Effect of Daprodustat and Epoetin Alpha on Anemia in Patients Not Undergoing Dialysis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Hemoglobin Levels
研究概览
简要总结
Anemia in CKD patients is mainly attributed to impaired kidney being unable to adequately respond to hypoxia and/or anaemia by inducing erythropoietin (EPO) production iron disorders, blood loss, shortened erythrocyte survival time and inflammation. High mortality among patients with advanced renal failure is directly related to the severity of anemia and hypoalbuminemia, particularly within the first six months.4, 5 Currently, the main treatment modalities for anemia in CKD include injections of erythropoiesis stimulating agents (ESAs), iron supplementation, and blood transfusion. EPO resistance and iron refractory anemia require red blood cell transfusions.
The rationale of this study is to compare the effectiveness of daprodustat versus epoetin alpha on hemoglobin level in patients with chronic kidney disease not on hemodialysis. Literature showed that epoetin alpha has better effectiveness in improving hemoglobin level and curing anemia in CKD patients. But conflicting results have been osbevred showing no difference in both drugs. In routine, both drugs are recommended for anemia in non-dialysis CKD patients. This trial is planned to check the effect of Daprodustat in patients not undergoing dialysis is primarily to provide an effective, orally administered alternative to current injectable anemia treatments, which are associated with several limitations and safety concerns. The treatment strategies and effectiveness optimization for patients with chronic kidney disease complicated by anemia remain a key issue that urgently needs to be addressed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-65 years, either gender.
- •Confirmed CKD stage 3, 4, or
- •Not currently receiving dialysis at time of screening.
- •Hemoglobin at presentation: 8.0-10 g/dL, serum ferritin > 100 ng/mL at screening and transferrin saturation (TSAT) > 20% at screening.
排除标准
- •Clinically significant gastrointestinal bleeding, major surgery or RBCs transfusion in last 4 weeks
- •Pregnant, breast-feeding, not agreed to use contraception
- •Uncontrolled hypertension (>180/100 mmHg).
- •Recent major cardiovascular event including acute coronary syndrome or stroke, or in the past 3 months, chronic liver disease (ALT OR AST > 40 IU, hepatitis B or C)
- •Use of any experimental/investigational drug within 30 days of screening or know hypersensitivity against trial drugs
- •Active or high risk malignancy or treatment for malignancy with in the past 2 years.
- •Uncorrected iron deficiency despite iron supplementations.
- •Acute sepsis as evident by increase C-reactive protein (CRP), Total leukocyte count (TLC).
研究组 & 干预措施
Group A participants will be prescribed Epoetin alpha
Group A, participants will be prescribed epoetin alpha with 50-100 IU/kg body weight.
干预措施: Epoetin Alfa (drug) (Drug)
Group B participants will be prescribed Daprodustat
Group B participants will be prescribed Daprodustat 2mg to 4mg daily and will be titrated as per requirement with maximum dosage of 24mg per day.
干预措施: Daprodustat (Drug)
结局指标
主要结局
Hemoglobin Levels
时间窗: 01 Month
Hemoglobin levels (gm/dl) will be calculated at baseline and after 01 month of Interventions. Mean change in Hemoglobin levels will be calculated.
Serum Ferritin Levels
时间窗: 01 Month
Serum Ferritin levels (ng/ml) will be calculated at baseline and after 01 month of intervention. Mean change in levels will be calculated.
次要结局
未报告次要终点
研究者
Dr Syed Umair Shah Sherazi
Principal Investigator
Services Hospital, Lahore