None listed
Conditions
Brief summary
This study is designed to evaluate the efficacy and safety of Ferro-Lipo (Ferric Ammonium Citrate) in patients with mild to moderate or moderate to severe iron deficiency anaemia. This study will include 60 both male and female patients aged 18 years and older diagnosed with iron deficiency anaemia. The study aims to demonstrate that Ferro-Lipo improves the iron status in patients with mild-to-moderate or moderate-to-severe iron deficiency anaemia over an 8-week period.
Interventions
Test Product: Ferric Ammonium Citrate 93.5 mg (equivalent to 20 mg of elemental iron per sachet) administered 1 sachet daily for 8 weeks.
The dose should be taken during or immediately after a meal dissolved in 1 glass of cold still water (Approx. 100 ml) to improve tolerance.
A Site staff will check the dosing diary during every visit scheduled every 14 days and ensure the administration status of medicinal products.
The Site staff will check the medicinal product administration status every d
Test Product: Ferric Ammonium Citrate 93.5 mg (equivalent to 20 mg of elemental iron per sachet) administered 1 sachet daily for 8 weeks. The dose should be taken during or immediately after a meal dissolved in 1 glass of cold still water (Approx. 100 ml) to improve tolerance. A Site staff will check the dosing diary during every visit scheduled every 14 days and ensure the administration status of medicinal products. The Site staff will check the medicinal product administration status every day by calling the patient
Sponsors
AFT Pharmaceuticals Ltd
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1) Male and Female patients aged 18 years and above with a diagnosis of iron deficiency anaemia on the screening day and willing to provide written informed consent/assent form to participate in the study. 2) Diagnosed iron deficiency anaemia (mild-to-moderate or moderate-to-severe) based on 2 criteria: a. Haemoglobin level to diagnose anaemia(g/dl). For Non-pregnant women (18 yearsof age and above): No Anaemia: =12 Mild: 11–11.9 Moderate: 8–10.9 Severe: <8 For men: No anaemia: =13 Mild: 11–12.9 Moderate: 8–10.9 Severe: <8 b. Serum Ferritin Level: -Mild-to-Moderate IDA: Serum ferritin <30 µg/L -Moderate-to-Severe IDA: Serum ferritin <15 µg/L 3) Patients must be willing and able to understand and comply with the requirements of the protocol, including attendance at the required study visits. 4) Female patients of childbearing potential must have a negative urine pregnancy report and should follow abstinence or use contraceptive methods with a failure rate of < 1%.
Exclusion criteria
1. Administration of any iron-containing drugs during the last 3 months. 2. History of erythropoietin drug administration. 3. Hypersensitivity to iron therapy (both Oral and/or IV administration) and other components of the study drugs. 4. Hormone therapy (including the use of androgens/anabolic steroids) or administration of drugs that inhibit blood formation, less than 3 months before the start of the study. 5. History of severe allergic reactions or drug intolerance. 6. Fructose intolerance, glucose-galactose malabsorption syndrome, and sucrase-isomaltase deficiency. 7. Failure of iron therapy for iron-deficiency anaemia in a patient's past medical history. 8. Heme metabolism disorders (e.g., sideroachrestic anaemia, lead anaemia, thalassemia). 9. Iron overload including hemochromatosis and hemosiderosis. 10. Other causes of anaemia, apart from iron deficiency, including: a. Haemolysis (determined as per analysis results at screening, or as per anamnestic data). b. Vitamin B12 and folic acid deficiency (as per the screening data). c. Chronic kidney disease (creatinine clearance at screening is below 90 ml/min (based on Cockcroft-Gault Formula)). d. Systemic connective tissue diseases, chronic infectious diseases requiring regular therapy (as per the past medical history), and other conditions which may, in the investigator's opinion, be accompanied by anaemia of chronic diseases. 11. Dysfunction of the thyroid gland (based on the data obtained at screening). 12. Laboratory and clinical signs of an active inflammatory process for 10 days before screening. 13. AST, ALT, and total bilirubin levels exceeding the upper limit of normal range by 1.5 times and more. 14. Clinically apparent hypothyroidism, in the investigator's opinion. 15. Malignant diseases, including blood and lymphoid tissue disorders (leukaemia, Hodgkin disease, myelodysplastic syndrome, myeloma, etc.) at screening or in the past medical history, provided that the remission was less than 5 years before screening. 16. Signs of bone marrow aplasia at screening or history of bone marrow aplasia. 17. The necessity of parenteral iron therapy, i.e., the following cases: a. Impaired absorption in case of intestinal pathology (enteritis, celiac disease, malabsorption, small intestinal resection, stomach resection, including the duodenum). b. Exacerbation of gastric or duodenal ulcer. c. The necessity of quick iron saturation, e.g., in patients with iron deficiency anaemia with upcoming surgery. d. Continuous vast blood loss and other causes, at the discretion of the investigator. e. Sickle cell anaemia 18. Known presence of an active infection caused by Helicobacter pylori. In case of the presence of Helicobacter pylori, a patient may be enrolled after eradicative therapy. 19. Concomitant diseases and conditions, which, in the investigator's opinion, pose a risk to a patient's safety in case of his/her participation in the study, or able to affect the safety data analysis in case of exacerbation of this disease/condition during the study, including: a. Myocardial infarction or stroke within 6 months before screening. b. Unstable angina. c. Severe arrhythmia, not controlled by drug therapy. d. Decompensated diabetes mellitus. e. Nephrological disorders. 20. Other significant diseases, at the discretion of the investigator. 21. Pregnant or lactating women, or women intending to become pregnant during the study.
Outcome results
None listed