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

Roche

Status and phase: Terminated; Phase 4

Conditions: Anemia

Treatments: Drug: methoxy polyethylene glycol-epoetin beta [Mircera]

Study type: Interventional

Funder types: Industry

Identifiers

NCT01066000

ML21736

Details and patient eligibility

About

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.

Enrollment: 33 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

33 participants in 1 patient group

Mircera

Experimental group

Treatment:

Drug: methoxy polyethylene glycol-epoetin beta [Mircera]