Monofer® versus Intravenous Iron Sucrose in CKD-5D

• Research type

  Research Study

• Full title

  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).

• IRAS ID

  66964

• Contact name

  Sunil Bhandari

• Sponsor organisation

  Pharmacosmos A/S

• Eudract number

  2010-023471-26

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  This study aims to compare intravenous iron isomaltoside 1000 (Monofer©) with intravenous iron sucrOse in patients on maintenance iron therapy with Stage 5 Chronic Kidney Disease on dialysis therapy (CKD-5D). Whilst there is clinical safety data for Monofer© in patients with CKD-5D this needs to be supplemented with efficacy data from comparable study designs in subjects with Iron Deficiency Anaemia (IDA) requiring parenteral iron therapy (i.e. iron given intravenously). This study aims to collect such data in addition to confirming the safety of Monofer© by administering single or repeated bolus injections in comparison to intravenous iron'sucrise in CKD-5D patients 351 Participants will be randomised equally to one of three treatments:A1: Group Monofer© - 500 mg as a single intravenous bolus injection.A2: Group Monofer© - 500 mg in divided doses (100mg+200mg+200mg) as intravenous bolus injections.B: Group iron'sucrise - 500 mg in divided doses (100mg+200mg+200mg) as intravenous bolus injections.The treatment period is comprised of 7 visits (1a/1b, 2, 3, 4, 5, 6) over a 6 week period (the corresponding timeline to the visits is -16 days/7 days, week 0, weeks 1, 2, 4, 6) therefore individual participant duration could be up to 8 weeks depending on the screening period.Participants randomised to Group A1 will only receive Monofer© at Visit 2; those randomised to A2 will receive Monofer© at Visits 2, 4 and 5; those randomised to B will receive the comparator, iron'sucrise, at visits 2, 4 and 5. Safety and efficacy will be monitored via laboratory assessments at each visit in conjunction with adverse event / concomitant medication assessment. Finally quality of life assessment via questionnaire (at baseline, week 4 and end of study visit), and also an assessment of restless Leg Syndrome (RLS) symptoms via questionnaire (at baseline and end of study visit) will be done.

• REC name

  North East - Newcastle & North Tyneside 2 Research Ethics Committee

• REC reference

  11/NE/0124

• Date of REC Opinion

  8 Sep 2011

• REC opinion

  Further Information Favourable Opinion