A Study of Intravenous or Subcutaneous Methoxy Polyethylene Glycol-Epoetin Beta (RO0503821, Mircera) in Chronic Kidney Disease Patients With Renal Anemia
Condition: Anemia
MeSH terms: Anemia
Intervention: Methoxy Polyethylene Glycol-Epoetin Beta; Epoetin alfa; Epoetin beta; Darbepoetin alfa
Intervention description: Methoxy polyethylene glycol-epoetin beta was provided as a sterile single-use injectable solution in 2-mL glass vials containing 1 mL solution or in single-use sterile pre-filled syringes (PFSs) containing 0.3 mL or 0.6 mL injectable solution. The injectable solution was available in vials with the following strengths: 50, 100, 200, 400, and 1000 μg/mL. The injectable solution was available in PFSs with the following strengths: 30, 40, 50, 60, 75, 100, 120, 150, 200, and 250 μg/0.3 mL; and 360 and 400 μg/0.6 mL.; Epoetin alfa was provided with commercial packaging in English with country-specific labels (10,000 IU, 20,000 IU).; Epoetin beta was provided with commercial packaging in English with country-specific labels (50,000 IU, 100,000 IU).; Darbepoetin alfa was provided with commercial packaging in English with country-specific labels (vials and PFSs in various strengths).
Intervention MeSH terms: Epoetin Alfa; Darbepoetin alfa
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1228.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study assessed the long-term efficacy, safety, and tolerability of intravenous (iv) or
      subcutaneous (sc) methoxy polyethylene glycol-epoetin beta in chronic kidney disease patients
      with renal anemia. Eligible patients were those who were receiving stable maintenance therapy
      with methoxy polyethylene glycol-epoetin beta or erythropoiesis stimulating agents (ESAs) in
      Phase II or III clinical studies. They continued to receive methoxy polyethylene
      glycol-epoetin beta or comparator ESAs at the same weekly dose and by the same route of
      administration (sc or iv) as in the qualifying studies.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Written informed consent

          -  Adult patients (≥ 18 years old) with chronic renal anemia

          -  Maintenance erythropoietic therapy with methoxy polyethylene glycol-epoetin beta or a
             protocol-specified reference medication (epoetin alfa formulated with human albumin,
             epoetin beta or darbepoetin alfa) in one of the following studies:
             BA16528[NCT00048048], BA16285[NCT00048035], BA16286[NCT00364832],
             BA16736[NCT00077597], BA16738[NCT00081471], BA16739[NCT00077610],
             BA16740[NCT00077623], BA17283[NCT00077766] and BA17284[NCT00081484]

          -  Hemoglobin (Hb) concentration between 10.5 and 13.0 g/dL

          -  Adequate iron status defined as serum ferritin ≥ 100 ng/mL or Transferrin Saturation
             (TSAT)≥ 20% or percentage of hypochromic red blood cells (RBCs) < 10%

        Exclusion Criteria:

          -  Poorly controlled hypertension

          -  History of epileptic seizure

          -  Pure red cell aplasia

          -  Chronic congestive heart failure [New York Heart Association (NYHA) IV]

          -  High likelihood of early withdrawal or interruption of the study

          -  Active malignant disease (except non-melanoma skin cancer)

          -  Life expectancy less than 12 months

          -  Pregnancy or breast-feeding