Lower versus higher starting prednisone doses for lupus kidney disease in children
Compares low and high starting prednisone doses in children with lupus nephritis.
Plain-language title generated from the registry record
Registry title: Childhood-onset Lupus Nephritis Initial Glucocorticoid-dose Harmonization Trial (LIGHT Trial)
Key facts
- Where
- Beijing, Changchun, Changsha, Chongqing, Nanjing, Shanghai, and Shenzhen, ChinaSee the 8 sites
- Phase
- Phase 4
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 6 and 18 years old?
Source: NCT07719140, who can take part
Where in China
- Beijing Children's Hospital, Capital Medical UniversityBeijing, ChinaTaking people
- Peking Union Medical College Hospital, Chinese Academy of Medical SciencesBeijing, ChinaTaking people
- Jilin UniversityChangchun, ChinaNot yet recruiting
- The Second Xiangya Hospital of Central South UniversityChangsha, ChinaNot yet recruiting
- Chidren's Hospital of Chongqing Medical UniversityChongqing, ChinaNot yet recruiting
- Children's Hospital of Nanjing Medical UniversityNanjing, ChinaNot yet recruiting
- Children's Hospital Of Fudan UniversityShanghai, ChinaNot yet recruiting
- Shenzhen Children's HospitalShenzhen, ChinaNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Peking Union Medical College Hospital
- Trial code
- NCT07719140
- Record updated
- 22 July 2026
- Original description
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.Read full original descriptionShow less
Low- Versus High-Dose Initial Glucocorticoid Therapy for Childhood-Onset Proliferative Lupus Nephritis: a Multicenter Open-Label Noninferiority Randomized Controlled Trial
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.
Inclusion: 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: 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 cardiac insufficiency (NYHA functional class ≥ II); Severe pulmonary involvement, including pulmonary hemorrhage, respiratory failure, pulmonary embolism, or other conditions requiring respiratory support; Severe gastrointestinal bleeding, pancreatitis, or hepatic lesions; Peripheral blood hemoglobin <60 g/L, platelet count <10 × 10⁹/L, or concomitant aplastic anemia; Estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m²; Severe neuropsychiatric lupus; Patients deemed by the investigator to be unsuitable for participation in this trial.