FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2021/12/039065 [Registered on: 30/12/2021] Trial Registered Prospectively
Last Modified On: 03/03/2022
Post Graduate Thesis  No 
Type of Trial  PMS 
Type of Study   Drug 
Study Design  Single Arm Study 
Public Title of Study   Effect of Ferric Carboxymaltose in population lacking iron in real-liffe scenario. 
Scientific Title of Study   PrescRiption Event MOnitoring for Ferric CarboxyMaltose in Management of Anemia in Indian Real Life ScEnario. (PROMISE) 
Trial Acronym  PROMISE 
Secondary IDs if Any  
Secondary ID  Identifier 
EPL/FCM/PEM/2021/01 Version 1 Dated:24-11-2021   Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Onkar Swami 
Designation  Director Medical Services 
Affiliation  Emcure Pharmaceuticals Ltd 
Address  Emcure Pharmaceuticals Ltd, Survey no 255/2, Phase 1, Rajiv Gandhi ITBT Park, MIDC, Hinjawadi, Pune

Pune
MAHARASHTRA
411057
India 
Phone    
Fax    
Email  Onkar.Swami@emcure.co.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Onkar Swami 
Designation  Director Medical Services 
Affiliation  Emcure Pharmaceuticals Ltd 
Address  Emcure Pharmaceuticals Ltd, Survey no 255/2, Phase 1, Rajiv Gandhi ITBT Park, MIDC, Hinjawadi, Pune

Pune
MAHARASHTRA
411057
India 
Phone    
Fax    
Email  Onkar.Swami@emcure.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Onkar Swami 
Designation  Director Medical Services 
Affiliation  Emcure Pharmaceuticals Ltd 
Address  Emcure Pharmaceuticals Ltd, Survey no 255/2, Phase 1, Rajiv Gandhi ITBT Park, MIDC, Hinjawadi, Pune

Pune
MAHARASHTRA
411057
India 
Phone    
Fax    
Email  Onkar.Swami@emcure.co.in  
 
Source of Monetary or Material Support  
Emcure Pharmaceuticals Limited 
 
Primary Sponsor  
Name  Emcure Pharmaceuticals Limited 
Address  255/2, Rajiv Gandhi IT Park, MIDC, Hinjawadi, Pune -411 057, India  
Type of Sponsor  Pharmaceutical industry-Indian 
 
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 Onkar Swami  Emcure Pharmaceuticals Limited  Department of Medical Services, Ground floor, Head Office Building, Phase 1, Hinjawadi
Pune
MAHARASHTRA 		 9372423101

Onkar.Swami@emcure.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ripon Independent Ethics Committee  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 
Intervention  Injection Ferric Carboxymaltose  Dose: Cumulative dose for repletion of iron using ferric carboxymaltose (FCM) is determined based on the patients body weight and hemoglobin (Hb) level and must not be exceeded. - For Hb 10 g/dl - body weight 35kg: 500mg, body weight 35 kg to 70 kg: 1500 mg, body weight 70 kg and over: 2000 mg. - For Hb 10-14 g/dl - body weight 35kg: 500mg, body weight 35 kg to 70 kg: 1000 mg, body weight 70 kg and over: 1500 mg. - For Hb 14 - body weight 35kg: 500mg, body weight 35kg to 70kg: 500mg, body weight 70kg and over: 500mg. A single Ferric carboxymaltose administration should not exceed 1,000 mg of iron (20 mL FCM). Do not administer 1000 mg of FCM (20 ml) more than once a week. Administration: FCM can be administered as intravenous infusion. It is diluted only in 0.9% NaCl solution. Dilution: FCM 500 mg diluted in 100 ml 0.9% NaCl and FCM 1000 mg diluted in 250 ml 0.9% NaCl. Duration: Minimum administration time for FCM infusion is as follows - 6 minutes for FCM 500 mg and 15 minutes for FCM 1000 mg infusion. 
Comparator Agent  Not Applicable   Not Applicable 
 
Inclusion Criteria  
Age From  14.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Patients with iron deficiency anemia who received Ferric carboxymaltose injection (Orofer FCM) 500/1000 mg in clinical practice as per the locally approved prescribing information and treating physician is ready to share anonymized data of such patients, will be included.
2. Data for hematological parameters (hemoglobin, serum ferritin) are available at baseline and/or for minimum at 4 ± 1 weeks.
 
 
ExclusionCriteria 
Details  1. Any other type of anemia apart from iron deficiency anemia.
2. Severe iron deficiency anemia with hemoglobin < 4 g/dL
3. Evidence of iron overload conditions (e.g. hemochromatosis/hemosiderosis).
4. Any malignancy.
5. Any condition that, in the opinion of the investigator, does not justify the patient’s inclusion in the study.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Adverse events occurring FCM infusion  Till 4 weeks after FCM infusion 
 
Secondary Outcome  
Outcome  TimePoints 
Change in hematological parameters like hemoglobin, serum ferritin, etc.  At baseline and week 4 
 
Target Sample Size   Total Sample Size="2000"
Sample Size from India="2000" 
Final Enrollment numbers achieved (Total)= "1800"
Final Enrollment numbers achieved (India)="1800" 
Phase of Trial   Post Marketing Surveillance 
Date of First Enrollment (India)   03/01/2022 
Date of Study Completion (India) 31/12/2021 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   This is a post-licensure, retrospective, prescription event monitoring, observational study. Data of patients matching the inclusion and exclusion criteria and who received Ferric carboxymaltose (Orofer FCM) as per the locally approved prescribing information, will be retrieved from the medical records by the physicians and filled in the case record forms (CRF) without revealing the patient’s identity. Depending on the availability, data at baseline (before administering FCM) and after 4 (±) 1 weeks for each patient will be filled in the CRF in this way. The completed CRFs will be mailed to Emcure personnel for further analysis and reporting as necessary. Data from the CRFs will be entered into a Microsoft Excel Sheet and analyzed using suitable statistical method. Descriptive statistics will be calculated. Categorical data will be represented in frequencies, percentages. Quantitative data will be described as Mean ± standard deviation (SD). Data generated from this study will be compiled in a final study report. Individual results will not be reported to anyone not directly involved in this research. Research information will be published or presented in a way that does not identify the individual patient and publication of the data will be at the sole discretion of the Study Investigator. 
Close