Health Condition 1: D509- Iron deficiency anemia, unspecified
Conditions
Interventions
Intervention1: Iron (III) isomaltoside 1000: dose 1g
schedule single dose
strength 10ml of 100mg/ml drug to be administered
brand name FerUno
manufacturer ZYDUS
route intravenous slow infusion
Cont
Sponsors
All India Institute of Medical Sciences Nagpur
Eligibility
Inclusion criteria
Inclusion criteria: Male and female patients aged between 18 to 65 years inclusive of both, will be included. Additionally, hemoglobin values should be greater than 6.5g/dl and less than 10g/dl, body weight should be more than 50kg, there should be a history of unresponsiveness or intolerance to oral iron therapy for at least one month before enrolment in the study
Exclusion criteria
Exclusion criteria: acute bleeding of more than 500ml in the past 72 hours, anemia caused predominantly by factors other than iron deficiency as decided by the investigator, known hypersensitivity to any component of ferric carboxymaltose or iron (III) isomaltoside 1000, history of hemochromatosis or any iron overload states, received intravenous iron treatment 30 days prior to enrolment in the study, received treatment with erythropoietin or erythropoietin-stimulation agents, red blood cell transfusion, radiotherapy and/or chemotherapy 30 days prior to enrolment in the study, raised alanine transaminase and aspartate transaminase 3 or more times above the upper limit of normal, pregnant and lactating women, history of hemoglobinopathies, thalassemia, bleeding manifestations, patients requiring dialysis, documented history of malignancy, patients with psychiatric disorders, patients not willing to participate in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change in mean value of hemoglobin at the end of 4 weeks after administration of study drug will be the primary efficacy outcome of the studyTimepoint: 4 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in the mean value of iron profile (serum iron, serum ferritin, transferrin saturation, TIBC) at the end of 4 weeks after administration of study drug will be the secondary efficacy outcome of the studyTimepoint: 4 weeks;Adverse events occurring during the study period will be used to assess the safety outcomesTimepoint: day 0 to day 28 | — |
Countries
India
Contacts
Public ContactDr Nandini N A
All India Institute of Medical Sciences Nagpur
Outcome results
None listed