BH21260- Mircera® vs. reference ESAs in CKD patients

• Research type

  Research Study

• Full title

  BH21260- A randomised, controlled, open-label, multi-centre, parallel-group study to assess all-cause mortality and cardiovascular morbidity in patients with chronic kidney disease on dialysis and those not on renal replacement therapy under treatment with MIRCERA® or reference Erythropoetin Stimulations Agents.

• IRAS ID

  6049

• Contact name

• Sponsor organisation

  F. Hoffman-La Roche Ltd., Basel

• Eudract number

  2007-005129-31

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  Chronic kidney disease (CKD)leads to permanent loss of kidney function and results in damage to the kidneytissue. Approximately one in ten people have CKD. In patients aged over 75years, CKD is present in one out of two people. Renal failure contributes tothe death of more than 7,000 people in the UK every year. Anaemia is a commoncomplication of CKD and there are approximately 100,000 people in the UK with CKD whoalso have anaemia. Mircera© is a long-acting erythropoietin stimulatingagent(ESA)that can increase the number of red blood cells and thereforehaemoglobin levels in the blood. Mircera© can stay in the circulation more than10 times longer than the ESA??s currently on the market. This helps the drug towork longer and reduces the number of injections a patient would require. Theaim of this open label study is to gain more experience with MIRCERA© and todemonstrate non-inferiority in a long term randomized study to assess safety inpatients treated with Mircera compared to patients treated with another ESAunder normal clinical practice conditions in a broad and largely unselectedpatient population. Approximately 2800 patients will be selected from aroundthe world, 100 of whom will come from the UK. The research will be conductedat centres in London, Birmingham,Oxford, Exeter, Hull, Swansea, Belfast, Hull, Bradford andLeicester. This research is being sponsored byRoche Products Ltd.

• REC name

  South Central - Hampshire A Research Ethics Committee

• REC reference

  08/H0502/132

• Date of REC Opinion

  14 Nov 2008

• REC opinion

  Further Information Favourable Opinion