercial use, subject to data protection regulations. Approved researchers will access the de-identified IPD dataset (see Plan Description) and supporting documents (Study Protocol, SAP, ICF). Access is read-only; downloading or redistributing raw data is prohibited. Access is controlled via formal application, including: a detailed research proposal (scientific value, objectives, methods), ethical approval or waiver, and a signed Data Use Agreement (DUA). The DUA prohibits re-identification, restricts use to approved analyses, and requires proper citation of the original study. Applications are reviewed by the Principal Investigator or institutional Data Access Committee. Approved users will access data through a secure, encrypted platform.
Data sharing details ↗ · www.njrcnkd.com
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Studies of the drugs tested here: Belimumab · Telitacicept · Mycophenolic Acid
Nanjing University School of Medicine