CTRI/2022/03/041253 [Registered on: 22/03/2022] Trial Registered Prospectively
Last Modified On:
13/06/2023
Post Graduate Thesis
No
Type of Trial
BA/BE
Type of Study
Study Design
Randomized, Parallel Group, Active Controlled Trial
Public Title of Study
Bioequivalence study of Ferric Carboxymaltose Injection 1000 mg of RK Pharma Inc. with Ferinject 1000 mg in adult human patients with iron deficiency anemia.
Ethics Committee of Ishwar Institute of Health Care
Approved
Institute of Human Ethics Committee
Approved
Institutional Ethics Committe Dr. M K Shah Medical College and Research Centre
Approved
Institutional Ethics Committe of KLE Academy of Higher Education and Research
Approved
Institutional Ethics Committee
Approved
Institutional Ethics Committee Induss Hospital
Approved
Lifepoint Research Ethics Committee
Approved
Manoj ENT Speciality- Institutional Ethics Committee
Approved
O & P Institutional Ethics Committee
Approved
Parth Institutional Ethics Committee
Approved
Parth Institutional Ethics Committee
Approved
Vijaya Institutional Ethics committee
Approved
Regulatory Clearance Status from DCGI
Status
Approved/Obtained
Health Condition / Problems Studied
Health Type
Condition
Patients
(1) ICD-10 Condition: D631||Anemia in chronic kidney disease,
Intervention / Comparator Agent
Type
Name
Details
Comparator Agent
Ferinject Injection 1000 mg Iron /20mL (50 mg/mL)
Single dose of Ferinject injection 1000 mg in supine position as a slow intravenous injection over a period of 10 minutes (at the rate of approximately 100 mg [2 mL] per minute) using a calibrated syringe pump.
Intervention
Ferric Carboxymaltose Injection 1000 mg Iron /20mL (50 mg/mL) of RK Pharma Inc
Single dose of Ferric Carboxymaltose Injection 1000 mg in supine position as a slow intravenous injection over a period of 10 minutes (at the rate of approximately 100 mg [2 mL] per minute) using a calibrated syringe pump.
Inclusion Criteria
Age From
18.00 Year(s)
Age To
65.00 Year(s)
Gender
Both
Details
1. Patients with known hypersensitivity to ferric carboxymaltose, excipients, or similar product or any other iron preparation
2. Patients who have received any of the following medications in recent past:
(i) Parenteral iron therapy within the last 6 months prior to randomization
(ii) Oral iron therapy within 4 weeks prior to randomization
(iii) Erythropoiesis stimulating agents within 3 months prior to randomization
(iv) Concomitant medications that may affect the PK results based on
investigators discretion
3. Patients with clinically significant or labile hypertension.
4. Patients with Stage 5 Chronic Kidney Disease (CKD) [eGFR < 15 mL/min/1.73 m2] or undergoing dialysis for treatment of CKD or under consideration for dialysis during study period.
5. Patients considered to be anemic due to other aetiology such as severe malabsorption
syndrome, immunosuppressant use, aplastic anemia, megaloblastic or haemolytic anaemia, untreated Vitamin B12 or folate deficiency or hemoglobinopathy etc.
6. Patients with hemochromatosis or other iron storage disorders.
7. Patients with blood loss leading to hemodynamic instability.
8. Patients who had major surgery or invasive intervention within 4 weeks prior to
screening, organ transplant within 6 months prior to screening, or have a surgery or
intervention planned during the course of the study.
9. Patients who received whole blood transfusion or red blood cell transfusion or
donated blood (1 unit or 350 mL) within 90 days prior to randomization.
10. Patients with history of alcohol abuse or drug abuse or drug dependence within last 1 year from screening.
11. Patients who have HIV or positive hepatitis screen including hepatitis B surface
antigen, HCV antibodies and RPR.
12. Patients with positive urine alcohol test and drugs of abuse in urine during screening and at check-in.
13. Patients who participated in another clinical trial within 60 days prior to
randomization.
14. Patients with known active malignancy (i.e., clinical evidence of current malignancy or not in stable remission for at least 5 years since completion of last treatment with exception of basal cell or squamous cell carcinoma of the skin, and cervical intraepithelial neoplasia).
15. Patients with significant comorbidities such as congestive heart failure, asthma, decompensated liver cirrhosis, eczema or atopic allergy, acute/chronic infection of any type, systemic lupus erythematous, rheumatoid or inflammatory arthritis, inflammatory bowel disease, rheumatic disease or any other condition, that in theinvestigator’s judgement, might increase the risk to the patient or decrease the chance of obtaining satisfactory PK data.
16. Female patients who are pregnant or planning (women with childbearing potential) to become pregnant during the study.
Study participants meeting the inclusion and exclusion criteria will be verified by the investigators as per source documents duly authenticated by them, reflecting clinical judgment as and when required
ExclusionCriteria
Details
1. Patients with known hypersensitivity to ferric carboxymaltose, excipients, or similar product or any other iron preparation
2. Patients who have received any of the following medications in recent past:
(i) Parenteral iron therapy within the last 6 months prior to randomization
(ii) Oral iron therapy within 4 weeks prior to randomization
(iii) Erythropoiesis stimulating agents within 3 months prior to randomization
(iv) Concomitant medications that may affect the PK results based on
investigators discretion
3. Patients with clinically significant or labile hypertension.
4. Patients with Stage 5 Chronic Kidney Disease (CKD) [eGFR < 15 mL/min/1.73 m2] or undergoing dialysis for treatment of CKD or under consideration for dialysis during study period.
5. Patients considered to be anemic due to other aetiology such as severe malabsorption
syndrome, immunosuppressant use, aplastic anemia, megaloblastic or haemolytic anaemia, untreated Vitamin B12 or folate deficiency or hemoglobinopathy etc.
6. Patients with hemochromatosis or other iron storage disorders.
7. Patients with blood loss leading to hemodynamic instability.
8. Patients who had major surgery or invasive intervention within 4 weeks prior to
screening, organ transplant within 6 months prior to screening, or have a surgery or
intervention planned during the course of the study.
9. Patients who received whole blood transfusion or red blood cell transfusion or
donated blood (1 unit or 350 mL) within 90 days prior to randomization.
10. Patients with history of alcohol abuse or drug abuse or drug dependence within last 1 year from screening.
11. Patients who have HIV or positive hepatitis screen including hepatitis B surface
antigen, HCV antibodies and RPR.
12. Patients with positive urine alcohol test and drugs of abuse in urine during screening and at check-in.
13. Patients who participated in another clinical trial within 60 days prior to
randomization.
14. Patients with known active malignancy (i.e., clinical evidence of current malignancy or not in stable remission for at least 5 years since completion of last treatment with exception of basal cell or squamous cell carcinoma of the skin, and cervical intraepithelial neoplasia).
15. Patients with significant comorbidities such as congestive heart failure, asthma, decompensated liver cirrhosis, eczema or atopic allergy, acute/chronic infection of any type, systemic lupus erythematous, rheumatoid or inflammatory arthritis, inflammatory bowel disease, rheumatic disease or any other condition, that in the investigator’s judgement, might increase the risk to the patient or decrease the chance of obtaining satisfactory PK data.
16. Female patients who are pregnant or planning (women with childbearing potential) to become pregnant during the study.
Study participants meeting the inclusion and exclusion criteria will be verified by the investigators as per source documents duly authenticated by them, reflecting clinical judgment as and when required
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Not Applicable
Blinding/Masking
Not Applicable
Primary Outcome
Outcome
TimePoints
To determine the bioequivalence Ferric Carboxymaltose Injection 1000 mg Iron /20mL (50 mg/mL) of RK Pharma Inc. with Ferinject® ɛisencarboxymaltose 50 mg Eisen/ml.
From baseline to End of Study
Secondary Outcome
Outcome
TimePoints
To assess the safety and tolerability of Ferric Carboxymaltose Injection 1000 mg iron / 20 mL by reported adverse events, laboratory, clinical investigations and vital signs.
From Baseline to end of study
Target Sample Size
Total Sample Size="196" Sample Size from India="196" Final Enrollment numbers achieved (Total)= "0" Final Enrollment numbers achieved (India)="196"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
In this study adult patients with iron deficiency anemia, for whom oral supplementation alone is not adequate or is not appropriate or patients with non-dialysis dependent chronic renal disease will be enrolled. patients will receive either test product or reference product through the IWRS. A total of 27 blood samples (2 x 5 mL each) will be collected. Safety will be evaluated based on general and systemic examination, Vital signs, ECG, Clinical laboratory parameters from baseline and at end of the study.