A prospective, randomized, multicenter, open-label, parallel-arm Study to compare effectiveness of mycophenolate mofetil versus cyclophosphamide in the Induction Therapy of pediatric patients with Active Proliferative Lupus Nephritis in Chinese population
Scattered research in adults showed that both mycophenolate mofetil (MMF) and cyclophosphamide (CYC) can be used in the induction therapy of lupus nephritis. however data is limited in children.Therefore, the purpose of this study is to observe and compare the efficacy and safety of MMF and CYC as induction therapy for children with proliferative lupus nephritis through a multi-center open randomized controlled study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
224
The patients will be divided into two groups randomly. Cyclophosphamide for injection, 750mg/m2 each time, 1g at most, once a month for 6 consecutive months. Steroids : intravenous methylprednisolone, 15\~30mg/kg · day, maximum 1000mg/day, 3 consecutive days a week for 2 weeks; during the interval of methylprednisolone pulse therapy and after:prednisone tablets 2mg/kg · day with a maximum dose 60mg / day. The duration of induction therapy: 6 months.
The patients will be divided into two groups randomly. Mycophenolate mofetil, tablets, 30-40mg/ (kg · day), BID, the maximum amount is no more than 2g/d. Steroids : intravenous methylprednisolone, 15\~30mg/kg · day, maximum 1000mg/day, 3 consecutive days a week for 2 weeks; during the interval of methylprednisolone pulse therapy and after:prednisone tablets 2mg/kg · day with a maximum dose 60mg / day. The duration of induction therapy: 6 months.
the Second Xiangya Hospital of Central South University
Changsha, Hunan, China
RECRUITINGEffective rate of LN treatment
complete remission and partial remission
Time frame: 6 months
complete remission time
complete remission time within 6 months of designed induction therapy
Time frame: 6 months
Incidence of LN treatment failure
occurrence of end stage renal disease or serum creatinine reached twice the baseline or 24 urinary protein or urinary protein / creatinine reached twice the baseline at 6 months of follow-up.
Time frame: 6 months
Incidence of creatinine doubling
serum creatinine reaching 2 times of the baseline level
Time frame: 6 months
LN recurrence rate
(1) proteinuria recurrence, which is defined as continuous proteinuria ≥ 1.0 g/d (or 25mg/kg) after complete remission (CR) or increase ≥ 2.0 g/d (or 50mg/d) after partial remission (PR), with or without hematuria; (2) The increase of Scr level is defined as the increase of Scr level ≥ 50% when the baseline examination is normal, or 30% when the baseline examination is abnormal.
Time frame: 6 months
SLE recurrence rate
new onset of skin erythema, vasculitis, joint pain, hematological diseases (platelet \<50\*109/l or hemolytic anemia), neurological symptoms, lupus myocarditis, lupus pneumonia, serous cavity inflammation or new abnormalities in laboratory examination (antibodies, C3 and C4), and SLEDAI score greater than or equal to 4 points.
Time frame: 6 months
SLE disease activity score
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Systemic Lupus Erythematosus Disease Activity Index 2000 score at 6 months
Time frame: 6 months
partial remission time
Partial remission time within 6 months of designed
Time frame: 6 months