20060163 Randomized, Double-blind Study, Darbepoetin alfa, Anemia, CKD

• Research type

  Research Study

• Full title

  A Multicenter, Randomized, Double-blind Study Comparing De Novo Once Monthly and Once Every 2 Week Darbepoetin alfa Dosing for the Correction of Anemia in Subjects With Chronic Kidney Disease Not Receiving Dialysis

• IRAS ID

  17795

• Sponsor organisation

  Amgen Ltd

• Eudract number

  2006-003173-27

• ISRCTN Number

  N/A

• Research summary

  Subjects who will be asked to consider participating in this study, are patients with anaemia (low red blood cell count) associated with chronic kidney disease (CKD), who are not receiving dialysis. The study will test if taking darbepoetin alfa once monthly is as safe and effective as compared to taking darbepoetin alfa once every 2 weeks.Darbepoetin alfa is the investigational product, which will be given by injection under the skin. It belongs to a class of drugs known as erythropoiesis stimulating agents (ESAs), which stimulate red blood cell production. Darbepoetin alfa is already licensed in a number of countries, including the UK, for the treatment of anaemia in patients with CKD. Increasing the intervals between doses could be more convenient for patients and help give better anemia management.There will be a maximum 2-week screening period followed by a 32-week treatment period with an end of study visit in week 33. Therefore, each subject is involved in the study for a maximum of 35 weeks. During the treatment period, subjects will have to visit the hospital or clinic every two weeks for study assessments. Blood tests are taken to measure level of red blood cells, blood chemistry and pregnancy in women of child-bearing potential as pregnant women are not eligible for this study. Blood pressure will be taken at every visit, also physical examinations will be performed at screening and end of study. Subjects will be asked to complete a questionnaire on their health and well being 3 times during the study.Neither subject nor study doctor will know which treatment arm they are on. Out of 540 subjects worldwide, 270 will receive active medication every 2 weeks and the other 270 subjects will receive active medication every 4 weeks with inactive medication at the 2-week timepoint between active medication doses.

• REC name

  East Midlands - Leicester Central Research Ethics Committee

• REC reference

  09/H0406/45

• Date of REC Opinion

  27 May 2009

• REC opinion

  Further Information Favourable Opinion