P-Monofer-CKD-02

• Research type

  Research Study

• Full title

  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 (NDD-CKD) and with renal-related anaemia.

• IRAS ID

  39586

• Contact name

  Philip Kalra

• Sponsor organisation

  Pharmacosmos A/S

• Eudract number

  2009-016728-29

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  The main objective of the study is to determine the effects of an investigational drug Iron Isomaltoside 1000 (Monofer©) in subjects not in dialysis who have Chronic Kidney Disease (NDD-CKD) (a renal disease characterized by progressive loss of renal function over a period of months or years) and with Iron Deficiency Anaemia (IDA) (Anaemia is a condition characterized by deficiency of blood). Clinical safety data is present for Iron Isomaltoside 1000 (Monofer©) but needs to be supplemented with effectiveness data in subjects with iron deficiency anemia requiring parenteral (administered by intravenous or intramuscular injection) iron therapy. NDD-CKD associated with IDA is one such condition where subjects require parenteral iron therapy. IDA is often associated with many chronic diseases such as renal diseases, cancer, infections (e.g. AIDS and malaria), chronic heart failure and inflammatory bowel disease. It is also common in elderly people who do not have any obvious symptoms of chronic disease. The mechanism behind anaemia in chronic disease is complex. Currently, parenteral iron is used in subjects with anaemia associated with chronic kidney disease treated with haemodialysis and erythropoiesis stimulating agents (ESA??s, i.e. epoetin or darbepoetin). Studies have shown that parenteral iron therapy may be superior to oral supplementation in such subjects. A total number of approximately 350 subjects will be randomized (like flipping a coin) in a ratio of 2:1 to either Iron Isomaltoside 1000 (Monofer©) or oral Iron Sulphate. The subjects randomized to Iron Isomaltoside 1000 (Monofer©) will be equally divided into groups A1 (administered as intravenous infusions) & A2 (administered as intravenous bolus injections). Subjects will at the trial hospital clinic be given intravenous infusions or repeated bolus injections of Iron Isomaltoside 1000 (Monofer©) - or subjects will twice daily swallow a tablet of oral iron sulphate at home for 8 weeks.

• REC name

  East Midlands - Leicester South Research Ethics Committee

• REC reference

  10/H0402/36

• Date of REC Opinion

  28 Jun 2010

• REC opinion

  Further Information Favourable Opinion