| CTRI Number |
CTRI/2020/02/023173 [Registered on: 06/02/2020] Trial Registered Prospectively |
| Last Modified On: |
18/11/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Clinical study to evaluate the Efficacy and Safety of test drug Iron Dextran Injection 100 mg per 2 ml in the comparison to reference drug Iron CosmoFer injection in patients with Iron deficiency anemia who is not responding to oral iron therapy |
|
Scientific Title of Study
|
A Prospective, Interventional, Randomised, Double blind, Parallel Group, Comparative Clinical study to evaluate the Efficacy & Safety of test drug, Iron Dextran Injection 100 mg/ 2 ml in the comparison to reference drug, Iron CosmoFer (Iron Dextran Injection 100 mg/ 2 ml) injection in patients with Iron deficiency anemia who is not responding to oral iron therapy |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ICBio/CR/SPL/1126/103 version 01 dated 26 Nov 2019 |
Protocol Number |
| ICBio/CR/VLPL/0524/74 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Swetha J |
| Designation |
Rheumatologist |
| Affiliation |
Prakriya Hospitals |
| Address |
Tumkur road, Service road, Nagasandra,
Landmark: Near 8th Mile Signal
Nagasandra
Bangalore
KARNATAKA
560073
India |
| Phone |
9620488831 |
| Fax |
|
| Email |
drswetha.j31@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Harish S |
| Designation |
Director operations |
| Affiliation |
ICBio Clinical Research Pvt. Ltd |
| Address |
#16 & 18 ICBio Tower,
Yelahanka Main Road,
Chikkabettahalli, Vidyaranyapura,
Bangalore - 560 097, India
Bangalore
KARNATAKA
560097
India |
| Phone |
09900111997 |
| Fax |
|
| Email |
harish@icbiocro.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Harish S |
| Designation |
Director operations |
| Affiliation |
ICBio Clinical Research Pvt. Ltd |
| Address |
#16 & 18 ICBio Tower,
Yelahanka Main Road,
Chikkabettahalli, Vidyaranyapura,
Bangalore - 560 097, India
KARNATAKA
560097
India |
| Phone |
09900111997 |
| Fax |
|
| Email |
harish@icbiocro.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Swiss Parenterals Ltd |
| Address |
Ahmedabad
Gujarat India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Saikiran S |
People Tree Hospitals Clinical Research Center |
2, Tumkur Road, Goraguntepalya
(Next to Yeshwanthpura Metro Station),
Bangalore
Bangalore
KARNATAKA |
6361253143
drsaikiran@peopletreehospitals.com |
| Dr Swetha J |
Prakriya Hospitals |
Tumkur road Service road Nagasandra
Landmark Near 8th Mile Signal
Nagasandra
Bangalore 560073
Bangalore
KARNATAKA |
9620488831
drswetha.j31@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| People Tree Hospitals ethics committee |
Approved |
| People Tree Hospitals ethics committee |
Approved |
| People Tree Hospitals ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D50||Iron deficiency anemia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Iron CosmoFer injection |
Group 2 (Reference) Iron CosmoFer injection will be administered according to total iron deficit in alternative day on 4 to 5 different occasions within a 14 day period to achieve a total maximum cumulative dose of 1000 mg |
| Intervention |
Iron Dextran Injection |
Iron Dextran Injection 100 mg/ 2 ml will be administered according to total iron deficit in alternative day on 4 to 5different occasions within a 14 day period to achieve a total maximum cumulative dose of 1000 mg |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Male and female patients of age group above
18 years to 60 years.
2.Those willing to give written informed
consent and willing to adhere to protocol
requirements.
3.Chronic kidney disease patients who are
dependent or non dependent on dialysis with
iron deficiency anemia.
4.Iron deficiency anemia patients not
responding to oral iron therapy (i.e.
treatment refractory patients/ all patients
had been unresponsive or had had poor
responses to oral iron therapy (Hb increases < 2 g/dL using 160-200 mg/day of oral ferrous
sulphate over 4 weeks of treatment).
5.Iron Deficiency anemia Patients unable to
tolerate oral iron therapy because of
gastrointestinal side effects (ulcerative
colitis, IBD).
6.Pregnant ladies with haemoglobin level 5-9 g%
with diagnosed iron deficiency attending
antenatal clinic (if the treating physician
finds a need for parenteral iron therapy).
7.Patients with significant blood loss due to
any cause and diagnosed with iron deficiency
anemia.
8.Patients with normal folate and Vit B12
value.
|
|
| ExclusionCriteria |
| Details |
1. Patients with known hypersensitivity to iron
dextran or any component of the formulation.
2. Patients with Other causes of anemia other
than iron deficiency (vitamin B12 or folate
deficiency, etc.)
3.Patients with microcytic iron-overloading
disorder (thalassemia, sideroblastic anemia)
4.Chronic alcohol abuse (alcohol consumption
>20 g/day).
5.Presence of portal hypertension with
oesophageal varices.
6.Patients who have received erythropoietin,
intravenous iron therapy, or blood
transfusion 4 weeks prior to screening.
7.Chronic liver disease or increase of liver
enzymes (alanine aminotransferase ([ALT],
aspartate aminotransferase [AST]) >3 times
the upper limit of normal range.
8.Patients with positive serology at the time
of screening.
9.Significant cardiovascular disease, including
myocardial infarction within 12 months prior
to study inclusion, congestive heart failure
NYHA (New York Heart Association) grade III
or IV, or poorly controlled hypertension
according to the judgment of the
investigator.
10.Currently participating in another
investigational study or has participated in
an investigational study within 30 days prior
to randomization.
11.Has any other serious disease or condition
that would compromise subject safety or make
it difficult to successfully manage and
follow the subject according to the protocol.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvemental Changes in Haemoglobin (Hb), haematocrit (HCT), Ferritin, Iron (Fe), transferrin saturation (TSAT) and Total Iron binding capacity (TIBC) value from the screening to end of the treatment |
From the screening to end of the treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Improvemental Changes in Average size of RBCs Average amount of haemoglobin in RBCs , Haemoglobin concentration and Increased variation in value
2.Improvement on Changes in clinical signs and symptoms of iron deficiency anemia
3.Incidence of Adverse events and Serious Adverse Events throughout the trial duration.
|
From the screening to end of the treatment |
|
|
Target Sample Size
|
Total Sample Size="74"
Sample Size from India="74"
Final Enrollment numbers achieved (Total)= "62"
Final Enrollment numbers achieved (India)="62" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
10/02/2020 |
| Date of Study Completion (India) |
17/08/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="5" |
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
Modification(s)
|
A Prospective, Interventional, Randomised, Double blind, Parallel Group, Comparative Clinical study to evaluate the Efficacy & Safety of test drug, Iron Dextran Injection 100 mg/ 2 ml in the comparison to reference drug, Iron CosmoFer (Iron Dextran Injection 100 mg/ 2 ml) injection in patients with Iron deficiency anemia who is not responding to oral iron therapy
35 days (Depends on patients condition around 4 weeks treatment + Follow up after 7 ±3 days of completion of treatment)
Male or female patients with the age group from 18 to 60 years old having iron deficiency anemia who is not responding to oral iron therapy/ dialysis treated with Erythropoietin/ intolerance to oral iron preparations/ inflammatory gastrointestinal disorders etc.
62 subjects completed the study. |