CTRI/2024/04/065664尚未招募4 期
A Real world, Prospective, Observational Multicenter Study to Monitor the Routine Clinical Use of Pegylated Erythropoetin (PegEPO) in the Treatment of Anemia due to Chronic Kidney Disease.
Dr. Sanjay Srinivas2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年4月19日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- To monitor the routine clinical use of PegEPO in Indian CKD patients and to assess the real-world efficacy and safety of PegEPO among Indian patients suffering from anemia due to CKD.
研究概览
简要总结
This real world, prospective, multicenter, observational study is being conducted to monitor the routine clinical use of PegEPO in Indian CKD patients.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •(1.) Adult male or female patients, diagnosed with CKD stage IV-V (Non-Dialysis) or on Maintenance Haemodialysis (greater or equal to 3 months) and who require treatment with PegEPO will be enrolled.
- •(2.) Patients on rEPO/ DPO with stable dosing for 3 months.
- •(3.) Hb- 7 to 10g/dl.
- •(4.) Patients should be iron replenished and not be suffering from iron deficiency.
- •(5.) Patients willing to provide informed consent.
- •(6.) Patients receiving PegEPO as part of routine clinical practice.
排除标准
- •(1.) Any patient who does not fit the inclusion criteria as per physicians opinion or not fit for PegEPO therapy as per PI.
- •(2.) Patient with a history of hypersensitivity reactions or contraindication to the excipients of Peg EPO.
结局指标
主要结局
To monitor the routine clinical use of PegEPO in Indian CKD patients and to assess the real-world efficacy and safety of PegEPO among Indian patients suffering from anemia due to CKD.
时间窗: Time to increase in Hb by 1gm percent from baseline.
次要结局
- To assess the safety of PegEPO in CKD patients.(From baseline to 1 month, 3 month and 6 months.)
研究者
Dr Sanjay Srinivas
Dr. Sanjays Center For Kidney and Diabetes
研究点 (2)
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