CTRI/2020/02/023173已完成3 期
A Prospective, Interventional, Randomised, Double blind, Parallel Group, Comparative Clinical study to evaluate the Efficacy & Safety of test drug, Iron Dextran Injection 100 mg/ 2 ml in the comparison to reference drug, Iron CosmoFer (Iron Dextran Injection 100 mg/ 2 ml) injection in patients with Iron deficiency anemia who is not responding to oral iron therapy
Swiss Parenterals Ltd0 个研究点目标入组 62 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 62
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Male and female patients of age group above
- •18 years to 60 years.
- •2.Those willing to give written informed
- •consent and willing to adhere to protocol
- •requirements.
- •3.Chronic kidney disease patients who are
- •dependent or non dependent on dialysis with
- •iron deficiency anemia.
- •4.Iron deficiency anemia patients not
- •responding to oral iron therapy (i.e.
- •treatment refractory patients/ all patients
- •had been unresponsive or had had poor
- •responses to oral iron therapy (Hb increases < 2 g/dL using 160-200 mg/day of oral ferrous
- •sulphate over 4 weeks of treatment).
- •5.Iron Deficiency anemia Patients unable to
- •tolerate oral iron therapy because of
- •gastrointestinal side effects (ulcerative
- •colitis, IBD).
- •6.Pregnant ladies with haemoglobin level 5-9 g%
- •with diagnosed iron deficiency attending
- •antenatal clinic (if the treating physician
- •finds a need for parenteral iron therapy).
- •7.Patients with significant blood loss due to
- •any cause and diagnosed with iron deficiency
- •8.Patients with normal folate and Vit B12
排除标准
- •1. Patients with known hypersensitivity to iron
- •dextran or any component of the formulation.
- •2. Patients with Other causes of anemia other
- •than iron deficiency (vitamin B12 or folate
- •deficiency, etc.)
- •3.Patients with microcytic iron-overloading
- •disorder (thalassemia, sideroblastic anemia)
- •4.Chronic alcohol abuse (alcohol consumption
- •>20 g/day).
- •5.Presence of portal hypertension with
- •oesophageal varices.
- •6.Patients who have received erythropoietin,
- •intravenous iron therapy, or blood
- •transfusion 4 weeks prior to screening.
- •7.Chronic liver disease or increase of liver
- •enzymes (alanine aminotransferase ([ALT],
- •aspartate aminotransferase [AST]) >3 times
- •the upper limit of normal range.
- •8.Patients with positive serology at the time
- •of screening.
- •9.Significant cardiovascular disease, including
- •myocardial infarction within 12 months prior
- •to study inclusion, congestive heart failure
- •NYHA (New York Heart Association) grade III
- •or IV, or poorly controlled hypertension
- •according to the judgment of the
- •investigator.
- •10.Currently participating in another
- •investigational study or has participated in
- •an investigational study within 30 days prior
- •to randomization.
- •11.Has any other serious disease or condition
- •that would compromise subject safety or make
- •it difficult to successfully manage and
- •follow the subject according to the protocol.
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