Conversion Study From Epoetin Alfa to Monthly Peginesatide Injection in Patients With Chronic Kidney Disease on Dialysis
Condition: Chronic Kidney Disease; Anemia
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Intervention: Epoetin; Peginesatide
Intervention description: Commercially available epoetin alfa administered weekly, twice weekly, or thrice weekly at an initial starting dose, frequency of administration, and mode of administration (intravenous [IV] or subcutaneous [SC]) individually determined for each participant using the site's usual standard of care. Subsequent dose adjustments or dose holds may have been made in order to maintain a hemoglobin concentration of <11 g/dL.; Administered as a once monthly intravenous (IV) or subcutaneous (SC) injection. The initial dose of peginesatide injection was based on the final weekly dose of epoetin administered in the SCP; subsequent doses may have been adjusted in order to maintain hemoglobin concentrations at <11 g/dL.
Intervention MeSH terms: Epoetin Alfa
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 184.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Anemia; Chronic Renal Failure; CRF; Chronic Kidney Disease; CKD; Erythropoietin; Hematide; Peginesatide; Hemoglobin; Hgb; Red Blood Cell; Red Blood Cell Production; Dialysis

Summary:

      The purpose of this study is to understand the effects of a dialysis center switching its
      dialysis patients from using Epoetin alfa to peginesatide injection on hemoglobin levels and
      other parameters.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have provided written informed consent in accordance with institutional, local, and
             national guidelines

          -  Are ≥18 years of age at the start of screening

          -  Have been on in-center hemodialysis for ≥12 weeks at the start of screening

          -  Are currently maintained on Epoetin at the start of screening

          -  If sexually active and a female of childbearing potential, are willing to use highly
             effective method of birth control ≥4 weeks before study enrollment and through the
             study

          -  If a female of childbearing potential, have a negative pregnancy test during screening

        Exclusion Criteria:

          -  Are scheduled for a renal transplantation during study (Note: patients awaiting
             transplantation with no date scheduled may enroll.)

          -  Have an active malignancy or malignancy treated within one year prior to the start of
             screening for curative or palliative intent (Note: patients with non-melanoma skin
             cancers may enroll.)

          -  Have known intolerance to any ESA or PEGylated molecule

          -  Have been exposed to any investigational agent during the four weeks prior to the
             start of screening or are anticipated to receive such agents during the study

          -  Have any significant medical or psychiatric condition judged by the investigator to
             prevent informed consent or study compliance

          -  Are pregnant or nursing