Enteric coat mycophenolate sodium versus intravenous cyclophosphamide for severe paediatric lupus nephritis: a multicentre randomised controlled trial

Thailand Clinical Research Collaboration Network (CRCN)0 个研究点目标入组 120 人开始时间: 2009年7月29日最近更新: 2015年1月13日

适应症

试验速览

暂无简介。

•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

•1. Renal histopathology showed crescent more than 50% of total glomeruli
•2. Previously received immunoglobulins
•3. Previously undertaken plasmapheresis
•4. Peviously received mycophenolate
•5. Previously received intravenous cyclophosphamide
•6. Unable to swallow the tablets
•7. Known to have serious illness, i.e., cancer, serious infection before entry to the trial

发起方

Thailand Clinical Research Collaboration Network (CRCN)