Bioequivalence study of Ferric Carboxymaltose Injection 1000 mg of RK Pharma Inc. with Ferinject 1000 mg in adult human patients with iron deficiency anemia.
- Conditions
- Health Condition 1: D631- Anemia in chronic kidney disease
- Registration Number
- CTRI/2022/03/041253
- Lead Sponsor
- RK Pharma Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 196
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 theinvestigatorâ??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
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 investigatorâ??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
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To determine the bioequivalence Ferric Carboxymaltose Injection 1000 mg Iron /20mL (50 mg/mL) of RK Pharma Inc. with Ferinject® É?isencarboxymaltose 50 mg Eisen/ml.Timepoint: From baseline to End of Study
- Secondary Outcome Measures
Name Time Method 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.Timepoint: From Baseline to end of study