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Steroid plus mycophenolate mofetil versus steroid plus cyclophosphamide for induction of lupus nephritis in children: a multicenter randomized controlled trial

Steroid plus mycophenolate mofetil versus steroid plus cyclophosphamide for induction of lupus nephritis in children: a multicenter randomized controlled trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100053545
Enrollment
Unknown
Registered
2021-11-24
Start date
2021-12-01
Completion date
Unknown
Last updated
2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lupus Nephritis

Interventions

Corticosteroids + CTX group:Corticosteroids + cyclophosphamide
Corticosteroids + MMF group:Corticosteroids + mycophenolate mofetil

Sponsors

The First Affiliated Hospital of Sun Yat-Sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
5 Years to 18 Years

Inclusion criteria

Inclusion criteria: 1. Aged 5-18 years; 2. Meet the 1997 American Rheumatology Association diagnostic criteria for systemic lupus erythematosus; 3. 24-hour urine protein quantification > 1g; 4. Renal biopsy was performed within 6 months before enrollment, according to the pathological classification criteria of lupus nephritis jointly revised by the International Society of Nephrology and the Society of Renal Pathology in 2003, the patients were diagnosed as type III, type III+V, type IV, type IV+V.

Exclusion criteria

Exclusion criteria: 1. Estimated glomerular filtration rate < 30ml/min·1.73m^2; 2. Lupus encephalopathy; 3. Severe cardiopulmonary insufficiency; 4. Suffered from pancreatitis or gastrointestinal bleeding within 3 months before enrollment; 5. Active gastric ulcer within 3 months before enrollment; 6. Regular use of immunosuppressive agents within 3 months before enrollment; 7. There are contraindications to mycophenolate mofetil, cyclophosphamide or hormones; 8. Allergy to mycophenolate mofetil, cyclophosphamide or hormones; 9. Other conditions deemed inappropriate by the investigator.

Design outcomes

Primary

MeasureTime frame
6-month complete remission rate;

Secondary

MeasureTime frame
6-month partial response rate;Time to remission;Adverse event rate;Systemic Lupus Erythematosus Disease Activity Index;

Countries

China

Contacts

Public ContactJiang Xiaoyun

The First Affiliated Hospital of Sun Yat-Sen University

jxiaoy@mail.sysu.edu.cn+86 13925038920

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026