CTRI/2023/11/059727尚未招募4 期
Assessment of the Efficacy and Safety of Desidustat vs Darbepoetin in Anemia due to chronic kidney disease: A Randomized Controlled Trial
Saajid Hameed1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年11月13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
- 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 assess and verify the results of phase 3 trial whether desidustat has efficacy similar to darbepoetin and whether it has acceptable risk-benefit ratio regarding its safety and tolerability. 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
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Current clinical diagnosis of anemia due to CKD, baseline hemoglobin concentrations was to be 7.0-10.0 g/dL (both inclusive) before the enrollment.
- •2.Ability to understand and give informed consent for participation.
- •3.Male or female patients diagnosed with CKD (stage III to IV), defined by estimated glomerular filtration rate (eGFR) using the CKD Epidemiology Collaboration (CKD-EPI) formula.
- •4.Male or female, 18 to 80 years of age.
- •5.Body weight > 40 kg.
- •6.Subjects not on dialysis and not expected to start dialysis during the study period.
- •7.Serum ferritin ≥100 ng/mL and/or TSAT >20%.
- •8.No iron, folate or Vitamin B12 deficiency.
排除标准
- •Prior chronic hemodialysis or chronic peritoneal dialysis treatment.
- •Intravenous iron within 14 days prior to enrollment.
- •Prior exposure of rhEPO analogues less than 04 weeks.
- •Red blood cell transfusion within 8 weeks prior to enrollment.
- •History of previous or concurrent cancer.
- •Serologic status reflecting active hepatitis B or C infection or Human immunodeficiency virus infection.
- •Active infection prior to enrollment.
- •History of renal transplant.
- •Major surgery within 90 days of the first day of study drug dosing, and minor surgery within 30 days of the first day of study drug dosing.
- •Presence or a history of bleeding disorders or clinical conditions that could increase risk of life-threatening bleeding.
- •Pregnant and breastfeeding women.
结局指标
主要结局
Mean change in hemoglobin
时间窗: 0 to 6 months
次要结局
- Time to achieve target range hemoglobin level of 10–12 g/dL(Not Applicable)
- Percentage of time spent in the target hemoglobin range (10-12 g/dl)(0 to 6 months)
- Number of subjects with hemoglobin response defined as target level of 10–12 g/dL and post-treatment increase of 1 g/dL or more by Week 24(0 to 6 months)
- Change in blood cells count(0 to 6 months)
- Change in transferrin saturation(0 to 6 months)
- Change in the lipid, and lipoprotein profile(0 to 6 months)
- Change in potassium levels(0 to 6 months)
- Number (%) of subjects on rescue therapy(0 to 6 months)
- Change in Packed Cell Volume (PCV)(0 to 6 months)
- Change in erythrocyte sedimentation rate (ESR) and C- Reactive Protein (CRP)(0 to 6 months)
研究者
研究点 (1)
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