Safety and Efficacy of Peginesatide Injection for the Maintenance of Anemia in Chronic Renal Failure Participants Who Are on Hemodialysis or Do Not Require Dialysis and Previously Treated With Darbepoetin Alfa.
Condition: Anemia
MeSH terms: Renal Insufficiency; Kidney Failure, Chronic; Anemia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the efficacy and safety of Peginesatide Injection
      for the maintenance of anemia in patients with chronic renal failure who are on hemodialysis
      or do not require dialysis and who were previously treated with Darbepoetin Alfa.
    

Detailed description: 
      Anemia, resulting primarily from insufficient production of erythropoietin to support
      erythropoiesis, is a common consequence of chronic renal failure. Both North America and
      Europe have established clinical practice guidelines for the treatment and hemoglobin targets
      in chronic renal failure/chronic kidney disease patients. These guidelines recommend the use
      of erythropoiesis-stimulating agents (ESAs). The benefits of ESA therapy include reduced
      fatigue, improved quality of life, decreased cardiovascular mortality risk and improved
      cardiovascular function. An increased risk of death and serious cardiovascular and
      thromboembolic events, including myocardial infarction, stroke, congestive heart failure, and
      hemodialysis graft occlusion have been observed in controlled clinical trials of ESAs when
      administered to target hemoglobin levels of ≥13.5 g/dL. The vast majority of patients
      receiving hemodialysis receive ESA therapy to treat their anemia and most patients begin ESA
      therapy prior to any requirement for dialysis.

      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 renal failure 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 30 weeks.
    

Intervention name(s): Peginesatide
Intervention type(s): Drug
Intervention description(s): Peginesatide 0.04 to 0.16 mg/kg, subcutaneous or intravenous injection, once every 4 weeks for up to 24 weeks. Initial dose based on patient's previous total weekly darbepoetin alfa 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
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Anemia; Drug Therapy; Hemodialysis; Kidney Failure