Childhood-onset Lupus Nephritis Initial Glucocorticoid-dose Harmonization Trial (LIGHT Trial)

NCT07719140 | Recruiting Phase 4

• 2 other identifiers: K104052025-PUMCH-C-047
• Study Type: interventional
• Target: 198
• Locations: 1 country
• Sites: 8

Brief Summary

Childhood-onset systemic lupus erythematosus (cSLE) is a severe chronic autoimmune disease with a high burden of major-organ involvement. Lupus nephritis (LN) affects more than half of children with SLE, and proliferative LN-including class III, IV, III+V, and IV+V disease-is associated with acute kidney injury, progression to end-stage kidney disease, and poor long-term outcomes. Glucocorticoids remain a cornerstone of induction therapy for proliferative LN. However, the optimal initial dose in children is uncertain. Although recent adult SLE and LN guidelines increasingly recommend lower-dose glucocorticoid regimens with rapid tapering, pediatric guidelines still commonly recommend high initial prednisone doses of 1.5-2.0 mg/kg/day. Adult trials and comparative observational studies suggest that lower-dose glucocorticoid regimens may preserve efficacy while reducing treatment-related toxicity. Because cumulative glucocorticoid exposure in children may impair growth, development, psychosocial well-being, and medication adherence, this trial will compare low-dose versus high-dose initial glucocorticoid regimens for induction treatment of pediatric proliferative LN. The objective is to determine whether a lower-dose regimen is non-inferior in efficacy while reducing glucocorticoid-related adverse effects and improving quality of life.

Conditions

Childhood-onset Systemic Lupus Erythematosus; Lupus Nephritis (LN)

Keywords

Children; Systemic lupus erythematosus; Lupus nephritis; Glucocorticoid; Therapy

Outcome Measures

Primary Outcomes (1)

• Total Renal Response at Week 24

  Total renal response (TRR) is defined as achievement of complete renal response (CRR), primary efficacy renal response (PERR), or partial renal response (PRR). Complete renal response (CRR) is defined as meeting both of the following criteria: 1. Proteinuria \<0.5 g/1.73 m², or 24-hour urinary protein excretion \<300 mg/m², or urine protein-to-creatinine ratio (UPCR) \<0.5 g/g; and 2. Estimated glomerular filtration rate (eGFR) within the normal range, or eGFR ≥85% of baseline, or a normal serum creatinine level with an increase of no more than 25% from baseline. Primary efficacy renal response (PERR) is defined as meeting both of the following criteria: 1. UPCR \<0.7 g/g; and 2. eGFR ≥80% of baseline or eGFR ≥60 mL/min/1.73 m². Partial renal response (PRR) is defined as meeting both of the following criteria: 1. A ≥50% reduction in proteinuria from baseline and UPCR \<3 g/g; and 2. eGFR ≥85% of baseline.

  Week 24

Secondary Outcomes (35)

• Complete Renal Response at Week 12 and 24

  Week 12, 24

• Primary Efficacy Renal Response at Week 12 and 24

  Week 12, 24

• Partial Renal Response at Week 12 and 24

  Week 12, 24

• Time to TRR

  Week 0-24

• Time to CRR

  Week 0-24

Study Arms (2)

Control group (High-dose group)

ACTIVE COMPARATOR

Standard high-dose glucocorticoid therapy

Drug: High-dose prednisone

Intervention group (Low-dose group)

EXPERIMENTAL

Low-dose glucocorticoid therapy

Drug: Low-dose prednisone

Interventions

Low-dose prednisone DRUG

All participants will receive two courses of intravenous methylprednisolone pulse therapy (10-30 mg/kg/day for 3 consecutive days per course; maximum 500 mg/day). Participants will then be randomized in a 1:1 ratio to the two treatment groups. Participants in the intervention group will receive oral prednisone at an initial dose of 0.6-0.8 mg/kg/day, with a maximum dose of 30 mg/day, followed by gradual tapering according to the predefined schedule. For participants weighing \<40 kg, doses will be adjusted in proportion to body weight using the following formula: Individual dose = standard dose × body weight (kg) × 0.025. The estimated cumulative prednisone dose over 24 weeks will be approximately 50% of that in the control group. All participants will receive background therapy with oral hydroxychloroquine, mycophenolate mofetil, and intravenous belimumab at standard doses.

Intervention group (Low-dose group)

High-dose prednisone DRUG

All participants will receive two courses of intravenous methylprednisolone pulse therapy (10-30 mg/kg/day for 3 consecutive days per course; maximum 500 mg/day). Participants will then be randomized in a 1:1 ratio to the two treatment groups. In the standard-dose (control) group, oral prednisone will be initiated at 1.4-1.6 mg/kg/day (maximum 60 mg/day), followed by gradual tapering according to the predefined schedule. For participants weighing \<40 kg, doses will be adjusted in proportion to body weight using the following formula: Individual dose = standard dose × body weight (kg) × 0.025. All participants will receive background therapy with oral hydroxychloroquine, mycophenolate mofetil, and intravenous belimumab at standard doses.

Control group (High-dose group)

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age ≥6 years and \<18 years, with body weight ≥20 kg
• Meets the 2019 European League Against Rheumatism (EULAR) and American College of Rheumatology (ACR) classification criteria for Systemic Lupus Erythematosus (SLE)
• Renal biopsy confirming Lupus Nephritis class III, IV, III+V, or IV+V according to the International Society of Nephrology / Renal Pathology Society (ISN/RPS) classification
• At screening: 24-hour urinary protein ≥1.0 g (or ≥25 mg/kg), or urine protein-to-creatinine ratio (UPCR) ≥1.0 g/g
• White blood cell count ≥3.0 × 10⁹/L and lymphocyte count ≥1.0 × 10⁹/L
• No prior intravenous methylprednisolone pulse therapy before enrollment, and glucocorticoid exposure ≤2 weeks before enrollment, with a maximum prednisone-equivalent dose ≤30 mg/day (or ≤1 mg/kg/day)
• Written informed consent obtained and good treatment compliance expected

You may not qualify if:

• Uncertain diagnosis of SLE, genetically confirmed monogenic lupus, or a history of immunodeficiency
• Severe infection, including hepatitis C, active hepatitis B, HIV infection, tuberculosis infection, severe fungal infection, etc.
• Severe neuropsychiatric lupus
• Peripheral blood hemoglobin \<60 g/L, platelet count \<10 × 10⁹/L, or concomitant aplastic anemia
• Severe cardiac insufficiency (NYHA functional class ≥ II)
• Severe pulmonary involvement, including pulmonary hemorrhage, respiratory failure, pulmonary embolism, or other conditions requiring respiratory support
• Estimated glomerular filtration rate (eGFR) \<60 mL/min/1.73 m²
• Severe gastrointestinal bleeding, pancreatitis, or hepatic lesions
• Patients deemed by the investigator to be unsuitable for participation in this trial

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead
• Children's Hospital of Chongqing Medical University: collaborator
• Beijing Children's Hospital: collaborator
• Second Xiangya Hospital of Central South University: collaborator
• Shenzhen Children's Hospital: collaborator
• Nanjing Children's Hospital: collaborator
• Jilin University: collaborator
• Children's Hospital of Fudan University: collaborator

Study Sites (8)

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100730, China

RECRUITING

Beijing Children's Hospital, Capital Medical University

Beijing, Beijing Municipality, China

RECRUITING

Chidren's Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

NOT YET RECRUITING

Shenzhen Children's Hospital

Shenzhen, Guangdong, China

NOT YET RECRUITING

The Second Xiangya Hospital of Central South University

Changsha, Hunan, China

NOT YET RECRUITING

Children's Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

NOT YET RECRUITING

Jilin University

Changchun, Jilin, China

NOT YET RECRUITING

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, China

NOT YET RECRUITING

Related Publications (19)

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MeSH Terms

Conditions

Lupus Nephritis; Lupus Erythematosus, Systemic

Interventions

Prednisone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Hongmei Song, MD, PhD

  Peking Union Medical College

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sihao Gao, MD, PhD

CONTACT

86-10-69155727; sihao.gao@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 13, 2026
• First Posted: July 22, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): March 1, 2029
• Last Updated: July 22, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (8)