Clinical trial NCT00090753
Conditions: Anemia
Sponsor: Hoffmann-La Roche
Start date: 2004-10-01; Completion date: 2009-12-01
Enrollment: 1228 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief 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.

Detailed description:

Arms: arm 1: Patients received the same weekly dose of methoxy polyethylene glycol-epoetin beta via the same route of administration (iv or sc) as they received in the Phase II or Phase III study that qualified the patient for participation in this study. Methoxy polyethylene glycol-epoetin beta was administered every 2 or every 4 weeks in the initial 104-week treatment period. Patients on a 4-week dosing interval were switched to once-monthly administration in the 24-month extension phase. The dose of methoxy polyethylene glycol-epoetin beta was adjusted to maintain the patient's hemoglobin (Hb) within a target range of 11 to 13 g/dL. arm 2: Patients received the same comparator ESA \[epoetin alfa, epoetin beta, or darbepoetin alfa\] at the same weekly dose and dosing interval via the same route of administration (iv or sc) as they received in the Phase III study that qualified the patient for participation in this study. The dose of the comparator drug was adjusted to maintain the patient's Hb within a target range of 11 to 13 g/dL. Of the 480 patients in the comparator drug group, 170 received darbepoetin alfa, 134 received epoetin alfa, and 176 received epoetin beta.
Interventions: intervention 1: Methoxy Polyethylene Glycol-Epoetin Beta intervention 2: Epoetin alfa intervention 3: Epoetin beta intervention 4: Darbepoetin alfa
Intervention descriptions: intervention 1: 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. intervention 2: Epoetin alfa was provided with commercial packaging in English with country-specific labels (10,000 IU, 20,000 IU). intervention 3: Epoetin beta was provided with commercial packaging in English with country-specific labels (50,000 IU, 100,000 IU). intervention 4: Darbepoetin alfa was provided with commercial packaging in English with country-specific labels (vials and PFSs in various strengths).

Protocol documents: