Mircera has been studied in six main studies involving a total of 2,399 adults with anaemia associated with chronic kidney disease. Mircera was compared with other medicines used to stimulate red blood cell production. Two of these studies involved patients who were starting treatment for anaemia. The first study, in 181 patients on dialysis (a blood clearance technique used in advanced kidney disease), looked at Mircera injected into a vein every two weeks over 24 weeks and compared it with epoetin alfa or beta. The second study, in 324 patients not on dialysis, looked at Mircera injected under the skin every two weeks over 28 weeks, comparing it with darbepoetin alfa.
The other four studies (in 1,894 patients) were carried out in patients on dialysis who had already been receiving medicines to stimulate red blood cell production. In these studies, patients either remained on the medicines they were already receiving, or changed to Mircera, injected into a vein or under the skin every two or four weeks. The effectiveness of the two treatment options was compared over 36 weeks.
In all six studies, the main measure of effectiveness was the change in haemoglobin levels. Most patients also received iron to prevent deficiency (low iron levels) during the studies.