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CTRI Number  CTRI/2022/12/048152 [Registered on: 15/12/2022] Trial Registered Prospectively
Last Modified On: 25/09/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Intravenous Ferric carboxy maltose in the treatment of severe iron deficiency anaemia patients 
Scientific Title of Study   COMPARATIVE EVALUATION OF EFFICACY AND SAFETY PROFILE OF INTRAVENOUS FERRIC CARBOXYMALTOSE VERSUS IRON SUCROSE IN ADULT PATIENTS WITH SEVERE IRON DEFICIENCY ANAEMIA 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Subhashree Kar 
Designation  Post Graduate Trainee, Pharmacology 
Affiliation  SCB Medical college and hospital, Cuttack 
Address  PG DEPARTMENT OF PHARMACOLOGY, SCB MEDICAL COLLEGE AND HOSPITAL, CUTTACK

Cuttack
ORISSA
753007
India 
Phone  7681851840  
Fax    
Email  kar.subhashree1502@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Trupti Rekha Swain 
Designation  Professor and Head of the Department, Pharmacology 
Affiliation  SCB Medical College and Hospital, Cuttack  
Address  PG Department of Pharmacology, SCB MEDICAL COLLEGE AND HOSPITAL, CUTTACK

Cuttack
ORISSA
753007
India 
Phone    
Fax    
Email  drtruptiswain@gmail.com  
 
Details of Contact Person
Public Query  
Name  Trupti Rekha Swain 
Designation  Professor and Head of the Department, Pharmacology 
Affiliation  SCB Medical College and Hospital, Cuttack  
Address  PG Department of Pharmacology, SCB MEDICAL COLLEGE AND HOSPITAL, CUTTACK

Cuttack
ORISSA
753007
India 
Phone    
Fax    
Email  drtruptiswain@gmail.com  
 
Source of Monetary or Material Support  
SCB Medical College and Hospital, Cuttack, 753007 
 
Primary Sponsor  
Name  Subhashree Kar 
Address  PG Department of Pharmacology, SCB Medical College and Hospital, Cuttack-753007 
Type of Sponsor  Other [Individual] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Subhashree Kar  SCB MEDICAL COLLEGE AND HOSPITAL, CUTTACK 753007  OPD ROOM, IPD ROOM AND DAYCARE OF DEPARTMENT OF CLINICAL HEMATOLOGY
Cuttack
ORISSA 		 7681851840

kar.subhashree1502@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE, SCB MEDICAL COLLEGE AND HOSPITAL, CUTTACK-753007  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: D508||Other iron deficiency anemias,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  INTRA VENOUS FERRIC CARBOXY MALTOSE  IV Ferric carboxy maltose(FCM) is a third generation parenteral iron preparation designed to overcome the limitations of existing parenteral iron preparations especially used for moderate to severe iron deficiency anemia(IDA). FCM will be administered intravenous once weekly to patients with severe IDA( WHO-Hb less than 7gm%) in the dose range of 500-1000mg by the treating physician at Department of Clinical Hematology, SCB MCH, Cuttack after calculating the iron requirement using Ganzoni formula and seeing the weight band of the patient. 
Comparator Agent  IV IRON SUCROSE  Iron Sucrose is given 200mg in 100ml normal saline slow iv once weekly for 4 weeks or as required by patient. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  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. 
 
ExclusionCriteria 
Details  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. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1.Efficacy of FCM in comparison to iv Iron sucrose in treating IDA using laboratory assays between two groups A and B.
2.% Change in Hb, Serum Ferritin levels and Transferrin saturation levels
3.Assessing SAFETY PROFILE of FCM in comparision to iv iron sucrose. 		 1. At baseline visit, 2weeks, 4weeks and 12weeks interval. 
 
Secondary Outcome  
Outcome  TimePoints 
quality of life assesment using SF36 questionnaire   At 4 weeks and 12 weeks interval from the start of the treatment 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   20/12/2022 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  

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.

 
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