A Study for Monthly Methoxy Polyethylene Glycol-Epoetin Beta Treatment in Patients With Chronic Renal Anaemia

• Status: Terminated
• Trial end date: 2011-09-30
• Target enrollment: 0
• Participant gender: All

Summary

This open-label single-arm study will evaluate the efficacy, safety and tolerability of methoxy polyethylene glycol epoetin beta on long-term maintenance of haemoglobin levels in patients with chronic renal anaemia. Patients will receive methoxy polyethylene glycol-epoetin beta intravenously once monthly at initial doses of either 120 micrograms or 200 micrograms or 360 micrograms in the titration phase of 16 weeks with a potential dose adjustment in the evaluation phase of 8 weeks. The anticipated time on study treatment is 24 weeks. The target sample size is 50-100 patients.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Epoetin Alfa

Criteria

Inclusion Criteria:

• Adults >/=18 years of age

• Chronic renal anaemia

• Haemoglobin concentration between 10 and 12 g/dL at screening

• Adequate iron status

• Continuous intravenous maintenance short-acting therapy with same dosing interval for 8 weeks prior to screening

• Regular long-term haemodialysis therapy for at least 12 weeks prior to screening

Exclusion Criteria:

• Change in haemoglobin concentration >/=2 g/dL during screening

• Transfusion of red blood cells less than 8 weeks prior to screening

• Poorly controlled hypertension

• Relevant acute or chronic bleeding requiring treatment less than 8 weeks prior to screening

• Active malignant disease

• Haemolysis

• Haemoglobinopathies