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

Trial Profile

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

Completed
Phase of Trial: Phase III

Latest Information Update: 19 Aug 2016

At a glance

  • Drugs Iron isomaltoside 1000 (Primary) ; Ferrous sulfate
  • Indications Iron deficiency anaemia
  • Focus Therapeutic Use
  • Acronyms PROGRESS
  • Sponsors Pharmacosmos
  • Most Recent Events

    • 19 Aug 2016 Primary endpoint (Change in hemoglobin (Hb) concentration from baseline to week 4 ) has been met, according to a Pharmacosmos media release.
    • 25 Jun 2014 Status changed from active, no longer recruiting to completed, as per ClinicalTrials.gov record.
    • 12 Jun 2014 New trial record
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