The Safety and Short-Term Efficacy of Calcitriol in the Treatment of Immunoglobulin A Nephropathy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Primary end point of the study is the change in the degree of proteinuria.
研究概览
简要总结
Immunoglobulin A (IgA) nephropathy is the most 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. Calcitriol, an active form of vitamin D, is commonly used for the treatment of secondary hyperparathyroidism in patients with advanced chronic kidney diseases. Therefore, the investigators plan to conduct a open-label single-arm study to evaluate the safety and efficacy of calcitriol in the treatment of IgA nephropathy. Ten patients with biopsy-proven IgA nephropathy and persistent proteinuria despite conventional therapy will be recruited. They will be treated with calcitriol for 12 weeks. Proteinuria, renal function, serum and urinary inflammatory markers will be monitored. This study will explore the potential anti-proteinuric and anti-inflammatory effects of calcitriol in the treatment of IgA nephropathy, which is a major cause of dialysis-dependent renal failure.
详细描述
This is a open-label and single arm study. We plan to recruit 10 patients with biopsy-proven IgA nephropathy will be recruited.
Treatment regimen and dosage adjustment
At week 0, all patients will receive calcitriol (oral capsule) at a fixed dose of 0.5 mcg twice weekly. If there is no adverse effect and corrected serum calcium remains < 2.55 mmol/l, the dose of calcitriol will be maintained for 12 weeks.
If corrected serum calcium is 2.55 to 2.62 mmol/l, the dose of calcitriol will be reduced to 0.25 mcg twice weekly. Serum calcium will be rechecked after 2 weeks (or more frequently if indicated). If corrected serum calcium remains < 2.55 mmol/l, the dose of calcitriol will be maintained for the rest of the study period. If corrected serum calcium remains > 2.62 mmol/l for two consecutive measurements despite reducing the dose of calcitriol, the study medication will be stopped and the subject will be discontinued from the study.
If corrected serum calcium is > 2.75 mmol/l at any time, hold calcitriol for one week and repeat laboratory test for calcium. If the subject's next serum calcium is < 2.62 mmol/l, calcitriol may be restarted at 0.25 mcg twice weekly. If the next serum calcium level is > 2.62 mmol/l, the subject will be discontinued from the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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 2 consecutive samples within 12 weeks despite ACE inhibitor or angiotensin receptor blocker treatment (ramipril 5 mg daily, lisinopril 10 mg daily, or valsartan 80 mg daily) for at least 3 months
- •estimated glomerular filtration rate 15 to 60 ml/min/1.73m2
- •corrected serum calcium level M 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 vitamin D analogue
- •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 vitamin D analogs
结局指标
主要结局
Primary end point of the study is the change in the degree of proteinuria.
次要结局
- Secondary end points include the change in renal function and other serum inflammatory markers.