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

Recruiting now · Phase 4

Conditions studied: Childhood-onset Systemic Lupus Erythematosus, Lupus Nephritis (LN)

In brief

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.

Key facts

Study ID

NCT07719140

Run by

Peking Union Medical College Hospital

People needed

198

Starts

2026-07-01

Expected to finish

2029-03-01

Last updated by the study team

2026-07-22

Who can join

Age: 6 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Peking Union Medical College Hospital, Chinese Academy of Medical Sciences — Beijing, Beijing Municipality, China (enrolling)
• Beijing Children's Hospital, Capital Medical University — Beijing, Beijing Municipality, China (enrolling)
• Chidren's Hospital of Chongqing Medical University — Chongqing, Chongqing Municipality, China
• Shenzhen Children's Hospital — Shenzhen, Guangdong, China
• The Second Xiangya Hospital of Central South University — Changsha, Hunan, China
• Children's Hospital of Nanjing Medical University — Nanjing, Jiangsu, China
• Jilin University — Changchun, Jilin, China
• Children's Hospital of Fudan University — Shanghai, Shanghai Municipality, China

Full record on ClinicalTrials.gov

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