Pharmacokinetic Study of Ferric Carboxymaltose injection in Iron deficiency anemia patients.
- Conditions
- Health Condition 1: D509- Iron deficiency anemia, unspecified
- Registration Number
- CTRI/2021/07/034733
- Lead Sponsor
- Dr Sanjeev Hegde
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
1. Patients diagnosed with iron deficiency anemia, for whom oral supplementation alone is not adequate/appropriate or with non-dialysis dependent chronic renal disease (as defined by either (i) GFR <60 mL/min/1.73m2 on screening (as calculated by MDRD, or (ii) GFR <90 mL/min/1.73m2 during screening & at least 1 marker of kidney damage based on medical history within 3 months of screening).
2. Age: Between the ages of 18 and 65 years.
3. Sex: Males and/or non-pregnant, non-lactating females..
4. Weight: Each patient is required to weigh at least 50 kg (110 lbs) and have a Body Mass Index (BMI) value less than or equal to 30.0 kg/m2 but greater than or equal to 18.5 kg/m2.
5. Smoking Status: Non-smokers preferred, however, up to moderate smokers are permitted.
6. Able to understand and sign the written Informed Consent Form.
7. Willing to follow the protocol requirements and comply with protocol restrictions.
All patients should be judged by the Principal Investigator or Medical Sub-Investigator as normal and relatively healthy (excluding iron-deficiency anemia) during a pre-study medical evaluation
1. Institutionalized patients.
2. Social Habits:
a. Ingestion of any alcoholic beverage, caffeine- or xanthine-containing food or beverage, any vitamins or herbal products prior to the initial administration of study medication.
b History of drug and/or alcohol abuse within one year of randomization.
3. Medications:
a. Parenteral iron therapy within the last 6 months prior to the initial dose of study medication.
b. Oral iron therapy within 14 days prior to randomization.
c. Erythropoiesis stimulating agents within 3 months prior to the initial dose of study medication.
d. Diseases:
History of any significant cardiovascular, hepatic, renal, pulmonary, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, psychological, genitourinary, musculoskeletal disease or malignancies unless deemed clinically non-significant by the Principal Investigator or Medical Sub-Investigator.
4. Patients diagnosed with iron deficiency anaemia for whom oral supplementation alone is not adequate/appropriate.
5. Patients with Stage 5 Chronic Kidney Disease (CKD) [eGFR < 15 mL/min/1.73 m2 estimated using the MDRD equation] or undergoing dialysis for treatment of CKD or under consideration for dialysis during study period..
6. 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.
7. Intolerance to venipuncture.
8. Donation or loss of blood or plasma: 50 mL or more within 60 days prior to the administration of study medication.
9. Patients who have received an investigational drug within 60 days prior to the administration of study medication.
10. Any food allergy, intolerance, restriction or special diet that, in the opinion of the Principal Investigator or Medical Sub-Investigator, could contraindicate the patientââ?¬•s participation in this study.
11. Patients with known hypersensitivity to ferric carboxymaltose, excipients, or similar product or any other iron preparation.
12. Subject has clinical signs and symptoms consistent with COVID-19, within the last 28 days prior to screening or on admission.
Subject who had severe course of COVID-19 (extracorporeal membrane oxygenation (ECMO), mechanically ventilated).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method