Clinical study to evaluate the Efficacy and Safety of test drug Iron Dextran Injection 100 mg per 2 ml in the comparison to reference drug Iron CosmoFer injection in patients with Iron deficiency anemia who is not responding to oral iron therapy
- Conditions
- Iron deficiency anemia,
- Registration Number
- CTRI/2020/02/023173
- Lead Sponsor
- Swiss Parenterals Ltd
- Brief Summary
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
35 days (Depends on patients condition around 4 weeks treatment + Follow up after 7 ±3 days of completion of treatment)
Male or female patients with the age group from 18 to 60 years old having iron deficiency anemia who is not responding to oral iron therapy/ dialysis treated with Erythropoietin/ intolerance to oral iron preparations/ inflammatory gastrointestinal disorders etc.
62 subjects completed the study.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 74
- 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 anemia.
- 8.Patients with normal folate and Vit B12 value.
- Patients with known hypersensitivity to iron dextran or any component of the formulation.
- 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.
- 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Improvemental Changes in Haemoglobin (Hb), haematocrit (HCT), Ferritin, Iron (Fe), transferrin saturation (TSAT) and Total Iron binding capacity (TIBC) value from the screening to end of the treatment From the screening to end of the treatment
- Secondary Outcome Measures
Name Time Method 1.Improvemental Changes in Average size of RBCs Average amount of haemoglobin in RBCs , Haemoglobin concentration and Increased variation in value 2.Improvement on Changes in clinical signs and symptoms of iron deficiency anemia
Trial Locations
- Locations (2)
People Tree Hospitals Clinical Research Center
🇮🇳Bangalore, KARNATAKA, India
Prakriya Hospitals
🇮🇳Bangalore, KARNATAKA, India
People Tree Hospitals Clinical Research Center🇮🇳Bangalore, KARNATAKA, IndiaDr Saikiran SPrincipal investigator6361253143drsaikiran@peopletreehospitals.com