A Comparative Clinical study to evaluate the Effectiveness and Safety of AGIFER injection in comparison to VENOFER in patients with Iron deficiency anaemia.
Completed
- Conditions
- Patients with Iron deficiency anaemia
- Registration Number
- CTRI/2018/01/011463
- Lead Sponsor
- Agio Pharmaceuticals Ltd
- Brief Summary
A prospective , Interventional, Randomised , Double blind, Parallel Group Comparative Clinical study to Evaluate the Efficacy and Safety of Test drug Agifer Iron sucrose Injection 20 mg/ml ,5ml in comparison with reference drug Venofer iron sucrose Injection 20mg/ml , 5ml in patients with Iron defeciency Anaemia not responding to oral iron. Total of 50 subjects Treatment duration : 56 days Study design : Parallel group, Active controlled, Randomised Both male and female should be included for the study . To assess the efficacy and Safety of Iron sucrose injection by changes in Laboratory Investigation.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 50
Inclusion Criteria
- Male and female patients of age group above 18 years.
- Those willing to give written informed consent and willing to adhere to protocol requirements.
- Chronic kidney disease patients who are dependent or non-dependent on dialysis with iron deficiency anemia.
- 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).
- Iron Deficiency anemia Patients unable to tolerate oral iron therapy because of gastrointestinal side effects (ulcerative colitis, IBD).
- 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).
- Patients with significant blood loss due to any cause and diagnosed with iron deficiency anemia.
- Patients with normal folate and Vit B12 value.
Exclusion Criteria
- 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Changes in Haemoglobin, haematocrit, Ferritin, Iron, transferrin saturation and Total Iron binding capacity. Screening to End of Treatment- Day 56 2.Changes in Average size of RBCs (mean corpuscular volume, MCV), Average amount of haemoglobin in RBCs (mean corpuscular haemoglobin, MCH), Haemoglobin concentration (mean corpuscular haemoglobin concentration, MCHC) and Increased variation in the size of RBCs (red cell distribution width, RDW Screening to End of Treatment- Day 56
- Secondary Outcome Measures
Name Time Method 1.Improvement on Changes in clinical signs and symptoms of iron deficiency anaemia from the screening to end of the treatment. 2.Incidence and rate of adverse events
Trial Locations
- Locations (1)
Rajalakshmi Multispeciality Hospital
🇮🇳Bangalore, KARNATAKA, India
Rajalakshmi Multispeciality Hospital🇮🇳Bangalore, KARNATAKA, IndiaDr Sadanand CDPrincipal investigator09895183173sadanandcd@rediffmail.com