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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age6-18
SponsorPeking Union Medical College Hospital

About this 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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • High-dose prednisone
  • Low-dose prednisone

Treatment groups

198 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Peking Union Medical College Hospital

Lead sponsor

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