At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 351 enrolled
Drug / intervention
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, Randomized, Comparative, Open-label Study of Intravenous Iron Isomaltoside 1000 (Monofer®) Administered by Infusions or Repeated Bolus Injections in Comparison With Oral Iron Sulphate in Subjects With Non-Dialysis Dependent Chronic Kidney Disease and With Renal-Related Anaemia
In Brief
A Phase 3 clinical trial evaluating Monofer and Iron Sulphate for Iron Deficiency Anemia and Chronic Kidney Disease. Completed, enrolled 351 participants across 1 site.
Detailed Summary
The study is designed to determine the effects of an investigational drug Monofer in subjects with non-dialysis dependent chronic kidney disease (NDD-CKD) subjects and with iron deficiency anaemia (IDA).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIron Deficiency Anemia, Chronic Kidney Disease
CountriesDenmark
Collaborators--
Timeline
Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartApr 2010
First PostedApr 2010
Primary CompletionJun 2014
TodayJul 2026
First PostedApr 13, 2010
Enrollment StartApr 1, 2010
Primary CompletionJun 1, 2014
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 16.2 years ago
Interventions
Monoferdrug
Infusion or injections
Iron Sulphatedrug
Oral intake