A Study of Monthly Intravenous C.E.R.A. (Mircera) in Hemodialysis Participants With Chronic Renal Anemia (CARISMA)

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

NCT00699348

2007-005799-15 (EudraCT Number)

ML21438

Details and patient eligibility

About

This single arm study will assess the efficacy, safety and tolerability of once-monthly administration of intravenous methoxy polyethylene glycolepoetin beta (Mircera) for the maintenance of hemoglobin levels in hemodialysis participants with chronic renal anemia. Participants currently receiving intravenous epoetin alfa or beta or darbepoetin alfa will receive intravenous Mircera at a starting dose of 120, 200 or 360 micrograms/month (based on the erythropoietin stimulating agent [ESA] dose administered on week -1). Subsequent doses will be adjusted to maintain hemoglobin levels within the target range of 10 to12 gram per deciliter (g/dL). The anticipated time on study treatment is 1-2 years, and the target sample size is 100-500 individuals.

Enrollment: 351 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Chronic renal anemia;
• Continuous intravenous maintenance erythropoietin stimulating agent (ESA) treatment during previous month;
• Regular long term hemodialysis therapy with the same mode of dialysis for >=3 months.

Exclusion criteria

• Transfusion of red blood cells during previous 2 months;
• Significant acute or chronic bleeding, such as overt gastrointestinal 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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351 participants in 1 patient group

C.E.R.A.

Experimental group

Treatment:

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