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IDA-01 A Randomised, Open-Label, Comparative Study of Intravenous Iron Isomaltoside 1000 (Monofer®) and Iron Sucrose (Provide)

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ClinicalTrials.gov Identifier: NCT02130063
Recruitment Status : Completed
First Posted : May 2, 2014
Results First Posted : May 22, 2018
Last Update Posted : September 27, 2018
Sponsor:
Collaborators:
BioStata
ClinStar, LLC
LabCorp
Information provided by (Responsible Party):
Pharmacosmos A/S

Brief Summary:
The purpose of the trial is to evaluate and compare the effect of iron isomaltoside 1000 to iron sucrose in its ability to increase haemoglobin (Hb) in subjects with IDA when oral iron preparations are ineffective or cannot be used or where there is a clinical need to deliver iron rapidly.

Condition or disease Intervention/treatment Phase
Iron Deficiency Anaemia Drug: iron isomaltoside 1000 (Monofer®) Drug: iron sucrose (Venofer®) Phase 3

Detailed Description:

IDA is highly prevalent in subjects with gastrointestinal diseases and cancer, menstruating or pregnant women, and subjects who have undergone bariatric procedure. IDA can have a substantial medical and quality of life (QoL) burden on the subjects and the treatment of these subjects includes controlling the bleeding and replenishing lost iron. Oral iron administration is often used in the clinical practice at many clinics; however, oral iron may not be tolerated by all subjects. Hence, there is a need for an alternative iron treatment in subjects, who do not tolerate oral iron.

This study is planned to compare the efficacy and safety of iron isomaltoside 1000 with another parenteral iron preparation (iron sucrose) in subjects with IDA and who are intolerant or unresponsive to oral iron therapy or who need iron rapidly.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 511 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase III, Randomised, Open-Label, Comparative Study of Intravenous Iron Isomaltoside 1000 (Monofer®) and Iron Sucrose in Subjects With Iron Deficiency Anaemia and Who Are Intolerant or Unresponsive to Oral Iron Therapy or Who Need Iron Rapidly (PROVIDE)
Study Start Date : May 2014
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia Iron

Arm Intervention/treatment
Experimental: iron isomaltoside 1000 (Monofer®)
iron isomaltoside 1000 (Monofer®)
Drug: iron isomaltoside 1000 (Monofer®)
Active Comparator: iron sucrose (Venofer®)
iron sucrose (Venofer®)
Drug: iron sucrose (Venofer®)



Primary Outcome Measures :
  1. Number of Subjects With an Haemoglobin (Hb) Increase of ≥ 2 g/dL From Baseline at Any Time From Week 1 to Week 5 [ Time Frame: From baseline to week 5 ]

    The primary efficacy endpoint of the trial was the count of subjects with an Hb increase of ≥ 2 g/dL from baseline at any time from week 1 to week 5. 'Any time' implied that if the endpoint was met at a time-point prior to or at week 5, the effect (increase of ≥ 2 g/dL) did not have to be maintained throughout the trial in order for a subject to be a responder.

    Number of responders (i.e. a subject with increase in Hb ≥ 2 g/dL from baseline at any time from week 1 to week 5) and percentages according to number of subjects in the analysis set were summarised.



Secondary Outcome Measures :
  1. Change in Hb Concentration [ Time Frame: From baseline to week 2, 4 and 5 ]
  2. Change in Serum (s)-Ferritin Concentration [ Time Frame: From baseline to week 1, 2, 4, and 5 ]
  3. Change in Transferrin Saturation (TSAT) [ Time Frame: From baseline to week 1, 2, 4, and 5 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Men or women > 18 years having IDA caused by different aetiologies such as abnormal uterine bleeding, gastrointestinal diseases, cancer, bariatric procedures (gastric bypass operations), and other conditions leading to significant blood loss and with a documented history of intolerance or unresponsiveness to oral iron therapy for at least one month prior to study enrollment or where there at investigators judgment is a clinical need to deliver iron rapidly
  2. Hb < 11 g/dL
  3. TSAT < 20 %
  4. S-ferritin < 100 ng/mL
  5. Willingness to participate and signing the informed consent form

Exclusion Criteria:

  1. Anaemia predominantly caused by factors other than IDA (e.g. anaemia with untreated vitamin B12 or folate deficiency, haemolytic anaemia)
  2. Iron overload or disturbances in utilisation of iron (e.g. haemochromatosis and haemosiderosis)
  3. Decompensated liver cirrhosis or active hepatitis (ALAT > 3 times upper limit of normal)
  4. Active acute or chronic infections (assessed by clinical judgement supplied with white blood cells (WBC) and C-reactive protein (CRP))
  5. Body weight < 50 kg
  6. Rheumatoid arthritis with symptoms or signs of active inflammation
  7. Pregnant or nursing women. In order to avoid pregnancy, women have to be surgically sterile or use adequate contraception (e.g. intrauterine devices, hormonal contraceptives, or double barrier method) during the whole study period and after the study has ended for at least 5 times plasma biological half-life of the investigational medicinal product
  8. History of multiple allergies
  9. Known hypersensitivity to parenteral iron or any excipients in the investigational drug products
  10. Erythropoietin treatment within 8 weeks prior to the screening visit
  11. Other iron treatment or blood transfusion within 4 weeks prior to the screening visit
  12. Planned elective surgery during the study
  13. Participation in any other clinical study within 3 months prior to the screening
  14. Any other medical condition that, in the opinion of Investigator, may cause the subject to be unsuitable for the completion of the study or place the subject at potential risk from being in the study, e.g. uncontrolled hypertension, unstable ischaemic heart disease, or uncontrolled diabetes mellitus

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02130063


Locations
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United States, Delaware
Wilmington, Delaware, United States
Sponsors and Collaborators
Pharmacosmos A/S
BioStata
ClinStar, LLC
LabCorp

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Responsible Party: Pharmacosmos A/S
ClinicalTrials.gov Identifier: NCT02130063     History of Changes
Other Study ID Numbers: P-Monofer-IDA-01
First Posted: May 2, 2014    Key Record Dates
Results First Posted: May 22, 2018
Last Update Posted: September 27, 2018
Last Verified: August 2015

Keywords provided by Pharmacosmos A/S:
IDA
Iron deficiency
iron deficiency anaemia and who are intolerant or unresponsive to oral iron therapy

Additional relevant MeSH terms:
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Anemia
Anemia, Iron-Deficiency
Deficiency Diseases
Hematologic Diseases
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases
Malnutrition
Nutrition Disorders
Iron
Ferric Oxide, Saccharated
Ferric Compounds
Iron isomaltoside 1000
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Hematinics