Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000147583p
Ethics application status
Not yet submitted
Date submitted
1/02/2024
Date registered
15/02/2024
Date last updated
15/02/2024
Date data sharing statement initially provided
15/02/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
A Therapeutic Equivalence Study comparing Iron (III) Hydroxide Polymaltose 100mg Hard Gelatin Capsules to Maltofer® 370 mg Tablets (100mg iron as iron polymaltose) in the treatment of Iron Deficiency Anaemia in Pregnant and Non-Pregnant Women, and Men
Scientific title
A Randomized, Double-Blind, Multicentre, Parallel, Two-Arm, Therapeutic Equivalence Study comparing Iron (III) Hydroxide Polymaltose 100mg Hard Gelatin Capsules to Maltofer® 370 mg Tablets (100mg iron as iron polymaltose) in the treatment of Iron Deficiency Anaemia in Pregnant and Non-Pregnant Women, and Men
Secondary ID [1] 311454 0
GRCT-23-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Iron Deficiency Anaemia 332750 0
Condition category
Condition code
Blood 329471 329471 0 0
Anaemia

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Test Product: Iron (III) Hydroxide Polymaltose 100mg Hard Gelatin Capsules. To be taken orally once daily for 8 consecutive weeks (56 days), during or right after a meal.

A Site staff will check the dosing diary during every visit 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] 327901 0
Treatment: Drugs
Comparator / control treatment
Maltofer® 370 mg Tablets (100mg iron as iron polymaltose). To be taken orally once daily for 8 consecutive weeks (56 days), during or right after a meal.

A Site staff will check the dosing diary during every visit and ensure the administration status of medicinal products.
The Site staff will check the medicinal product administration status every day by calling the patient.
Control group
Active

Outcomes
Primary outcome [1] 337282 0
Change in blood haemoglobin level from baseline to week 8.
Timepoint [1] 337282 0
Blood samples will be taken at Screening and Baseline (Day 0), Day 14 (Week 2), Day 28 (Week 4), Day 42 (Week 6) and Day 56 (Week 8/EOT/End of Study)
Secondary outcome [1] 431314 0
Change in ferritin from baseline to Weeks 0, 2, 4, 6 and 8
Timepoint [1] 431314 0
Blood samples will be taken at Screening and Baseline (Day 0), Day 14 (Week 2), Day 28 (Week 4), Day 42 (Week 6) and Day 56 (Week 8/EOT/End of Study)
Secondary outcome [2] 431315 0
Number of patients with a response to the therapy from baseline to week 8
Timepoint [2] 431315 0
Blood samples taken at Baseline and Week 8
Secondary outcome [3] 431316 0
The incidence of adverse events (AEs), serious adverse events (SAEs), and laboratory investigations throughout the study.
Timepoint [3] 431316 0
Participants will record any adverse reactions in their patient diary throughout the duration of the trial from baseline (Day 0) to Day 56 (Week 8/EOT/End of Study). The patient diary will be reviewed at each clinic visit at Day 14 (Week 2), Day 28 (Week 4), Day 42 (Week 6) and Day 56 (Week 8/EOT/End of Study).

Vital signs (Heart rate, blood pressure and body temperature), ECG, Physical Examination and Blood samples will be taken at Screening and Baseline (Day 0), Day 14 (Week 2), Day 28 (Week 4), Day 42 (Week 6) and Day 56 (Week 8/EOT/End of Study).

Urinalysis will be conducted at Screening/Baseline visit and at Day 56 (Week 8/EOT/End of Study).
Secondary outcome [4] 431760 0
Change in Transferrin from baseline to Weeks 0, 2, 4, 6 and 8
Timepoint [4] 431760 0
Blood samples will be taken at Screening and Baseline (Day 0), Day 14 (Week 2), Day 28 (Week 4), Day 42 (Week 6) and Day 56 (Week 8/EOT/End of Study)
Secondary outcome [5] 431761 0
Change in Percent Transferrin saturation from baseline to Weeks 0, 2, 4, 6 and 8
Timepoint [5] 431761 0
Blood samples will be taken at Screening and Baseline (Day 0), Day 14 (Week 2), Day 28 (Week 4), Day 42 (Week 6) and Day 56 (Week 8/EOT/End of Study)
Secondary outcome [6] 431762 0
Change in serum iron from baseline to Weeks 0, 2, 4, 6 and 8
Timepoint [6] 431762 0
Blood samples will be taken at Screening and Baseline (Day 0), Day 14 (Week 2), Day 28 (Week 4), Day 42 (Week 6) and Day 56 (Week 8/EOT/End of Study)

Eligibility
Key inclusion criteria
• Adult male patients, Pregnant and non-pregnant 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.
• Diagnosed iron deficiency anaemia based on 2 criteria:
•a. Haemoglobin level below 110 g/L but should be above 60 g/L.
•b. Serum ferritin level below 30 µg/L.
• Patients must be willing and able to understand and comply with the requirements of the protocol, including attendance at the required study visits.
• For pregnant patients: Females in their first and second trimesters of pregnancy will be considered.
• For non-pregnant patients: Females and males diagnosed with iron deficiency anaemia are eligible.
• 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
• Administration of any iron-containing drugs during the last 3 months.
• History of erythropoietin drug administration.
• Hypersensitivity to iron therapy (both Oral and/or IV administration) and other components of the study drugs.
• 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.
• History of severe allergic reactions or drug intolerance.
• Fructose intolerance, glucose-galactose malabsorption syndrome, and sucrase-isomaltase deficiency.
• Failure of iron therapy for iron-deficiency anaemia in a patient's past medical history.
• Heme metabolism disorders (e.g., sideroachrestic anaemia, lead anaemia, thalassemia).
• Iron overload including hemochromatosis and hemosiderosis.
• 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.
• Dysfunction of the thyroid gland (based on the data obtained at screening).
• Laboratory and clinical signs of an active inflammatory process for 10 days before screening.
• AST, ALT, and total bilirubin levels exceeding the upper limit of normal 1.5 times and more.
• Clinically apparent hypothyroidism, in the investigator's opinion.
• 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.
• Signs of bone marrow aplasia at screening or history of bone marrow aplasia.
• 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
• 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.
• 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.
• Other significant diseases, at the discretion of the investigator.
• For non-pregnant Patients: lactating women, or women intending to become pregnant during the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomization numbers will be allocated to patients using a computer-generated randomization schedule. Each participant will be assigned a unique identifier corresponding to their treatment group. This process will be conducted by qualified personnel not involved in participant assessments to ensure unbiased and unpredictable treatment assignments. The randomization code will remain confidential until the completion of the study.

The study products, whether investigational or control, will be uniformly packaged to maintain identical appearance, texture, and any other relevant characteristics. Packaging will be devoid of any identifiable markings that could reveal the nature of the contained product.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization numbers will be allocated to patients using a computer-generated randomization schedule. Each participant will be assigned a unique identifier corresponding to their treatment group. This process will be conducted by qualified personnel not involved in participant assessments to ensure unbiased and unpredictable treatment assignments. The randomization code will remain confidential until the completion of the study.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Bio-equivalence
Statistical methods / analysis
The descriptive statistics for continuous variables will be presented with the number (n) of non-missing observations, mean, SD, median, and minimum and maximum (range). For categorical data, the descriptive statistics will be presented with the number of exposed patients and number (n) with a percentage of observations in the various categories of the endpoint, where the percentage will be based on the exposed patients. Descriptive analyses will also include graphical presentations of data wherever appropriate.
Given the non-inferiority nature of this trial, the primary analysis will focus on demonstrating the non-inferiority of Iron (III) Hydroxide Polymaltose 100mg Hard Gelatin Capsules compared to Maltofer® 370 mg Tablets (100mg iron as iron polymaltose). A one-sided statistical test will be employed to assess non-inferiority, utilizing a pre-specified margin of non-inferiority. This margin will be justified based on clinical relevance and prior literature.
Individual patient data listings will be provided, encompassing pregnant and non-pregnant women, as well as men diagnosed with iron deficiency. All analyses will be conducted using two-sided tests for secondary endpoints and where applicable. Subgroup analyses, particularly considering mild to moderate subgroups, will be performed for both primary and secondary endpoints.
A detailed SAP will be finalized, providing comprehensive methods for the analyses outlined above, before the database is locked and prior to the initiation of the trial's analysis. Any deviations from the analyses described above will be explicitly documented in the SAP. The statistical analysis will be performed using SAS software version 9.4 or higher (SAS Institute Inc., Cary, NC, USA).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
29/03/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
240
Accrual to date
Final
Recruitment outside Australia
Country [1] 26132 0
India
State/province [1] 26132 0
Maharashtra

Funding & Sponsors
Funding source category [1] 315733 0
Commercial sector/Industry
Name [1] 315733 0
AFT Pharmaceuticals Ltd
Country [1] 315733 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
AFT Pharmaceuticals Ltd
Address
Country
New Zealand
Secondary sponsor category [1] 317844 0
None
Name [1] 317844 0
Address [1] 317844 0
Country [1] 317844 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 314596 0
Humancare Independent Ethics Committee
Ethics committee address [1] 314596 0
Ethics committee country [1] 314596 0
India
Date submitted for ethics approval [1] 314596 0
14/03/2024
Approval date [1] 314596 0
Ethics approval number [1] 314596 0
Ethics committee name [2] 314597 0
Ethos Ethics Committee
Ethics committee address [2] 314597 0
Ethics committee country [2] 314597 0
India
Date submitted for ethics approval [2] 314597 0
15/02/2024
Approval date [2] 314597 0
Ethics approval number [2] 314597 0

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

Contacts
Principal investigator
Name 132130 0
Dr Spenta Katrak
Address 132130 0
Genecht Research Pvt. Ltd. Plot No. D-400, TTC Industrial Area, MIDC Nerul, Uran Phata Junction, Off Sion - Panvel Expy, Nerul, Navi Mumbai-400 706, Maharashtra, India.
Country 132130 0
India
Phone 132130 0
+919987154253
Fax 132130 0
Email 132130 0
[email protected]
Contact person for public queries
Name 132131 0
Dr Laura Boddington
Address 132131 0
AFT Pharmaceuticals Ltd. Level 1, 129 Hurstmere Road, Takapuna, Auckland, New Zealand 0622
Country 132131 0
New Zealand
Phone 132131 0
+64 9 4880232
Fax 132131 0
Email 132131 0
[email protected]
Contact person for scientific queries
Name 132132 0
Dr Laura Boddington
Address 132132 0
AFT Pharmaceuticals Ltd. Level 1, 129 Hurstmere Road, Takapuna, Auckland, New Zealand 0622
Country 132132 0
New Zealand
Phone 132132 0
+64 9 4880232
Fax 132132 0
Email 132132 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.