Paricalcitol for the Treatment of Immunoglobulin A Nephropathy - A Randomized Cross-Over Study
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- change in the degree of proteinuria
研究概览
简要总结
Immunoglobulin A (IgA) nephropathy is the common type of primary glomerulonephritis in the world. A wealth of literature suggests that vitamin D and its analogs have profound effects on immune system function and glomerular mesangial cell proliferation. However, calcitriol, the standard form of vitamin D, carries a substantial risk of hypercalcemia. Recently, paricalcitol (19-nor-1,25-dihydroxyvitamin D2) was approved for the treatment of secondary hyperparathyroidism in chronic renal failure, and the incidence of hypercalcemia is much lower than calcitriol. Therefore, the investigators plan to conduct a randomized cross-over study to evaluate the efficacy of paricalcitol in the treatment of IgA nephropathy. Thirty patients with biopsy-proven IgA nephropathy will be recruited. They will be randomized to paricalcitol for 12 weeks or no treatment, followed by cross over to the other arm after a washout period. Proteinuria, renal function, serum and urinary inflammatory markers will be monitored. This study will explore the potential anti-proteinuric and anti-inflammatory effects of paricalcitol in the treatment of IgA nephropathy, which has no specific treatment at present.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
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
- •biopsy-confirmed IgA nephropathy
- •proteinuria > 1 g/day (or proteinuria > 1 g/g-Cr) in 3 consecutive samples within 12 weeks despite ACE inhibitor or angiotensin receptor blocker treatment (e.g. ramipril 5 mg daily, lisinopril 10 mg daily, or valsartan 80 mg daily) for at least 3 months
- •estimated glomerular filtration rate > 60 ml/min/1.73m2
- •corrected serum calcium level > or = 2.45 mmol/l
- •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
- •Participation in any previous trial on paricalcitol
- •Patients receiving treatment of vitamin D and/or its analogue for other medical reasons within the past 3 months
- •Patients receiving treatment of corticosteroid
- •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 paricalcitol or other vitamin D analogs
研究组 & 干预措施
1
paricalcitol 1 mg/day for 12 weeks, followed by a washout period of 4 weeks, then crossed over to no treatment for another 12 weeks
干预措施: paricalcitol (Drug)
2
no treatment for 12 weeks, followed by a washout period of 4 weeks, then crossed over to paricalcitol for another 12 weeks
干预措施: paricalcitol (Drug)
结局指标
主要结局
change in the degree of proteinuria
时间窗: 12 weeks
次要结局
- rate of decline of estimated GFR (as determined by the least square method) and change in other serum inflammatory markers(12 weeks)