A Study of Subcutaneous C.E.R.A. for the Maintenance of Hemoglobin Levels in Participants With Chronic Renal Anemia Not on Dialysis.

Roche

Status and phase: Completed; Phase 3

Conditions: Anemia

Treatments: Drug: methoxy polyethylene glycol-epoetin beta [C.E.R.A.]

Study type: Interventional

Funder types: Industry

Identifiers

NCT00642304

ML20937

Details and patient eligibility

About

This single arm study will assess the efficacy and safety of subcutaneous C.E.R.A. when administered for the maintenance of hemoglobin levels in participants with chronic renal anemia, not on dialysis. Participants currently receiving maintenance treatment with subcutaneous darbepoetin alfa or epoetin beta will receive monthly injections of C.E.R.A., with the starting dose (120, 200 or 300 micrograms [mcg] subcutaneously [SC]) derived from the dose of darbepoetin alfa or epoetin beta they were receiving in the week preceding study start.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Chronic renal anemia
• Stable darbepoetin alfa or epoetin beta therapy for past 8 weeks

Exclusion criteria

• Transfusion of red blood cells during previous 8 weeks
• Poorly controlled hypertension requiring interruption of epoetin treatment in previous 6 months
• Acute or chronic bleeding requiring therapy within previous 8 weeks

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

methoxy polyethylene glycol-epoetin beta

Experimental group

Treatment:

Drug: methoxy polyethylene glycol-epoetin beta [C.E.R.A.]