| CTRI Number |
CTRI/2023/01/048725 [Registered on: 04/01/2023] Trial Registered Prospectively |
| Last Modified On: |
03/01/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of different types of Injectable iron in the treatment of Iron Deficiency Anemia |
|
Scientific Title of Study
|
A phase III, randomised, single blind, comparative safety, efficacy and cost effectiveness trial of intravenous iron isomaltoside (i3R) and Ferric Carboxy Maltose (FeriumR) in subjects with iron deficiency anemia |
| Trial Acronym |
SCIFI |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1286-2021 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Uday yanamandra |
| Designation |
Professor |
| Affiliation |
Armed Forces Medical College |
| Address |
Dept of Internal Medicine,Solapur road
AFMC,
Pune
MAHARASHTRA
411040
India |
| Phone |
8195035551 |
| Fax |
|
| Email |
udayj2@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Uday yanamandra |
| Designation |
Professor |
| Affiliation |
Armed Forces Medical College |
| Address |
Dept of Internal Medicine,Solapur road
AFMC,
Pune
MAHARASHTRA
411040
India |
| Phone |
8195035551 |
| Fax |
|
| Email |
udayj2@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Uday yanamandra |
| Designation |
Professor |
| Affiliation |
Armed Forces Medical College |
| Address |
Dept of Internal Medicine,Solapur road
AFMC,
Pune
MAHARASHTRA
411040
India |
| Phone |
8195035551 |
| Fax |
|
| Email |
udayj2@gmail.com |
|
|
Source of Monetary or Material Support
|
| Armed Forces Medical College, Pune |
|
|
Primary Sponsor
|
| Name |
Armed Forces Medical College |
| Address |
Dept of Internal Medicine, AFMC
Solapur road, Pune Maharashtra
India,411040 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Uday Yanamandra |
Armed Forces Medical college |
Dept of Hematology, Medical Division, Block 7, 3rd Floor
Pune
MAHARASHTRA |
819505551
udayj2@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, AFMC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
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 carboxy maltose (FCM) |
ferric carboxy maltose (FCM) will be administered as 1000 mg at baseline diluted in 250 mL 0.9 % sodium chloride injections over approximately 15-20 minutes. No premedication (e.g. antihistamine or steroids) is given before administration of the drug. It is given only once at the baseline, and it is not readministered during the trial period as per trial protocol. In case of necessity for re-administration, the same is recorded in the follow-up proforma and will be analyzed separately. |
| Intervention |
Iron Isomaltoside(i3) |
Iron isomaltoside will be administered as a single IV infusion of 1000 mg at baseline diluted in 100 mL 0.9 % sodium chloride and given over approximately 20 minutes (50 mg iron/min). No premedication (e.g. antihistamine or steroids) is given before administration of the drug. It is given only once at the baseline, and it is not readministered during the trial period as per trial protocol. In case of necessity for re-administration, the same is recorded in the follow-up proforma and will be analyzed separately. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects having IDA are caused by nutritional and different aetiologies of blood loss such as abnormal uterine bleeding, gastrointestinal diseases, and bariatric procedures (gastric bypass operations.
2. Subjects with intolerance to oral iron
3. Hb ≤ 11 g/dL
4. TSAT < 20 %
5. S-ferritin < 100 ng/mL
6. Willingness to participate and sign the informed consent form
|
|
| ExclusionCriteria |
| Details |
1. Known hypersensitivity reaction to any component of iron isomaltoside or FCM
2. Previous serious hypersensitivity reactions to any IV iron compounds
3. Previously randomized in a clinical trial with iron isomaltoside
4, Received an investigational drug within 30 days of screening
5. During the 10 days before screening; has been treated with IV iron
6. Erythropoiesis stimulating agent (ESA) treatment within 30 days before the screening visit
7. During the 30 days before screening or during the trial period; has or will require a surgical procedure that necessitates general anesthesia
8. Any non-viral infection
9. Required dialysis for treatment of CKD
10. Any other laboratory abnormality, medical condition, or psychiatric disorder which, in the opinion of the investigator, will put the subject’s disease management at risk or may result in the subject being unable to comply with the trial requirements
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate and compare the effect and cost-effectiveness of iron isomaltoside to FCM in its ability to increase Hb and Ferritin in subjects with IDA
|
4weeks, 8 weeks, 12 weeks and 24 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate and compare the effect of iron isomaltoside to FCM on (a) Other relevant iron related biochemical parameters (b) Fatigue symptoms (c) Pharmacoeconomics
|
4 weeks
8 weeks
12 weeks
24 weeks |
|
|
Target Sample Size
|
Total Sample Size="280"
Sample Size from India="280"
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)
|
05/01/2023 |
| 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)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Anemia is a significant public health problem involving all stages of the life cycle but is more prevalent in pregnant women and young children. Iron deficiency is the most critical contributor (>50%) to the anemia globally, to the extent that the terms iron deficiency anemia (IDA) and anemia are often used interchangeably. IDA can have a substantial medical and quality of life (QoL) burden on the subjects, and treatment of these subjects includes controlling the bleeding and replenishing lost iron. Oral iron is considered first-line therapy for IDA because of its low cost, perceived safety profile, and ease of administration. Nonetheless, the oral iron absorption is affected by several dietary factors (particularly high phytate content in the Indian diet); also, the high incidence of gastrointestinal side effects leads to poor compliance to therapy. Parenteral iron therapy on the other hand, leads to rapid replenishment of iron stores. Ferric carboxy maltose (FCM) has largely replaced other forms of parenteral iron preparation in India due to its acceptable dosing schedule and lower side effect profile. However, cost of treatment with FCM is a major limiting factor in its use along with notable hypophosphatemia. It is therefore, this product has been chosen as comparator in this trial which is planned to evaluate the safety,efficacy and cost effectiveness of intravenous (IV) iron isomaltoside(i3) compared to IV FCM in subjects with IDA. |