Efficacy, Safety and Tolerability Study of Subcutaneous C.E.R.A. in Pre-Dialysis Participants With Chronic Renal Anemia

Roche

Status and phase: Terminated; Phase 3

Conditions: Anemia

Treatments: Drug: Methoxy polyethylene glycol-epoetin beta (C.E.R.A.)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00517881

ML20944

2006-006523-40 (EudraCT Number)

Details and patient eligibility

About

This single arm study will assess the efficacy, safety and tolerability of subcutaneous methoxy polyethylene glycol-epoetin beta (C.E.R.A.) for maintenance of hemoglobin levels in pre-dialysis participants with chronic renal anemia. Participants currently receiving maintenance treatment with subcutaneous darbepoetin alfa will receive monthly subcutaneous injections of C.E.R.A. with the starting dose of 120, 200 or 360 micrograms (mcg) derived from the dose of darbepoetin alfa or epoetin alfa in the week preceding study start.

Enrollment: 29 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Chronic renal anemia
• Hemoglobin concentration between 10.5 gram per deciliter (g/dL) and 12.5 g/dL
• Adequate iron status (serum ferritin greater than [>] 100 nanogram per milliliter and Transferrin Saturation >20 percent [%] or hypochromic red cells less than [<] 10%)
• Continuous subcutaneous maintenance darbepoetin alfa therapy with same dosing interval during previous 2 months

Exclusion criteria

• Transfusion of red blood cells during previous 2 months
• Poorly controlled hypertension requiring hospitalization or interruption of darbepoetin alfa treatment in previous 6 months
• Acute or chronic bleeding
• Active malignant disease (except non-melanoma skin cancer)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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29 participants in 1 patient group

C.E.R.A.

Experimental group

Treatment:

Drug: Methoxy polyethylene glycol-epoetin beta (C.E.R.A.)