20050256 Darbepoetin alfa in paediatric subjects with anaemia and CKD

• Research type

  Research Study

• Full title

  A Multicentre, Double-blind, Randomised Study Evaluating De Novo Weekly and Once Every 2 Week Darbepoetin alfa Dosing for the Correction of Anaemia in Paediatric Subjects With Chronic Kidney Disease Receiving and Not Receiving Dialysis (20050256)

• IRAS ID

  26192

• Contact name

  Margaret Fitzpatrick

• Eudract number

  2008-003418-88

• ISRCTN Number

  N/A

• Research summary

  The correction of anaemia substantially improves quality of life and observational studies suggest that the treatment of anaemia is associated with reduced hospitalisations and better outcomes in patients with Chronic Kidney Disease (CKD). Data suggest that anaemia is also under treated in children with CKD who have not yet started to receive dialysis. This under-treatment may be due to the frequency of injections required. Therefore the purpose of this research study is to assess the safety and effectiveness of darbepoetin alfa in the correction of anaemia in children with CKD, using both a weekly and two weekly dosing interval. It is hoped that increasing the dosing interval to two weeks will decrease the burden on the health care system and represent a benefit to both patients and their caregivers.Darbepoetin alfa is already licensed in the European Union for the treatment of anaemia in patients with CKD and it belongs to a class of drugs that stimulate red blood cell production. All patients participating in the study will receive the study drug which will be administered as an injection under the skin or into a vein through dialysis access.Patients between the ages of 1 to 18 who meet the inclusion criteria and are willing to participate will be asked to provide written informed consent. Eligible patients will then proceed into the 24 week treatment phase where they will be asked to visit their study doctor once a week. An end of study visit will take place at week 25. Safety data will be collected throughout the study. Patients will also be asked to undergo a physical examination to assess general wellbeing, complete quality of life questionnaires, provide blood samples for testing, and allow various vital signs to be measured. If appropriate, a pregnancy test will also be performed.

• REC name

  North East - York Research Ethics Committee

• REC reference

  10/H0903/67

• Date of REC Opinion

  3 Mar 2011

• REC opinion

  Further Information Favourable Opinion