AF37702 Injection for Anaemia in Peritoneal Dialysis Patients

• Research type

  Research Study

• Full title

  AFX01_201 A Phase II Study of the Safety and Efficacy of AF37702 Injection for the Maintenance Treatment of Anaemia in Peritoneal Dialysis Subjects Previously Treated with Epoetin

• IRAS ID

  4495

• Contact name

  Iain MacDougall

• Sponsor organisation

  Takeda Global Research & Development Centre (Europe) Ltd.

• Eudract number

  2008-003458-13

• Research summary

  Anaemia occurs when there is not enough haemoglobin in the blood. Haemoglobin gives red blood cells their colour and is responsible for carrying oxygen around the body. Erythropoietin is produced by the kidneys and helps in formation of new red blood cells, therefore maintaining haemoglobin levels in the blood. In patients with kidney failure, erythropoietin levels may be low and therefore haemoglobin levels may also be lowered, which can cause anaemia. Anaemia is associated with reduced exercise capacity, increased chance of hospitalisation, reduced mental activity and understanding, deterioration in heart function and increased mortality. Anaemia in chronic kidney failure may be due to several factors. As described above, the main factor is the inability to produce enough erythropoietin, but other factors include, a shortened lifespan of red blood cells, lack of iron and other nutrients, infection, and inflammation. The chance of anaemia is greater with worsening kidney function, and more than 90% of patients with advanced kidney disease are affected. Treatment of anaemia may reduce these associated problems and improve quality of life. Therefore, anaemia should be diagnosed and treated as soon as possible. Medicines which improve the process by which new red blood cells are made are effective treatments for anaemia in chronic kidney failure. They are the preferred treatment over blood transfusion, and are called ESAs (erythropoiesis stimulating agents, with erythropoiesis meaning production of new red blood cells). A frequently used ESA is Epoetin, which is given as an injection 2-3 times a week. Early studies with a new ESA, Hematide Injection, showed that it is well tolerated and can increase and maintain haemoglobin levels for a longer period than other ESAs. This suggests that treatment of anaemia with Hematide Injection may involve less frequent injections compared to the current therapies.

• REC name

  East of Scotland Research Ethics Service REC 2

• REC reference

  08/S0501/71

• Date of REC Opinion

  29 Oct 2008

• REC opinion

  Further Information Favourable Opinion