COMPARATIVE EVALUATION OF EFFICACY AND SAFETY PROFILE OF INTRAVENOUS FERRIC CARBOXYMALTOSE VERSUS IRON SUCROSE IN ADULT PATIENTS WITH SEVERE IRON DEFICIENCY ANAEMIA
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- 2.% Change in Hb, Serum Ferritin levels and Transferrin saturation levels
Study Overview
Brief Summary
All recruited patients will be randomly divided into two groups of Group-A and Group-B. Group-A will receive intravenous Ferric carboxymaltose and Group-B will receive iv Iron sucrose as per their clinical need.
Following routine lab investigations will be done before the treatment begins: CBC (complete blood count), serum iron level, TIBC, TSAT and Serum Ferritin level.
The treatment regimen will be calculated by using the GANZONI formula – Total iron dose= [actual body weight(target Hb – actual Hb)]* 2.4 + iron stores. FCM will be administered in single, once weekly infusions of 1000mg or 500mg iron over at least 15mins duration. Iron sucrose 200-500mg in NS 200ml will be administered slow iv over 3 hours and may be repeated to reach maximum 1gm.
Both the groups A and B will have laboratory investigations done at 2 weeks, 4weeks and 12 weeks and again at 6 months interval to evaluate the changes in Hb level and other baseline characteristics pre and post treatment to see the efficacy of both the drugs in the IDA patients. The adverse reactions if any in both the groups will be recorded in ADR forms generated by IPC (Indian Pharmacopoeia Commission version 1.4). Causality and severity assessment will be done by using WHO-UMC Scale and Modified Hartwig Seigel scale. Quality of life will be assessed by SF-36 questionnaire.
Study Design
- Study Type
- Interventional
- Allocation
- Coin toss, Lottery, toss of dice, shuffling cards etc
- Masking
- Open Label
Eligibility Criteria
- Ages
- 18.00 Year(s) to 80.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •1.Age 18 years and above of either sex.
- •2.All diagnosed patients of severe IDA, attending Clinical Haematology & Medicine Department of SCB Medical College and Hospital, Cuttack.
- •3.TSAT Levels less than 30% 4.He/She must be willing to comply to study protocol till the end of the trial.
- •5.He/She is willing to give written informed consent at the baseline visit.
- •6.All patients will be provided with patient information sheet regarding all pros and cons of the study at the baseline visit.
Exclusion Criteria
- •1.Age<18 years 2.Pregnant and Lactating women 3.Anemia due to any other cause other than IDA 4.Patients with known history of hypersensitivity to iv Iron injection 5.Patients with iron treatment or blood transfusion within 4weeks prior to treatment 6.Patients with recent history of treatment with Erythropoetin.
Outcomes
Primary Outcomes
2.% Change in Hb, Serum Ferritin levels and Transferrin saturation levels
Time Frame: 1. At baseline visit, 2weeks, 4weeks and 12weeks interval.
1.Efficacy of FCM in comparison to iv Iron sucrose in treating IDA using laboratory assays between two groups A and B.
Time Frame: 1. At baseline visit, 2weeks, 4weeks and 12weeks interval.
3.Assessing SAFETY PROFILE of FCM in comparision to iv iron sucrose.
Time Frame: 1. At baseline visit, 2weeks, 4weeks and 12weeks interval.
Secondary Outcomes
- quality of life assesment using SF36 questionnaire(At 4 weeks and 12 weeks interval from the start of the treatment)