At a glance
ClinicalIndex Comparison Record- ✓Adult patients ≥18 years old with chronic renal anemia
- ✓Currently on maintenance erythropoietic therapy with methoxy polyethylene glycol-epoetin beta or reference medications (epoetin alfa with human albumin, epoetin beta, or darbepoetin alfa)
- ✓Hemoglobin concentration 10.5–13.0 g/dL
- ✓Adequate iron status: serum ferritin ≥100 ng/mL, or TSAT ≥20%, or <10% hypochromic RBCs
- ✕Poorly controlled hypertension
- ✕History of epileptic seizure
- ✕Pure red cell aplasia
- ✕Chronic congestive heart failure NYHA IV
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-label, Multi-center Study to Document the Efficacy, Safety, and Tolerability of Long-term Administration of RO0503821 in Patients With Chronic Renal Anemia
In Brief
A Phase 3 clinical trial evaluating Methoxy Polyethylene Glycol-Epoetin Beta, Epoetin alfa, and 2 other interventions for Anemia. Completed, enrolled 1,228 participants across 249 sites in 27 countries.
Detailed 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.
Study Details
Timeline
Interventions
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).