â??A Prospective, Interventional, Randomised, Double blind, Parallel Group, Comparative Clinical study to evaluate the Efficacy & Safety of test drug AGIFER (Iron Sucrose Injection 20 mg/ ml, 5 ml) injection in comparison to reference drug VENOFER (Iron Sucrose Injection 20 mg/ ml, 5 ml) in patients with Iron deficiency anaemia not responding to oral iron.â??

Agio Pharmaceuticals Ltd0 个研究点目标入组 50 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1. Male and female patients of age group above 18 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 less than 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 hemoglobin 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 anemia.
•8. Patients with normal folate and Vit B12 value.

•1.Patients with known hypersensitivity to iron sucrose 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 more than 20 g/day).
•5.Presence of portal hypertension with esophageal 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]) more than 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.Received another investigational agent within 4 weeks prior to screening, or planned receipt of an investigational agent
•11.Patients with body weight less than 30kg
•12. Inability to fully comprehend and performstudy procedures in the Investigator opinion.

发起方

Agio Pharmaceuticals Ltd