CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 351 enrolled
Drug / intervention
Monofer +1 moredrug
Likely dose
Monofer 500 mgfrom 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.

Search/NCT01222884
NCT01222884Phase 3Completed
CompareCT.gov

A Phase III, Randomized, Comparative, Open-label Study of Intravenous Iron Isomaltoside 1000 (Monofer®) Administered as Maintenance Therapy by Single or Repeated Bolus Injections in Comparison With Intravenous Iron Sucrose in Subjects With Stage 5 Chronic Kidney Disease on Dialysis Therapy (CKD-5D)

Pharmacosmos A/S·interventional·Posted Oct 18, 2010·Updated Dec 2, 2015

In Brief

A Phase 3 clinical trial evaluating Monofer and Iron sucrose for Chronic Kidney Disease Stage 5 (Dialysis Dependent). Completed, enrolled 351 participants across 1 site.

Detailed Summary

The purpose of this study is to compare the efficacy and safety of intravenous iron isomaltoside 1000 with intravenous iron sucrose in patients suffering from Stage 5 Chronic Kidney Disease on Dialysis Therapy (CKD-5D).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Kidney Disease Stage 5 (Dialysis Dependent)
CountriesIndia
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedOct 18, 2010
Enrollment StartJun 1, 2011
Primary CompletionOct 1, 2013
Study CompletionDec 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 15.7 years ago

Interventions

Monoferdrug

Iron isomaltoside 1000 (Monofer®) administered as 500 mg intravenous single bolus injection over approximately 2 minutes

Iron sucrosedrug

Iron sucrose is administered undiluted in doses of 100mg at baseline, 200mg at week 2 and 200 mg at week 4 as fractionated IV bolus injections according to local Summary of Product Characteristics