CTRI/2024/11/076426 [Registered on: 08/11/2024] Trial Registered Prospectively
Last Modified On:
03/12/2024
Post Graduate Thesis
No
Type of Trial
BA/BE
Type of Study
Study Design
Randomized, Parallel Group Trial
Public Title of Study
Study of Ferric Carboxymaltose Intravenous Injection (750 mg Iron/15 mL) with that of Injectafer® [Ferric Carboxymaltose Injection (750 mg Iron/15 mL)] Under Fasting Condition in Adult Patients with Iron Deficiency Anaemia
Scientific Title of Study
A Multicentre, Open Label, Randomized, Single-Dose, Two-Treatment, Parallel Arm Bioequivalence Study of Ferric Carboxymaltose Intravenous Injection (750 mg Iron/15 mL) of Dr. Reddy’s Laboratories Ltd, India, with that of Injectafer® [Ferric Carboxymaltose Injection (750 mg Iron/15 mL)] of American Regent Inc., USA Under Fasting Condition in Adult Patients with Iron Deficiency Anaemia, for whom Oral Iron Supplementation Alone was Not Adequate or is Not Appropriate
(1) ICD-10 Condition: E00-E89||Endocrine, nutritional and metabolic diseases,
Intervention / Comparator Agent
Type
Name
Details
Intervention
Ferric carboxymaltose
Dosage form: Single dose vial for injection, Strength: 750 mg Iron/15 ml, Frequency: Two doses separated by at least 7 days, Route of administration: Intravenous injection
Comparator Agent
Ferric carboxymaltose (Injectafer®)
Dosage form: Single dose vial for injection, Strength: 750 mg Iron/15 ml, Frequency: Two doses separated by at least 7 days, Route of administration: Intravenous injection
Inclusion Criteria
Age From
18.00 Year(s)
Age To
65.00 Year(s)
Gender
Both
Details
1. Willing to provide written informed consent indicating that they understand the study requirements
and are willing to participate in the study.
2. Male and female patients aged between 18 and 65 years (including both).
3. Adult patients with iron deficiency anaemia, for whom oral supplementation alone was not adequate
or is not appropriate in the opinion of the Investigator.
4. Patient’s weight within clinically acceptable normal range with minimum of 50 kg body weight at
screening visit.
5. Haemoglobin value ranging between greater than 7 and less than 12 g per dL at screening
6. Ferritin ≤ 100 ng/mL or Ferritin less than or equal to 300 ng per mL when TSAT is ≤30% at screening
7. For Female Patients: Female patients of childbearing potential must have negative Serum β-hCG (pregnancy test) at
screening and Urine Pregnancy test on Day 0 as well as be willing to use a reliable means of contrace ption (other than hormonal contraceptives) e.g., barrier method (diaphragm, condom, etc.)
or abstinence for the duration of the study or Surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the patient) or Postmenopausal for at least one year from the last menstrual date.
ExclusionCriteria
Details
1. Ongoing pregnancy or lactation for females
2. Known hypersensitivity to IMP, excipients, or other iron product
3. History of: Anaemia not caused by iron deficiency (e.g., aplastic, megaloblastic or haemolytic anaemia, sideroblastic anaemia) or related to acute or ongoing, haemoglobinopathies, rheumatic and other chronic diseases like CKD, autoimmune diseases, malignancies, bone marrow diseases, enzyme defects and drug induced anaemia.
Any ongoing acute or chronic infection at screening.
Any chronic disorder or severe disease which, in the opinion of the investigator, might jeopardize
patient’s safety or compliance with the protocol.
Haemochromatosis or other iron storage disorders.
Alcoholism or drug abuse, or severe emotional, behavioural or psychiatric problems within 6 months
prior to screening, who may not be able to adequately comply with the requirements of the study.
Any active malignancy within 5 years prior to screening.
Clinically significant hypertension or labile hypertension.
4. Known:
Significant comorbidities like major cardiovascular disease [including myocardial infarction within
6 months prior to study inclusion, congestive heart failure (New York Heart Association III or IV)
or poorly controlled hypertension]; uncontrolled endocrinological or metabolic disorders;
malignancy, active renal disease, active liver disease, active peptic ulcer, asthma or rheumatoid
arthritis.
HIV positive or Acquired Immunodeficiency Syndrome (AIDS) related illness, or HIV
seropositivity at screening.
Presence of hepatitis B surface antigen (HBsAg) at screening or within 3 months prior to first dose
of investigational intervention.
Positive hepatitis C antibody test result at screening or within 3 months prior to starting
investigational intervention.
NOTE: Participants with positive hepatitis C antibody due to prior resolved disease can be enrolled
only if a confirmatory negative hepatitis C RNA test is obtained.
Bleeding disorders; acute bleeding or recently documented haemorrhage or recent blood loss leading
to hemodynamic instability within 3 months prior to screening.
5. Receipt of:
Medications that may affect PK results within 14 days before screening (Please refer Section 5.1.11).
Oral iron supplementation within 15 days prior to screening.
Blood transfusion within 3 months prior to screening, or anticipated need for a blood transfusion
during the study.
Parenteral iron therapy within the last 3-6 months prior to screening.
Erythropoietin / Erythroid Stimulating Agent treatment within 6 months prior to screening
6. Donation of blood (1 unit or 350 mL) or receipt of an investigational medicinal product or participation
in a drug research study within 90 days prior to receiving the first dose of IMP.
7. Inadequate venous access for PK sampling as judged by investigator.
8. Requirement of any planned procedure or hospitalization for pre-existing conditions during the study
period.
Total Sample Size="180" Sample Size from India="180" 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
N/A
Date of First Enrollment (India)
10/11/2024
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="0" Months="3" 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 - NO
Brief Summary
The primary objective of this study is to assess the bioequivalence in adult patients with iron deficiency anaemia, for whom oral iron supplementation alone was not adequate or is not appropriate, under fasting condition