Comparison Between Mycophenolate andCyclophosphamide in the Treatment of Lupus Nephritis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- • Erythrocyte sedimentation rate.(ESR)
研究概览
简要总结
The aim of this work is to study the effect and side effects of the cyclophosphamide versus mycophenolate in lupus nephritis
详细描述
Systemic lupus erythematosus (SLE), also known simply as lupus, is an autoimmune disease in which the body's immune system mistakenly attacks healthy tissue in many parts of the body.
Symptoms vary between people and may be mild to severe. common symptoms include painful and swollen joints, fever, chest pain, hair loss, mouth ulcers, swollen lymph nodes, feeling tired, and a red rash which is most commonly on the face. Often there are periods of illness, called flares, and periods of remission during which there are few symptoms.painless passage of blood or protein in the urine may often be the only presenting sign of kidney involvement.
Acute or chronic renal impairment may develop with lupus nephritis, leading to acute or end-stage kidney failure. Because of early recognition and management of SLE, end-stage renal failure occurs in less than 5% of cases; except in the black population, where the risk is many times.Nephritis is the most severe manifestation of lupus. Between 1950s and 1970s, corticosteroids were used for the treatment of lupus nephritis (LN) ,and using of cyclophosphamide(CPM), improved the outcome dramatically with 5 years survival increasing from 17% to 80%.Subsequently, intravenous (iv) CPM became the standard of care in induction regimes; however, ivCPM was associated with complications such as bladder toxicity, gonadal problems, and infections. To reduce the toxicity, low-dose of 500mg iv(CPM) every two weeks for six months showed equivalent efficacy and less side effect.
Mycophenolatemofetil(MMF) is widely used in solid organ transplantation and it reduces the rate of acute rejection following renal transplantation.
It has also been used to treat patients with other immune-mediated disorders such as immunoglobulin A nephropathy, small-vessel vasculitides and psoriasis .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •All patients have systemic lupus erythromatosis with lupus nephritis either newly diagnosed or with history of SLE with lupus nephrits
- •All stage of lupus nephritis except stage(i,v,vi)
- •patients who accepted to participate in the study.
排除标准
- •Patient with acute inflammatory process such as(rheumatoid arthritis or other rhumatoligical diseases).
- •Patients who are taking other immunosuppressive therapy.
- •Patients with malignancies.
- •Patients with HCV, HBV or HIV infection.
- •Patients with lupus nephritis sage(i,v,vi).
研究组 & 干预措施
cyclophosphamide
participants will receive intra venous cyclophosphamide 500mg once every two weeks for 6months.
干预措施: cyclo phosphamide (Drug)
mycophenolate
participants will receive oral mycophenolat 2 to 3mg/kg for 6 months.
干预措施: mycophenolate (Drug)
结局指标
主要结局
• Erythrocyte sedimentation rate.(ESR)
时间窗: 6 months.
can help us to determine if patients have inflammation.These investigation will be done before starting the pharmacotherapy and after the end of the therapy .its range from (15to10mm/hr)its level increase in lupus.
serume creatinine (sCR)
时间窗: 6 months
to measure treatment response and determine renal function These investigation will be done before starting the pharmacotherapy and after the end of the therapy.its normal range from(0.4 to1.5 mg/dl)its level increase in lupus.
blood uerea nitrogen.
时间窗: 6 months
to measure treatment response and determine renal function These investigation will be done before starting the pharmacotherapy and after the end of the therapy.its normal range ,around7to20mg/dl(2.5to7.1mmol) its level increase in lupus.
• complete blood count.(CBC)( red blood cells,white blood cells,platelets)
时间窗: 6 months
to know all information about red blood cells,white blood cells,platelets and effect of two drus on it.These investigation will be done before starting the pharmacotherapy and after the end of the therapy at six months.
• Complement 3 (C3)
时间窗: 6 months
will done for diagnosis and ascertain activity of lupus These investigation will be done before starting the pharmacotherapy and after the end of the therapy .c3range from75to175mg/lcomplementc3 level are lower in lupus.
• Anti ds DNA
时间窗: 6 months
will done for diagnosis and ascertain activity of lupusThese investigation will be done before starting the pharmacotherapy and after the end of the therapy if the antidsDNA level are high the lupus may be active and if its level is low the lupus is less active.its rangr(\<18iu/ml)
• 24h urine test for creatinine clearance and protien excretion.
时间窗: 6 months.
the test is used to check kideny function.•These investigation will be done before starting the pharmacotherapy and after the end of the therapy.normal urinary protie-to-creatinine ratio is\<0.2.
次要结局
未报告次要终点
研究者
suzan.D.zakaria
principal investigator
Al-Azhar University