The effect of calcitriol on progress and activity of Lupus nephritis

Vice- Chancellorship for Research, Guilan University of Medical Sciences, Iran0 个研究点目标入组 50 人开始时间: 待定最近更新: 2018年2月22日

适应症

试验速览

暂无简介。

•Inclusion Criteria:
•aged 18-65 years; baseline SLEDAI 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;

•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

发起方

Vice- Chancellorship for Research, Guilan University of Medical Sciences, Iran