Efficacy and Safety of Peginesatide Injection for the Maintenance Treatment of Anemia in Peritoneal Dialysis Participants Previously Treated With Epoetin.
Condition: Anemia
MeSH terms: Anemia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the efficacy and safety of peginesatide injection
      for maintenance treatment of anemia in participants on peritoneal dialysis.
    

Detailed description: 
      According to the International Federation of Renal Registries, in 1999 the prevalence of
      peritoneal dialysis in the United States as approximately 9.5% of patients receiving dialysis
      (2005 United States Renal Data Systems data indicates a prevalence of around 7.5%). Data from
      Europe in 1999 to 2000 (not including the United Kingdom, France or Germany) indicated
      peritoneal dialysis was the mode of dialysis in approximately 11.1% of dialysis patients.
      2006 data from the United Kingdom indicates that more than 20% of patients on dialysis are
      receiving peritoneal dialysis while French and German data indicate rates of 8.1% and 4.8%
      respectively. More than 90% of patients with chronic renal failure/chronic kidney disease
      Stage 5 (End Stage Renal Disease) are anemic. The vast majority of patients receiving
      hemodialysis or peritoneal dialysis receive erythropoiesis-stimulating agent therapy to treat
      their anemia.

      Anemia of chronic renal failure is due to several factors, primarily the inability of the
      diseased kidneys to produce adequate amounts of endogenous erythropoietin. Ancillary factors
      also include the shortened lifespan of red blood cells, iron and other nutritional
      deficiencies, infection, and inflammation. The prevalence of anemia increases with
      progressive deterioration of renal function, and affects more than 90% of patients with
      chronic kidney disease (CKD) Stage 5 (End Stage Renal Disease). Anemia is associated with
      increased mortality, increased likelihood of hospitalization, reduced cognitive function and
      exercise capacity, increased left ventricular hypertrophy and heart failure. Treatment of
      anemia reduces morbidity and mortality risks and may improve quality of life.

      Erythropoiesis stimulating agents have been established as a treatment for anemia in chronic
      renal failure participants, and have improved the management of anemia over alternatives such
      as transfusion. Peginesatide (hematide) is a parenteral formulation being developed for the
      correction of anemia in patients with chronic renal failure, and binds to and activates the
      human erythropoietin receptor and stimulates erythropoiesis in human red cell precursors in a
      manner similar to other known erythropoiesis-stimulating agents.

      Participants in this study received variable doses of peginesatide injection once every four
      weeks. Total commitment time for this study was about 29 weeks.
    

Intervention name(s): Peginesatide
Intervention type(s): Drug
Intervention description(s): Peginesatide 0.04 to 0.16 mg/kg, subcutaneous injection, once every 4 weeks for up to 25 weeks. Initial dose based on patient's previous total weekly Epoetin dose, and thereafter could be adjusted to maintain hemoglobin values in the target range of 10 to 12 g/dL and ±1.5 g/dL from Baseline.
Other intervention name(s): Hematide; AF37702; Omontys
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Anemia; Drug Therapy; Peritoneal Dialysis.