Erythropoietin versus Desidustat in Anemia due to Chronic Kidney Disease with dialysis Randomized open label active control study
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- 1.To assess the change in the hemoglobin level between desidustat and erythropoietin in patients with chronic kidney disease (CKD) undergoing dialysis
研究概览
简要总结
Anemia is a common complication of chronic kidney disease (CKD) especially at the advanced stage of disease.The cause of anemia in CKD is due to reduced erythropoietin (EPO) secretion and several other factors, the most important being alteration in the metabolism of iron, which is due to an increase in the activity of hepcidin and reduction in the clearance.The recent trend in the management of anemia in CKD patients is by using medications that stimulate the endogenous production of erythropoietin. HIF-prolyl hydroxylase enzyme inhibitors are a new class of agents for the treatment of anemia in CKD. These agents work by stabilizing the HIF complex and stimulating endogenous erythropoietin production. Desidustat is an orally bioavailable, HIF-prolyl hydroxylase (HIF-PH) inhibitor.Furthermore HIF-PHI is an emerging oral drug for the treatment of renal anemia, there is lack of studies on its long-term efficacy and safety; like its effect on renal function and the progression of disease in patients remains unknown. The present study will be carried out to compare the effectiveness and safety of desidustat and erythropoietin in anemia due to CKD.
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 70.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients of either gender aged more than 18 years clinical diagnosis of anemia due to CKD stage 5 2.Patients on dialysis more than 2 times in a week for at least 4-6 weeks prior to screening 3.Baseline hemoglobin level of 8.0–11.0 g/dL 4.Serum ferritin more than 100ng/mL and not more than 500ng/ml and/or transferrin saturation TSAT more than 20% 5.Patients who do not have deficiency of folate or vitamin B12 after the determination of serum levels 6.Patients who had not received Erythrocyte Stimulating Agents ESA EPO analog EPO naïve for at least 4 weeks prior to screening visit and prior ESA users patients on a stable dose of ESA at least 4 weeks prior to screening 7.Patients who will be on stable dose of ESA for atleast 4 weeks prior to screening more than 30percent of dose change.
排除标准
- •Uncontrolled hypertension SBP more than 200 mmHg or DBP more than 110 mmHg at screening visit before dialysis 2.Previous history of kidney transplant 3.Patients who have received blood transfusion within 8 weeks prior to screening 4.Patients with hepatitis B or C infection as per serology or Human immunodeficiency virus HIV infection.
- •5.Previous history of or currently diagnosed to have malignancy 6.Patient receiving high dose of erythropoietin at screening visit.
- •Erythropoietin of ≥450 IU/kg/week intravenous or more than 300 IU/kg/week subcutaneous 7.Patients who have undergone major surgery in the past 3 months 8.Malabsorption syndrome, resection of the small bowel or inflammatory bowel disease 9.History of bleeding disorders 10.Stroke or intracranial hemorrhage prior to enrollment 11.Had history of allergy to Desidustat or Erythropoietin 12.Pregnant and breastfeeding women.
结局指标
主要结局
1.To assess the change in the hemoglobin level between desidustat and erythropoietin in patients with chronic kidney disease (CKD) undergoing dialysis
时间窗: Baseline and week 4 8 12 16 20 24 | Week 4 12 24 26
2.To assess the adverse effects using WHO causality assessment scale
时间窗: Baseline and week 4 8 12 16 20 24 | Week 4 12 24 26
次要结局
- The number of patients with hemoglobin response(16 and 24 weeks)
研究者
Sarala N
Sri Devaraj Urs Medical College