Health Condition 1: D50- Iron deficiency anemia
Conditions
Interventions
Intervention1: Iron Dextran Injection: Iron Dextran Injection 100 mg/ 2 ml will be administered according to total iron deficit in alternative day on 4 to 5different occasions within a 14 day period t
Sponsors
Swiss Parenterals Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 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 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 treatmentTimepoint: From the screening to end of the treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 3.Incidence of Adverse events and Serious Adverse Events throughout the trial duration. Timepoint: From the screening to end of the treatment | — |
Countries
India
Contacts
Public ContactDr Harish S
ICBio Clinical Research Pvt. Ltd
Outcome results
None listed