NCT07719140RecruitingPhase 4
Childhood-onset Lupus Nephritis Initial Glucocorticoid-dose Harmonization Trial (LIGHT Trial)
Low- Versus High-Dose Initial Glucocorticoid Therapy for Childhood-Onset Proliferative Lupus Nephritis: a Multicenter Open-Label Noninferiority Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 22 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 198 (estimated)
- First submitted
- 13 Jul 2026
- Start date
- Jul 2026
- Primary completion date
- Sept 2028
- Lead sponsor
- Peking Union Medical College Hospital
- Diseases
- Lupus (SLE)
- NCT number
- NCT07719140
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 198
- From Jul 2026 to the primary completion date, Sept 2028
- 8 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Lab values
- 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
Other
- Severe neuropsychiatric lupus
- Patients deemed by the investigator to be unsuitable for participation in this trial
Who the study is looking for
- 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
Age in the registry: 6 years to 18 years · Sex: All · Does not accept healthy volunteers
Sites (8)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking Union Medical College Hospital, Chinese Academy of Medical Sciences Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| Beijing Children's Hospital, Capital Medical University Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| Jilin University Coordinator of this site? Confirm its status | Changchun | China | Not yet recruiting |
| The Second Xiangya Hospital of Central South University Coordinator of this site? Confirm its status | Changsha | China | Not yet recruiting |
| Chidren's Hospital of Chongqing Medical University Coordinator of this site? Confirm its status | Chongqing | China | Not yet recruiting |
| Children's Hospital of Nanjing Medical University Coordinator of this site? Confirm its status | Nanjing | China | Not yet recruiting |
| Children's Hospital Of Fudan University Coordinator of this site? Confirm its status | Shanghai | China | Not yet recruiting |
| Shenzhen Children's Hospital Coordinator of this site? Confirm its status | Shenzhen | China | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.