Desidustat versus Erythropoietin in Anaemia due to Chronic Kidney Disease A randomized clinical trial
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Mean change in haemoglobin (g/dL) from baseline to the evaluation period (Weeks 16–24).
研究概览
简要总结
Anaemia is a common and disabling complication in patients with chronic kidney disease (CKD). Current treatment with injectable erythropoietin requires frequent hospital visits and may cause fluctuations in haemoglobin levels and other side effects. Desidustat is a new oral medicine that increases natural erythropoietin production by stabilising hypoxia-inducible factors and may offer a simpler alternative.
This study, named DELIGHT, is a randomised, open-label clinical trial being conducted at Government Medical College and Government Superspecialty Hospital, Jammu. Adults with CKD anaemia, both on maintenance dialysis and on medical management, will be assigned in equal numbers to receive either oral desidustat tablets or injectable erythropoietin for 24 weeks. The main aim is to compare the rise in haemoglobin between the two groups. Secondary measures include the proportion achieving target haemoglobin 10–12 g/dL, time to reach target, changes in iron and lipid parameters, and safety outcomes such as blood pressure, potassium levels, and eye or kidney findings.
Results will help determine whether oral desidustat can be an effective and convenient alternative to injectable erythropoietin for Indian patients with CKD-related anaemia.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Adults more than 18 years with CKD stages 3–5 (including maintenance dialysis) and anaemia (Hb less than 10 g/dL), who have provided informed consent.
排除标准
- •Active bleeding, uncontrolled hypertension, malignancy, pregnancy or lactation, recent ESA use less than 8 weeks, severe hepatic impairment, known hypersensitivity to study drugs.
结局指标
主要结局
Mean change in haemoglobin (g/dL) from baseline to the evaluation period (Weeks 16–24).
时间窗: Weeks 16–24
次要结局
- 1. Proportion with Hb 10–12 g/dL by Week 24 2. Time to first target Hb 10–12 g/dL 3. Change in ferritin, TSAT, lipid profile, potassium 4. Incidence of adverse events (hyperkalaemia, hypertension, vascular access thrombosis, retinopathy).
研究者
Mohit Goyal
Government Medical College, Jammu