Initial glucocorticoid-dose harmonization in childhood lupus nephritis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional trial enrolls children aged 6 to under 18 with systemic lupus erythematosus and biopsy-proven lupus nephritis classes III, IV, III+V, or IV+V. It compares high-dose versus low-dose initial prednisone during induction therapy, aiming to see if lower starting doses can maintain efficacy while reducing toxicity. Participants are required to have active kidney involvement and meet specific laboratory and prior treatment criteria. The study is conducted at several major Chinese pediatric and adult-capacity centers with established expertise in lupus care. Outcomes of interest include kidney response, growth and development, and adverse events related to glucocorticoids.

Why it matters

Who can join: the full rules

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

Where it's running

• Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
  Beijing, Beijing Municipality, China Recruiting
• Beijing Children's Hospital, Capital Medical University
  Beijing, Beijing Municipality, China Recruiting
• Chidren's Hospital of Chongqing Medical University
  Chongqing, Chongqing Municipality, China Not yet recruiting
• Shenzhen Children's Hospital
  Shenzhen, Guangdong, China Not yet recruiting
• The Second Xiangya Hospital of Central South University
  Changsha, Hunan, China Not yet recruiting
• Children's Hospital of Nanjing Medical University
  Nanjing, Jiangsu, China Not yet recruiting

Study contacts

• Principal investigator: Hongmei Song, MD, PhD — Peking Union Medical College
• Study coordinator: Sihao Gao, MD, PhD
• Email: sihao.gao@gmail.com
• Phone: 86-10-69155727

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• CD19 CAR-T Therapy for Kids with Refractory Childhood SLE

  This study tests whether a patient’s own CD19 CAR-T cells can help children and young adults with severe, hard-to-treat lupus.

  Recruiting Phase 1 Seoul National University Hospital · Seoul · NCT07855302

• TranspoCART19 CAR-T therapy in adults with refractory lupus nephritis

  This trial tests whether a patient’s own CD19 CAR-T cells can be safely given and potentially help adults with lupus nephritis that isn’t responding to standard treatments.

  Recruiting Phase 1/2 Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz · Badalona, Barcelona and 7 other locations · NCT07799116

• Lupus Nephritis Care Pathway

  A small group of adults with lupus nephritis will try a team-based care path that uses telemedicine and pharmacist-led support to help manage their treatment and see if it improves adherence and outcomes.

  Recruiting Duke University · Durham, North Carolina · NCT07783152

• See if empagliflozin helps kidney function in people with lupus nephritis

  This study tests whether adding empagliflozin to standard care improves kidney function in adults with active lupus nephritis.

  Recruiting Phase 4 Beni-Suef University · Banī Suwayf · NCT07700940

• HB2198 for adults with moderate to severe lupus, including lupus nephritis and extra‑renal lupus

  This trial will test whether two intravenous doses of HB2198 can safely reduce B cells and improve disease measures in adults with moderate to severe lupus, including lupus nephritis and extra‑renal lupus.

  Recruiting Phase 1 Hinge Bio · Brisbane · NCT07491900

• HSK39297 tablets for lupus nephritis

  This trial will test whether once-daily oral HSK39297 (200 mg or 300 mg) is safe and well tolerated compared with placebo in adults with active lupus nephritis.

  Recruiting Phase 2 Haisco Pharmaceutical Group Co., Ltd. · Nanjing, Jiangsu · NCT07363460

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.