Health Condition 1: D509- Iron deficiency anemia, unspecified
Conditions
Interventions
Intervention1: Ferric Carboxymaltose Injection 750mg/15ml (50mg/ml): Dose: 750mg/15ml,
Frequency: Single dose,
Route of administration: Slow IV Injection,
Duration: 7.5mins.
Control Intervention1: INJ
Sponsors
RK Pharma Inc
Eligibility
Inclusion criteria
Inclusion criteria: 1) Patient or LAR willing to provide informed consent to participate. 2)Male or non-pregnant, non-lactating females aged 18-65 years (inclusive). 3) Patients diagnosed with iron deficiency anemia, for whom oral supplementation alone is not adequate/not appropriate or with non-dialysis dependent chronic renal disease (as defined by either i)GFR is less than 60ml/min/1.73m2 on screening (As calculated by MDRD), or ii)GFR is lessthan90ml/min/1.73m2 during screening and at least 1 marker of kidney damage based on medical history within 3 months of screening. Markers of kidney disease may include: albuminuria (ACR less than 3mg/mmol), hematuria, and electrolyte abnormalities due to tubular disorders, renal histological abnormalities, structural abnormalities detected by imaging or a history of kidney transplantation. 4) Patients considered to be suitable for treatment with Ferric Carboxymaltose Injection based on Investigator judgement. 5) Patients with body weight more than or equals to 50 kg at screening and check in, with BMI of 18.50 to 30.00 kg/m2 at the time of screening. 6) Patients with hemoglobin levels of more than or equals to 9.0 g/dL and less than 12g/dL at screening. 7) Patients with Iron status evaluation at screening defined as: Serum Ferritin of less than or equals to 100 ng/mL (or less than or equal to 300ng/mL when TSAT is less than or equal to 30%). 8)Patients with normal Serum Phosphate level 3.4 to 4.5 mg/dl (1.12 to 1.45 mmol/L). 9) Patients with adequate hematopoietic and liver function at screening, defined as iii)ANC more than or equal to 1500/mm3, Platelet count more than or equal to 100,000/mm3. iv)AST and ALT less than or equal to 3 times ULN, Alkaline phosphatase leass than or equal to 2.5 times ULN, Bilirubin less than or equal to 1.5 times ULN. 10) Patient agrees to comply with the study procedures and requirements of the study. 11)Male Patients willing to follow approved birth control methods (a double barrier method) for the duration of the study as judged by the investigator(s), such as condom with spermicide, condom with diaphragm, or abstinence, vasectomized. Subjects should not donate sperm during this time. 12) Female patients should have been postmenopausal for at least 1 year, or surgically sterilized via hysterectomy, bilateral tubal ligation, bilateral oophorectomy; or practicing an acceptable form of birth control (defined as the use of an intrauterine device; a barrier method, like condom, with spermicide; any form of hormonal contraceptives; or abstinence from sexual intercourse) starting 60 days prior to dosing in case of women with a childbearing potential and prepared to continue for at least 30 days following the last treatment. 13) Each female study participant should be negative serum pregnancy test at screening and urine pregnancy test in check-in.
Exclusion criteria
Exclusion criteria: 1)Patients with known hypersensitivity to ferric carboxymaltose, or any of its inactive components, excipients, or similar product or any other iron preparation. 2)Patients who have received any of the following medications in recent past: v)Parenteral iron therapy within the last 6 months prior to randomization. vi)Oral iron therapy within 4 weeks prior to randomization. Erythropoiesis stimulating agents within 3 months prior to randomization. vii)Concomitant medications that may affect the PK results based on investigators discretion. 3) Patients with clinically significant uncontrolled blood pressure or labile hypertension (systolic blood pressure more than 150 mm/Hg and diastolic blood pressure more than 100 mm/Hg. 4) Patients with Stage 5 Chronic Kidney Disease (CKD) [eGFR less than 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 with low serum phosphate levels (i.e.; below 3.4 mg/dl). 14) Patients with clinically significant abnormal blood pressure (Systolic blood pressure below 100 mm/Hg and above 150 mm/Hg; Diastolic blood pressure below 60 mm/Hg and above 100 mm/Hg). 15) Patients who participated in another clinical trial within 60 days prior to randomization. 16) 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). 17) 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. 18) Female patients who are pregnant or planning (women with childbearing potent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1)To determine the bioequivalence for Ferric Carboxymaltose Injection 750 mg/15mL (50 mg/mL) of RK Pharma Inc. with INJECTAFER(Ferric Carboxymaltose Injectionn750mg/15mL [50 mg/mL]) of American Regent, Inc. Shirley, NY 11967, following a single intravenous dose of 750mg in adult human patients with iron deficiency anemia. 2)To assess the safety and tolerability of Ferric Carboxymaltose Injection 750mg iron /15 mL by reported adverse events, laboratory, clinical investigations and vital signs.Timepoint: Blood samples will be collected at various time points from Day-0 to Day-2 in 4ml plain vacutainers. | — |
Secondary
| Measure | Time frame |
|---|---|
| NILTimepoint: NIL | — |
Countries
India
Contacts
Public ContactSriram Eswaran
Actimus Biosciences Pvt Ltd
Outcome results
None listed