Comparison of Slow Tapering vs Maintenance Low-dose Steroid Regimens in the Management of T Cell-Mediated Rejection in Renal Transplant Recipients: Impact on Allograft Function and Urinary Biomarkers
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Comparsion of Change in serum creatinine from baseline to 1 week, 1 month, and 3 months in the two group
研究概览
简要总结
This is prospective,open label,Randomized controlled trial comparing two steroid regimen in biopsy proven T cell mediated rejection among renal transplant recipients. sixty participients will be randomized equally to recieve either a slow tapering or maintenance low dose steroid regimen following standard pulse thearpy . The primary outcome will be the change in serum creatinine from baseline to 3 months. secondary outcomes will inculde changes in urinary biomarkers and steroid related adverse events between two groups
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Comparsion of Change in serum creatinine from baseline to 1 week, 1 month, and 3 months in the two group.
排除标准
- •Changes in urinary biomarkers from baseline to 3 months Comparison of adverse events between groups.
结局指标
主要结局
Comparsion of Change in serum creatinine from baseline to 1 week, 1 month, and 3 months in the two group
时间窗: baseline at 1 week, 1 month, and 3 months in the two group
次要结局
- Changes in urinary biomarkers from baseline to 3 months(Comparison of adverse events between groups)
研究者
Dr SANTHOSHKUMAR G
Departement of Nephrology,Postgraduate Institue of Medical Education and Research(PGIMER)