At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 511 enrolled
Drug / intervention
iron isomaltoside 1000 (Monofer®) +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 3 clinical trial evaluating iron isomaltoside 1000 (Monofer®) and iron sucrose (Venofer®) for Iron Deficiency Anaemia. Completed, enrolled 511 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIron Deficiency Anaemia
CountriesUnited States
CollaboratorsBioStata, ClinStar, LLC, Laboratory Corporation of America
Timeline
Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartMay 2014
First PostedMay 2014
Primary CompletionAug 2015
TodayJul 2026
First PostedMay 2, 2014
Enrollment StartMay 1, 2014
Primary CompletionAug 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 12.2 years ago
Interventions
iron isomaltoside 1000 (Monofer®)drug
iron sucrose (Venofer®)drug