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

RecruitingPhase 4Ages 6 Years - 18 YearsAllPeking Union Medical College Hospital
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Exclusion Criteria: * 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
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What it tests

  • High-dose prednisone
  • Low-dose prednisone
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Where

8 sites
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Beijing, China
Beijing Children's Hospital, Capital Medical University
Beijing, China
Chidren's Hospital of Chongqing Medical University
Chongqing, China
Shenzhen Children's Hospital
Shenzhen, China
The Second Xiangya Hospital of Central South University
Changsha, China
Children's Hospital of Nanjing Medical University
Nanjing, China
Jilin University
Changchun, China
Children's Hospital of Fudan University
Shanghai, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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