Switch of Darbeopetin to AF37702 Injection in Haemodialysis Patients

• Research type

  Research Study

• Full title

  A Phase 2 Study of the Safety and Efficacy of AF37702 Injection for the Maintenance Treatment of Anaemia in Subjects with Chronic Renal Failure Who Are on Haemodialysis or Do Not Require Dialysis and Previously Treated with Darbepoetin Alfa

• IRAS ID

  5661

• Sponsor organisation

  Takeda Global Research & Development Centre (Europe) Ltd.

• Eudract number

  2008-003459-64

• Research summary

  Anaemia occurs when there isnot enough haemoglobin in the blood. Haemoglobin gives red blood cells theircolour and is responsible for carrying oxygen around the body. Erythropoietinis produced by the kidneys and helps in formation of new red blood cells,therefore maintaining haemoglobin levels in the blood. In patients with kidneyfailure, erythropoietin levels may be low and therefore haemoglobin levels mayalso be lowered, which can cause anaemia. Anaemia is associated with reducedexercise capacity, increased chance of hospitalisation, reduced mental activityand understanding, deterioration in heart function and increased mortality.Anaemia in chronic kidney failure may be due to several factors. As describedabove, the main factor is the inability to produce enough erythropoietin, butother factors include, a shortened lifespan of red blood cells, lack of iron andother nutrients, infection, and inflammation. The chance of anaemia is greaterwith worsening kidney function, and more than 90% of patients with advancedkidney disease are affected. Treatment of anaemia may reduce these associatedproblems and improve quality of life. Therefore, anaemia should be diagnosedand treated as soon as possible. Medicines which improve the process by whichnew red blood cells are made are effective treatments for anaemia in chronickidney failure. They are the preferred treatment over blood transfusion, andare called ESAs (erythropoiesis stimulating agents, with erythropoiesis meaningproduction of new red blood cells). A frequently used ESA is Darbepoetin Alfa,which is given as an injection once a week. Early studies with a new ESA,Hematide Injection, showed that it is well tolerated and can increase andmaintain haemoglobin levels for a longer period than other ESAs. This suggeststhat treatment of anaemia with Hematide Injection may involve less frequentinjections compared to the current therapies.

• REC name

  East of Scotland Research Ethics Service REC 2

• REC reference

  08/S0501/70

• Date of REC Opinion

  28 Oct 2008

• REC opinion

  Further Information Favourable Opinion