CTRI/2024/02/062658已完成4 期
Randomized controlled trial to compare the safety and efficacy of desidustat with erythropoietin in adult patient suffering from anemia in chronic kidney disease.
Dr Sachin Sharma1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2024年2月14日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Mean change in hemoglobin.
研究概览
简要总结
Our plan is to conduct a randomized trial to compare the safety and efficacy of desidustat with erythropoietin. The result of this study will generate more evidence for the clinician to use this drug in pharmacotherapy of anemia due to CKD. The study result will add to current limited evidence of newly approved drug desidustat for its efficacy and safety for its use in anemia due to CKD. If acceptable risk-benefit ratio is proven, this drug can also be utilized in other causes of anemia where there is role of hepcidin in the pathophysiology of the anemia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 95.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient willing to give written informed consent.
- •2.Age more than 18 years.
- •3.Male or female patient with current clinical diagnosis of anemia due to CKD having baseline hemoglobin concentrations ≤10.0 g/dl before the enrolment.
- •If patients are on dialysis they should be on adequate dialysis (as prescribed) on either 2 or 3 times per week hemodialysis for at least 12 weeks prior to screening.
- •Patients with no planned renal transplant during study period.
- •Adequate serum ferritin and/or TSAT as per KDIGO guidelines.
- •No iron, folate or vitamin B12 deficiency.
排除标准
- •1.Age less than 18 years.
- •2.Patients who received red blood cell transfusion within 8 weeks prior to enrollment.
- •3.Hematological malignancy or primary hematological disease.
- •4.Malignancy of any organ.
- •5.Presence or a history of bleeding disorder.
- •6.Serological status reflecting active hepatitis B or C or Human immunodeficiency virus (HIV) infection.
- •7.History of renal transplant.
- •8.Unable to swallow tablets or disease significantly affecting gastrointestinal function and/or inhibiting small intestinal absorption such as mal absorption syndrome, resection of small bowel or poorly controlled inflammatory bowel disease affecting small intestine.
- •9.History of uncontrolled autoimmune hemolytic anemia, idiopathic thrombocytopenic purpura (ITP) or thalassemia.
- •10.Known hypersensitivity to investigational products or with known contraindications to any of the study drug.
- •11.Women who are trying to conceive, pregnant and breast-feeding women.
结局指标
主要结局
Mean change in hemoglobin.
时间窗: Baseline to 3 months
次要结局
- Change in hematological and biochemical parameters as mentioned in protocol annexure III) before and after receiving drug like Serum Hepcidin level, Vitamin D, Phosphate, Parathormone, Lipid Profile
研究者
Dr Sachin Sharma
Dr Rajendra Prasad Government Medical College Tanda HP
研究点 (1)
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