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
|Condition or disease||Intervention/treatment||Phase|
|Iron Deficiency Anaemia||Drug: iron isomaltoside 1000 (Monofer®) Drug: iron sucrose (Venofer®)||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||511 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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®)
- 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.
- Change in Hb Concentration [ Time Frame: From baseline to week 2, 4 and 5 ]
- Change in Serum (s)-Ferritin Concentration [ Time Frame: From baseline to week 1, 2, 4, and 5 ]
- Change in Transferrin Saturation (TSAT) [ Time Frame: From baseline to week 1, 2, 4, and 5 ]
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
|United States, Delaware|
|Wilmington, Delaware, United States|