Health Condition 1: D509- Iron deficiency anemia, unspecified
Conditions
Interventions
Intervention1: Ferric carboxymaltose injection: (750 mg
Iron/15 mL) of Dr. Reddyâ??s Laboratories Ltd, India
Control Intervention1: Injectafer®: [Ferric carboxymaltose injection (750 mg
Iron/15 mL)]
Sponsors
Dr Reddys Laboratories Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 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. Patients diagnosed with iron deficiency anaemia, who have intolerance to oral iron or have had unsatisfactory response to oral iron in the opinion of the Investigator. 4. Patientâ??s weight within clinically acceptable normal range according to normal values for body mass index 18.50 to 30 kg/m2 (both inclusive) with minimum of 50 kg body weight. 5. Haemoglobin value ranging between morethan 7 and lessthan 12 g/dL at screening. 6. Ferritin lessthan or equal to 100 ng/mL or less than or equal to 300 ng/mL when TSAT is lessthan or equal to30% at screening 7. For Female Patients: - Female patients of childbearing potential must have negative Serum Beta-hCG (pregnancy test) at screening and Urine Pregnancy test on Day 0 as well as be willing to use a reliable means of contraception (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
Exclusion criteria
Exclusion criteria: 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 patientâ??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. 4. Clinically significant hypertension (as per JNC 8 recommendations) or clinical diagnosis of labile hypertension, as per investigators judgement. 5. 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. - Active or chronic hepatitis B or hepatitis C infection, or Hepatitis B and Hepatitis C seropositivity at screening, if not related to vaccination. - Bleeding disorders; acute bleeding or recently documented haemorrhage or recent blood loss leading to hemodynamic instability within 3 months prior to screening. 6. Receipt of: - Medications that may affect PK results within 14 days before enrolment. - Oral iron supplementation within the past 1 month 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 6 months prior to screening. - Erythropoietin / Erythroid Stimulating Agent treatment within 6 months prior to screening. 7. 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. 8. Inadequate venous access for PK sampling as judged by investigator. 9. Requirement of any planned procedure or hospitalization for pre-existing conditions during the study period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax, AUC0-t, AUC0-inf for Total Iron and Trasferrine bound IronTimepoint: Blood samples will be collected at various time points over Day 1 to Day 6 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Tmax, AUC_% Extrap_obs, t1/2, and lambdaz for Total Iron and Trasferrine bound Iron 2. TEAEs 3. Clinically significant changes in the vital signs,physical examination, laboratory evaluations and electrocardiogram. Timepoint: 1. blood samples will be collected at various time points over Day 1 to Day 6 2. over entire study duration 3. over entire study duration | — |
Countries
India
Contacts
Public ContactMr Praveen kumar Parepally
Navitas life sciences Pvt Ltd
Outcome results
None listed