Trial Review

Please note that the ANZCTR will be unattended on Friday 25th April due to the ANZAC Day public holiday. Submissions and updates will not be processed during that time.

The ANZCTR website is back online for trial registration and updates. We apologise for any inconvenience caused while the site was inactive.



Reset your password and enable multi-factor authentication (MFA)


For ANZCTR account holders: to help ensure the cyber safety of your account, you’ll need to reset your password and set-up multi-factor authentication (MFA) as per the instructions below.


  1. Go to the Login page, click ‘reset password’ and follow the instructions.
  2. Check your email for the link to set a new password.
  3. Create a new password that meets requirements. New passwords must include at least one lowercase letter, one uppercase letter, one number and one special character (e.g. !#$%&@).
  4. Return to the Login page and enter your new password. A verification code will be sent to your email.
  5. Check your email for the code and enter it on the Login page. If the code is entered incorrectly, you can re-enter the correct one or request a new one.

Learn more about MFA and its importance on the Australian Signals Directorate website.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12625000300471p
Ethics application status
Not yet submitted
Date submitted
2/04/2025
Date registered
15/04/2025
Date last updated
15/04/2025
Date data sharing statement initially provided
15/04/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
An Open-Label Study to Assess the Efficacy and Safety of Ferro-Lipo (Ferric Ammonium Citrate) in Patients with Iron Deficiency Anaemia
Scientific title
An Open-Label Study to Assess the Efficacy and Safety of Ferro-Lipo (Ferric Ammonium Citrate) in Patients with Iron Deficiency Anaemia
Secondary ID [1] 314092 0
GRCT-25-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Iron Deficiency Anaemia 336870 0
Condition category
Condition code
Blood 333342 333342 0 0
Anaemia

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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
Intervention code [1] 330669 0
Treatment: Drugs
Comparator / control treatment
No Control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 340919 0
Haemoglobin levels in patients with mild-to-moderate or moderate-to-severe iron deficiency anaemia over an 8-week treatment period.
Timepoint [1] 340919 0
Blood samples taken at baseline and at each follow up visit.
Secondary outcome [1] 445440 0
To assess the safety and tolerability of Ferro-Lipo in the study population. The safety and tolerability will be assessed as a composite secondary outcome.
Timepoint [1] 445440 0
At each study visit, physical examination and vital signs measurements (blood pressure, heart rate, temperature) will be performed. All AEs including SAEs will be assessed continuously via spontaneous reporting and documented in the patient diary from the time patient has signed informed consent form until the final follow-up phone call 14 days after end of treatment. The patient diary will be reviewed at each study visit.
Secondary outcome [2] 445441 0
Changes in serum ferritin from Baseline to Day 56 (Visit 6).
Timepoint [2] 445441 0
Blood samples taken at baseline and at each follow up visit (every 14 days).
Secondary outcome [3] 445442 0
Number of patients with a response to treatment from baseline to Day 56 (Visit 6).
Timepoint [3] 445442 0
Blood samples taken at baseline and Day 56 (Visit 6).
Secondary outcome [4] 445963 0
Changes in serum iron levels from Baseline to Day 56 (Visit 6).
Timepoint [4] 445963 0
Blood samples taken at baseline and at each follow up visit (every 14 days).
Secondary outcome [5] 445965 0
Changes in transferrin saturation from Baseline to Day 56 (Visit 6).
Timepoint [5] 445965 0
Blood samples taken at baseline and at each follow up visit (every 14 days).

Eligibility
Key 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%.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
12/06/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 26925 0
India
State/province [1] 26925 0
Maharashtra

Funding & Sponsors
Funding source category [1] 318600 0
Commercial sector/Industry
Name [1] 318600 0
AFT Pharmaceuticals Ltd
Country [1] 318600 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
AFT Pharmaceuticals Ltd
Address
Country
New Zealand
Secondary sponsor category [1] 321004 0
None
Name [1] 321004 0
Address [1] 321004 0
Country [1] 321004 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 317202 0
Humancare Independent Ethics Committee
Ethics committee address [1] 317202 0
Ethics committee country [1] 317202 0
India
Date submitted for ethics approval [1] 317202 0
17/04/2025
Approval date [1] 317202 0
Ethics approval number [1] 317202 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 140326 0
Dr Kapil Kanade
Address 140326 0
Office 1090 first floor, Marvel fuego, Amanora Park Town, Hadapsar, Pune, Maharashtra 411028
Country 140326 0
India
Phone 140326 0
+919697973636
Fax 140326 0
Email 140326 0
[email protected]
Contact person for public queries
Name 140327 0
Dr Laura Boddington
Address 140327 0
AFT Pharmaceuticals Ltd. Level 1, 129 Hurstmere Road, Takapuna, Auckland, New Zealand 0622
Country 140327 0
New Zealand
Phone 140327 0
+64 9 4880232
Fax 140327 0
Email 140327 0
[email protected]
Contact person for scientific queries
Name 140328 0
Dr Laura Boddington
Address 140328 0
AFT Pharmaceuticals Ltd. Level 1, 129 Hurstmere Road, Takapuna, Auckland, New Zealand 0622
Country 140328 0
New Zealand
Phone 140328 0
+64 9 4880232
Fax 140328 0
Email 140328 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.