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
- Conditions
- Health Condition 1: D50- Iron deficiency anemia
- Registration Number
- CTRI/2020/02/023173
- Lead Sponsor
- Swiss Parenterals Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 62
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 treatmentTimepoint: From the screening to end of the treatment
- Secondary Outcome Measures
Name Time Method 1.Improvemental Changes in Average size of RBCs Average amount of haemoglobin in RBCs , Haemoglobin concentration and Increased variation in value <br/ ><br>2.Improvement on Changes in clinical signs and symptoms of iron deficiency anemia <br/ ><br>3.Incidence of Adverse events and Serious Adverse Events throughout the trial duration. <br/ ><br>Timepoint: From the screening to end of the treatment