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CTRI Number  CTRI/2024/12/078707 [Registered on: 30/12/2024] Trial Registered Prospectively
Last Modified On: 27/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   "Efficacy and Safety Comparison of Intravenous Ferric Carboxymaltose vs. Iron Isomaltoside in Moderate to Severe Iron Deficiency Anemia: A Prospective, Randomised Study" 
Scientific Title of Study   Comparison of efficacy and safety of intravenous ferric carboxymaltose versus intravenous iron (III) isomaltoside 1000 in the treatment of patients with moderate to severe iron deficiency anemia: A prospective, randomized, open-labelled, active controlled study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Anant Khot 
Designation  Additional Professor 
Affiliation  All India Institute of Medical Sciences Nagpur 
Address  Department of Pharmacology All India Institute of Medical Sciences Nagpur Plot No. 2 Sector 20 MIHAN Nagpur Maharashtra

Nagpur
MAHARASHTRA
441108
India 
Phone    
Fax    
Email  dranantkhot@aiimsnagpur.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Nandini N A 
Designation  Junior Resident 
Affiliation  All India Institute of Medical Sciences Nagpur 
Address  Department of Pharmacology All India Institute of Medical Sciences Nagpur Plot No. 2 Sector 20 MIHAN Nagpur Maharashtra

Nagpur
MAHARASHTRA
441108
India 
Phone  8151893392  
Fax    
Email  nandinisastry6@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Nandini N A 
Designation  Junior Resident 
Affiliation  All India Institute of Medical Sciences Nagpur 
Address  Department of Pharmacology All India Institute of Medical Sciences Nagpur Plot No. 2 Sector 20 MIHAN Nagpur Maharashtra

Nagpur
MAHARASHTRA
441108
India 
Phone  8151893392  
Fax    
Email  nandinisastry6@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences Nagpur Plot No 2 Sector 20 MIHAN Nagpur Maharashtra India Pin 441108 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences Nagpur 
Address  All India Institute of Medical Sciences Nagpur Plot No. 2 Sector 20 MIHAN Nagpur Maharashtra Pin 441108 
Type of Sponsor  Other [Institution of National Importance] 
 
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 
Dr Anant Khot  All India Institute of Medical Sciences Nagpur  Department of Pharmacology, Department of General Medicine, Department of OBG, Department of Nephrology, AIIMS Nagpur Plot No 2 Sector 20 MIHAN Nagpur Maharashtra 441108
Nagpur
MAHARASHTRA 		 9591926519

dranantkhot@aiimsnagpur.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee AIIMS Nagpur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: D509||Iron deficiency anemia, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Ferric carboxymaltose  dose 1g schedule single dose strength 20ml of 50mg/ml drug to be administered brand name Maltoxy manufacturer INTAS route intravenous slow infusion  
Intervention  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 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  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 
 
ExclusionCriteria 
Details  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 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
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 study  4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
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 study  4 weeks 
Adverse events occurring during the study period will be used to assess the safety outcomes  day 0 to day 28 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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   Phase 3 
Date of First Enrollment (India)   10/01/2025 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

·      Anemia is a major public health problem worldwide. It has significant public health implications with social and economic consequences especially in a country like India.This study might reveal one drug to be more effective or have a better safety profile than the other. This could inform physicians when choosing the most appropriate treatment for their patients with moderate to severe iron deficiency anemia. This study could provide valuable data for the first head-to-head comparison of ferric carboxymaltose and iron (III) isomaltoside 1000 for moderate to severe iron deficiency anemia.  By potentially leading to more effective and well-tolerated treatment options, the study’s findings could improve patient outcomes for those suffering from moderate to severe iron deficiency anemia.

 
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