Effect of High-dose Glucocorticoids on Markers of Inflammation and Bone Metabolism in Patients With Primary Glomerular Disease
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- the change of plasma FGF-23 level after glucocorticoids administration
研究概览
简要总结
The aim of the study is to assess the influence of high doses of intravenous corticosteroids on plasma inflammation and bone markers in patients with primary glomerular disease. The study would include 40 patients with chronic kidney disease. The main inclusion criterion is clinical and histopathological diagnosis of primary glomerular disease and urine protein excretion >2.0 g/24h. The exclusion criteria include secondary glomerular disease, acute kidney injury, acute or chronic inflammation, history of non-compliance.
详细描述
Glucocorticoids are one of the most widely used classes of drugs to treat inflammatory and autoimmune diseases. They increase formation of osteoclasts and enhance bone resorption thereby increasing risk of bone fractures and osteoporosis.
Sirtuin-1(SIRT-1) belongs to family of proteins involved in protection against inflammation and oxidative stress. A role of SIRT-1 in regulation of bone metabolism during high-dose steroid therapy is unknown.
The study protocol was approved by the local Bioethics Committee and the study is conducted according to the Declaration of Helsinki. Adult patients with the previous diagnosed primary glomerular disease based on both clinical and renal biopsy findings are included.
Plasma concentration of SIRT-1, interleukin-6 (IL-6), fibroblast growth factor 23 (FGF-23), sclerostin, calcium, phosphate, parathormone (PTH) and urine excretion of total protein, albumin, creatinine, calcium and phosphate are measured at baseline. Then the patients receive three intravenous pulses of methylprednisolone of 500 mg followed by oral prednisone 0.8-1.0 mg/kg/24h. The same measurements are repeated 4, 7 and 30 days after starting the steroid treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •previous diagnosed primary glomerular disease based on both clinical and renal biopsy findings
- •an estimated glomerular filtration rate ≥15 ml/min/1.73m2
- •proteinuria ≥2.0 g/24h
排除标准
- •secondary glomerular disease
- •acute kidney injury
- •acute or chronic inflammation
- •malignancy
- •uncontrolled hypertension with systolic blood pressure higher than 160 mmHg
- •symptomatic hypotension
- •advanced heart failure
- •history of non-compliance, dementia or depression
研究组 & 干预措施
Study population
Plasma levels of SIRT-1, IL-6, FGF-23, sclerostin, calcium, phosphate, PTH and urine excretion of total protein, albumin, creatinine, calcium and phosphate are measured at baseline. Then the patients receive three intravenous daily pulses of methylprednisolone of 500 mg followed by oral prednisone 0.8-1.0 mg/kg/24h. The same measurements are repeated 4, 7 and 30 days after starting the steroid treatment.
干预措施: Methylprednisolone, prednisone (Drug)
结局指标
主要结局
the change of plasma FGF-23 level after glucocorticoids administration
时间窗: 30 days
the change of plasma phosphate level after glucocorticoids administration
时间窗: 30 days
the change of plasma SIRT-1 level after glucocorticoids administration
时间窗: 30 days
the change of plasma PTH level after glucocorticoids administration
时间窗: 30 days
the change of urine albumin/creatinine ratio after glucocorticoids administration
时间窗: 30 days
the change of urine phosphate/creatinine ratio after glucocorticoids administration
时间窗: 30 days
the change of plasma IL-6 level after glucocorticoids administration
时间窗: 30 days
the change of urine total protein/creatinine ratio after glucocorticoids administration
时间窗: 30 days
the change of plasma sclerostin level after glucocorticoids administration
时间窗: 30 days
the change of urine calcium/creatinine ratio after glucocorticoids administration
时间窗: 30 days
the change of plasma total calcium level after glucocorticoids administration
时间窗: 30 days
次要结局
未报告次要终点
研究者
Michal Nowicki
Professor
Medical University of Lodz