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Sponsor: Hoffmann-La Roche
Conditions: Anemia
Interventions: methoxy polyethylene glycol-epoetin beta [Mircera]
Countries: Indonesia
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.
Sex: ALL
Age: 18 Years to —
Healthy volunteers: No
Study type: INTERVENTIONAL
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
- Bandung, Indonesia
- Denpasar, Indonesia
- Jakarta, Indonesia
- Jakarta, Indonesia
- Jakarta, Indonesia
- Jakarta, Indonesia
- Jakarta, Indonesia
- Medan, Indonesia
- Medan, Indonesia
- Semarang, Indonesia
- Surabaya, Indonesia
- Surabaya, Indonesia