The Effect of Calcitriol on Progress and Activity of Lupus Nephritis
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- change in proteinuria
研究概览
简要总结
The purpose of this study is to determine whether calcitriol is effective in the treatment of lupus nephritis.
详细描述
Systemic lupus erythematosus (SLE) is an autoimmune disease and renal involvement represent one of the most common manifestations of it . On the other hand, there is evidence that vitamin D and its analogs have known immunosuppressant properties and profound effects on glomerular mesangial cell proliferation. Moreover much literature such as animal studies suggests it as a therapeutic intervention in autoimmune disease. The investigators plan to conduct a double blind randomized control clinical trial to study effects of calcitriol on progress and activity of lupus nephritis. Fifty patients with clinically quiescent SLE and biopsy-proven glomerulonephritis will be recruited. They will be treated with calcitriol for 1 year. Proteinuria, renal function, lupus disease activity, serum inflammatory markers will be monitored.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18-65 years
- •Baseline Systemic Lupus Erythematosus Disease Activity Index score <= 4
- •Estimated glomerular filtration rate more than 15 ml/min/1.73m2
- •Proteinuria > 1 g/day (or proteinuria > 1 g/g-Cr) in 2 consecutive samples within 12 weeks despite ACE inhibitor at least 3 months
- •On maintenance dose of prednisolone < 15 mg/day with or without other immunosuppressive medications
- •Serum calcium level in normal range( 8.5-10.5 mg/dl)
- •History of biopsy-proven lupus nephritis clinical quiescent SLE for at least 3 month
- •Willingness to give written consent and comply with the study protocol
排除标准
- •Pregnancy, lactating or childbearing potential without effective method of birth control
- •Severe gastrointestinal disorders that interfere with their ability to receive or absorb oral medication
- •History of malignancy, including leukemia and lymphoma within the past 2 years; Systemic infection requiring therapy at study entry
- •Any other severe coexisting disease such as, but not limited to, chronic liver disease, myocardial infarction, cerebrovascular accident, malignant hypertension
- •History of drug or alcohol abuse within past 2 years
- •Vitamin D deficiency(25 hydroxy vitamin D less than 20ng/ml)
- •Participation in any previous trial on vitamin D analogue
- •Patients receiving treatment of vitamin D and/or its analogue for other medical reasons within the past 4 weeks
- •Patients who are taking multivitamin supplement that contains vitamin D could be enrolled after 4 weeks of wash out period by changing to a preparation that has no vitamin D
- •On other investigational drugs within last 30 days
- •History of a psychological illness or condition such as to interfere with the patient's ability to understand the requirement of the study
- •History of non-compliance; Known history of sensitivity or allergy to vitamin D analogs
研究组 & 干预措施
treatment group
Patients will receive calcitriol at a fixed dose daily.
干预措施: calcitriol (Drug)
control group
Patients will receive placebo daily.
干预措施: placebo (Drug)
结局指标
主要结局
change in proteinuria
时间窗: baseline and 12 months
次要结局
- risk of lupus flare(baseline and 12 months)
- change in renal function(baseline and 12 months)
- change in serum inflammatory markers(baseline and 12 months)
- change in Systemic Lupus Erythematosus Disease Activity Index score(baseline and 12 months)
研究者
Alireza Amir Maafi
Minister of Student Research Committee
Guilan University of Medical Sciences