| CTRI Number |
CTRI/2024/09/074184 [Registered on: 23/09/2024] Trial Registered Prospectively |
| Last Modified On: |
20/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trail to study the effects of two drugs Iron isomaltoside and Ferric carboxymaltose in patient with Iron Deficiency Anemia. |
|
Scientific Title of Study
|
Iron isomaltoside versus Ferric carboxymaltose in
Iron Deficiency Anemia: A randomized clinical trial |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Maj Dr D Mohanasundharam |
| Designation |
Post Graduate Student in Medicine (MD) |
| Affiliation |
COMMAND HOSPITAL (CENTRAL COMMAND) LUCKNOW |
| Address |
Maj Dr D Mohanasundharam
Junior resident Medicine
Department OF Medicine (Medical Division)
Command Hospital central command
Lucknow
Maj Dr D Mohanasundharam
Junior resident Medicine
Department OF Medicine
Room no 214 Single officer Accomdation 30 mg RLB Marg Nail Lines
Lucknow 226002
Lucknow
UTTAR PRADESH
226002
India |
| Phone |
9682346746 |
| Fax |
|
| Email |
drmohaa472@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Col (DR) Kundan Mishra |
| Designation |
HOD Haematology |
| Affiliation |
COMMAND HOSPITAL (CENTRAL COMMAND) LUCKNOW |
| Address |
Col(Dr) Kundan Mishra
MD (Medicine),DM(clinical Hematology
Room No 1
Departmentof medicine)
Command Hospital Central Command Lucknow
Lucknow
UTTAR PRADESH
226002
India |
| Phone |
9871323179 |
| Fax |
|
| Email |
mishrak20@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Maj Dr D Mohanasundharam |
| Designation |
Post Graduate Student in Medicine (MD) |
| Affiliation |
COMMAND HOSPITAL (CENTRAL COMMAND) LUCKNOW |
| Address |
Maj Dr D Mohanasundharam
Junior resident Medicine
Department OF Medicine (Medical Division)
Command Hospital (central command)
Lucknow
Maj Dr D Mohanasundharam
Junior resident Medicine
Department OF Medicine
Room no 214 Single officer Accomdation 30 mg RLB Marg Nail Lines
Lucknow 226002
Lucknow
UTTAR PRADESH
226002
India |
| Phone |
9682346746 |
| Fax |
|
| Email |
drmohaa472@gmail.com |
|
|
Source of Monetary or Material Support
|
| Command Hospital
Central Command
Lucknow
Uttar Pradesh
India
PIN 262002 |
|
|
Primary Sponsor
|
| Name |
Command Hospital |
| Address |
Command Hospital
Central Command
Lucknow
Uttar Pradesh
India
PIN 262002 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Maj Dr D Mohanasundharam |
COMMAND HOSPITAL CENTRAL COMMAND |
Room no 1
Department of
Medicine
Medical Division
Lucknow
UTTAR PRADESH |
9682346746
drmohaa472@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe Command Hospital Central Command |
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 |
Inj.Ferric carboxymaltose IV Infusion |
Inj.Ferric carboxymaltose upto 1000 mg IV infusion will be administered (per wee kx 2 weeks) |
| Intervention |
Inj.Iron isomaltoside IV infusion |
Inj.Iron isomaltoside upto 1000 mg IV infusion will be administered (per weekx 2 weeks) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Hemoglobin less than 13g/dL male, and less than
12g/dL female
2. Mean corpuscular volume less than 80 fL
3. Transferrin saturation less than 20%
4. S Ferritin less than 50 ng/mL male, 30 ng/mL
for female |
|
| ExclusionCriteria |
| Details |
1. Patients receiving other modalities of treatment and/or alternative medicine.
2. Patients who did not consent for the study.
3. Patients with CKD, CLD, malignancy, hemoglobinopathy, and pregnant ladies.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Increase in Hemoglobin
|
06 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Rise in Hemoglobin
2. Reticulocyte response
3. Time required to achieve hemoglobin response.
4. Safety profile
|
2 weeks & 4 weeks & 06 weeks after initiation of therapy |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
04/10/2024 |
| 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="6"
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [drmohaa472@gmail.com].
- For how long will this data be available start date provided 01-03-2026 and end date provided 01-03-2031?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
Management of iron deficiency anemia using intravenous (IV) iron preparation is currently well established. However, there are not safe and effective options. The commonly used IV Iron preparation in our clinical setting is ferric carboxymaltose (FCM).
Iron isomaltoside is a new intravenous (IV) iron preparation. However, it is not being used by us as the Indian data on safety and efficacy are scarce. In this study we aim to compare the safety and efficacy of these two IV iron preparations. |