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CTRI Number  CTRI/2025/09/093973 [Registered on: 01/09/2025] Trial Registered Prospectively
Last Modified On: 03/11/2025
Post Graduate Thesis  No 
Type of Trial  BA/BE 
Type of Study    
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A Clinical to Compare Two Iron Medicines for Treating Iron Deficiency Anaemia in Adults 
Scientific Title of Study   A Randomized, Double-Blind, Multicentre, Parallel, Two-Arm, Therapeutic Equivalence Study comparing Iron (III) Hydroxide Polymaltose 100mg Hard Gelatin Capsules to Maltofer® 370 mg Tablets (100mg iron as iron polymaltose) in the treatment of Iron Deficiency Anaemia in Non-Pregnant Women, and Men. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
GRCT-23-001 Version 5.0 dated17/06/2025   Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Pankaj Patil 
Designation  Medical Monitor 
Affiliation  Genecht Research Pvt. Ltd. 
Address  Genecht Research Pvt. Ltd. Plot No. D-400, TTC Industrial Area, MIDC Nerul, Uran Phata Junction, Off Sion - Panvel Expiry, Nerul, Navi Mumbai-400 706, Maharashtra, India.

Mumbai
MAHARASHTRA
400706
India 
Phone  9987154253  
Fax    
Email  pankaj.patil@genechtresearch.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Pankaj Patil 
Designation  Medical Monitor 
Affiliation  Genecht Research Pvt. Ltd. 
Address  Genecht Research Pvt. Ltd. Plot No. D-400, TTC Industrial Area, MIDC Nerul, Uran Phata Junction, Off Sion - Panvel Expiry, Nerul, Navi Mumbai-400 706, Maharashtra, India.


MAHARASHTRA
400706
India 
Phone  9987154253  
Fax    
Email  pankaj.patil@genechtresearch.com  
 
Details of Contact Person
Public Query  
Name  Dr Pankaj Patil 
Designation  Medical Monitor 
Affiliation  Genecht Research Pvt. Ltd. 
Address  Genecht Research Pvt. Ltd. Plot No. D-400, TTC Industrial Area, MIDC Nerul, Uran Phata Junction, Off Sion - Panvel Expiry, Nerul, Navi Mumbai-400 706, Maharashtra, India.


MAHARASHTRA
400706
India 
Phone  9987154253  
Fax    
Email  pankaj.patil@genechtresearch.com  
 
Source of Monetary or Material Support  
AFT Pharmaceuticals PO Box 33-203, Takapuna, Auckland 0740 Level 1, A.C.Nielsen House, 129 Hurstmere Rd, Takapuna, Auckland 0622  
 
Primary Sponsor  
Name  AFT Pharmaceutical 
Address  AFT Pharmaceuticals PO Box 33-203, Takapuna, Auckland 0740 Level 1, A.C.Nielsen House, 129 Hurstmere Rd, Takapuna, Auckland 0622  
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
Nil  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 8  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Jasmina Begum  AIIMS Bhubaneswar   AIIMS Bhubaneswar, OPD , Departmemt of Gynecology Sijua, Patrapada, Bhubaneswar, Odisha-751019
Khordha
ORISSA 		 9443392737

obgyn_jasmina@aiimsbhubaneswar.edu.in  
Dr Mahendra Pal Singh   G.S.V.M Medical College Kanpur  Room No. 10, Ground Floor, Post Graduate Department of Medicine GSVM Medical College Sawroop Nagar Kanpur 208002 U.P., India
Kanpur Nagar
UTTAR PRADESH 		 8765379671

drmahendrapalsingh@gmail.com 
Dr Dipali Prasad  Indira Gandhi Institute of Medical Sciences  Department of Obst & Gynecology Indira Gandhi Institute of Medical Sciences, Patna,800014
Patna
BIHAR 		 9708316233

dr.dipalipd@gmail.com 
Dr Rakesh Bahadur   Janta Hospital and Maternity centre   OPD No. 1, Ground Floor, Janta Hospital & Maternity centre, amara-akhari bypass, varanasi-221011, Uttar Pradesh
Varanasi
UTTAR PRADESH 		 9235310199

jantahospitalvns@gmail.com 
Dr Mousumi Acharya   KIMS Hospital  Deapartment of Gynecology, Ground floor OPD KIMS Hospital, kushabhadra Campus (KIIT Campus-5) Patia, Bhubaneshwar, Odisha, 751024
Khordha
ORISSA 		 9556026322

mousumi.acharya@kims.ac.in 
Dr Garima Singh  Krishna Hospital  OPD No. 1, Ground floor, Krishna Hospital, Amra, Chitaipur Road, Akhri bypass, Varanasi-221005, UP
Varanasi
UTTAR PRADESH 		 8528221044

drsinghgarimal12@gmail.com 
Dr Poonam Yadav   S. N. Medical College  OPD room no.4, Ground Floor, Department of Obstetrics and Gynaecology, S. N. Medical College, Moti Katra, Mantola, Agra-282003 Uttar Pradesh, India
Agra
UTTAR PRADESH 		 9411922686

dr.poonamneeraj@gmail.com 
Dr Shubhangi Shahare  Saikrupa Hospital  Saikrupa Hospital, Ground floor OPD, Department of Gynecology Renuka Corner, Tapkir chowk, Thergaon Pune, 411033
Pune
MAHARASHTRA 		 9420697292

drshubhangi2@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 9  
Name of Committee  Approval Status 
ETHICS COMMITTEE GSVM MEDICAL COLLEGE  Approved 
Ford Hospital Ethics committee  Approved 
IEC, GCS Medical College, Hosp and Research Centre   Approved 
Institutional Ethics Committee S.N Medical  Submittted/Under Review 
INSTITUTIONAL ETHICS COMMITTEE, AlIMS  Submittted/Under Review 
Institutional Ethics Committee, IGIMS ,Sheikhpura  Approved 
Institutional Ethics Committee-KIMS  Submittted/Under Review 
Krishna Ethics Committee  Approved 
Saikrupa Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: D509||Iron deficiency anemia, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Iron (III) Hydroxide Polymaltose 100mg Hard Gelatin Capsules  once daily for 12 weeks 
Comparator Agent  Maltofer® 370 mg Tablets (100mg iron as iron polymaltose)  once daily for 12 weeks 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  - Adult male patients, non-pregnant female patients aged 18 years and above with a diagnosis of iron deficiency anaemia on the screening day and willing to provide written informed consent form to participate in the study.
- Diagnosed iron deficiency anaemia based on 2 criteria:
a.Haemoglobin level below 110 g per L but should be above 60 g per L.
b.Serum ferritin level below 30 micro g per L.
•Patients must be willing and able to understand and comply with the requirements of the protocol, including attendance at the required study visits.
•Non-pregnant females and males diagnosed with iron deficiency anaemia are eligible.
•Female patients of childbearing potential must have a negative urine pregnancy per Beta-hCG results and should follow abstinence or use contraceptive methods with a failure rate of less than 1 percent
 
 
ExclusionCriteria 
Details  Administration of any iron-containing drugs during the last3 months.
- History of erythropoietin drug administration.
- Hypersensitivity to iron therapy both Oral and or IV administration and other components of the study drugs.
- Hormone therapy including the use of androgens or anabolic steroids or administration of drugs that inhibit blood formation, less than 3 months before the start of the study.
- History of severe allergic reactions or drug intolerance.
-Fructose intolerance, glucose-galactose malabsorption syndrome, and sucrase isomaltase deficiency.
- Failure of iron therapy for iron-deficiency anaemia in a patients past medical history.
- Heme metabolism disorders eg sideroachrestic anaemia, lead anaemia, thalassemia.
- Iron overload including hemochromatosis and hemosiderosis.
- Other causes of anaemia, apart from iron deficiency, including
- Haemolysis determined as per analysis results at screening, or as per anamnestic data.
- Vitamin B12 and folic acid deficiency as per the screening data.
- Chronic kidney disease creatinine clearance at screening is below 90 ml per min based on Cockcroft Gault Formula.
- Systemic connective tissue diseases, chronic infectious diseases requiring regular therapy as per the past medical history, and other conditions which may, in the investigators opinion, be accompanied by anaemia of chronic diseases.
Dysfunction of the thyroid gland based on the data obtained at screening. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
Change in blood haemoglobin level   Baseline and week 12  
 
Secondary Outcome  
Outcome  TimePoints 
Change in serum iron  baseline, weeks 4,week 8 and week 12 
Change in Transferrin  Baseline, week 4, week 8 and week 12 
Change in Percent Transferrin saturation  Baseline, week 4, week 8 and week 12 
Change in ferritin  Baseline, week 4, week 8 and week12 
Number of patients with a response to the therapy  Baseline and week 12 
 
Target Sample Size   Total Sample Size="240"
Sample Size from India="240" 
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)   15/09/2025 
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 Yet Recruiting 
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   This randomized, double-blind, multicentre, two-arm study evaluates the bioequivalence and therapeutic equivalence of Iron (III) Hydroxide Polymaltose 100mg Hard Gelatin Capsules versus Maltofer® 370 mg Tablets in non-pregnant women and men with iron deficiency anaemia. The primary objective is to assess changes in haemoglobin from baseline to week 12, with secondary objectives including serum iron, transferrin, transferrin saturation, ferritin levels, safety profile, and overall response to therapy. Ethical standards, informed consent, and regulatory compliance are maintained. Results aim to confirm comparable efficacy and safety, supporting improved iron supplementation strategies for managing iron deficiency anaemia in alignment with global health recommendations. 
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