Enteric coat mycophenolate sodium versus intravenous cyclophosphamide for severe paediatric lupus nephritis

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2009
INTERVENTION: Intervention arm: Enteric coated mycophenolate sodium (myfortic®) 720 ‐ 860 mg/m^2/day via oral administration twice daily + oral steroid. Total duration of treatment: 12 months Total duration of follow‐up: 12 months Control arm: Cyclophosphamide 750 ‐ 1000 mg/m^2/day (maximum dose 1000 mg/day) via intravenous drip monthly for 6 months then every 3 months + oral steroid. Total duration of treatment: 12 months Total duration of follow‐up: 12 months CONDITION: Paediatric lupus nephritis ; Musculoskeletal Diseases ; Systemic lupus erythematosus PRIMARY OUTCOME: 1. Complete and/or partial remission at the end of month 6; 2. Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) score at the end of month 6 SECONDARY OUTCOME: 1. Rate of end‐stage renal disease (ESRD) or chronic renal failure (CRF) at month 12; 2. Death rate; 3. Infection rate; 4. Gastrointestinal (GI) side‐effect rate; 5. Rate of relapse; 6. Rate of renal relapse; 7. Dosage of concomitant steroid INCLUSION CRITERIA: 1. 7 ‐ 15 year old children (either sex) who had lupus according to American Rheumatology Association criteria (first the diagnosis time was between 7 ‐ 15 years old) 2. Renal histology revealed lupus nephritis class III or IV according to World Health Organization (WHO) classification: 2.1. Lupus nephritis class III include one of these following: 2.1.1. Nephritic range proteinuria ‐ urine protein/creatinine ratio equal or more than 2 2.1.2. Acute nephritis ‐ oedema, hypertension and haematuria 2.1.3. Renal insufficiency ‐ estimated glomerular filtration rate (eGFR) less than 90 2.2. Lupus nephritis class IV 3. Serum creatinine not more than 3 mg/dl 4. Must stop oral cyclophosphamide for at least 6 month before enter to the trial 5. Parents and child was informed and give the consent to participate the trial
Epistemonikos ID: 585dc57b51b0407ffd2c26934035ba2fb0e7e844
First added on: Aug 22, 2024