A Study of Intravenous Mircera in Hemodialysis Patients With Chronic Renal Anemia

Roche

Status and phase: Completed; Phase 3

Conditions: Anemia

Treatments: Drug: methoxy polyethylene glycol-epoetin beta

Study type: Interventional

Funder types: Industry

Identifiers

NCT00661505

ML21096

Details and patient eligibility

About

This single arm study will assess the efficacy, safety and tolerability of once-monthly administration of intravenous Mircera for the maintenance of hemoglobin levels in hemodialysis patients with chronic renal anemia. Patients will receive 4-weekly intravenous injections of Mircera, at a starting dose of 120, 200 or 360 micrograms. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Enrollment: 132 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• adult patients, >= 18 years of age;
• chronic renal anemia;
• continuous stable iv or sc maintenance epoetin therapy during previous 4 weeks;
• regular long-term hemodialysis therapy with the same mode of dialysis for previous 3 months.

Exclusion criteria

• transfusion of red blood cells during previous 2 months;
• poorly controlled hypertension requiring hospitalization or interruption of epoetin treatment in previous 6 months;
• significant acute or chronic bleeding.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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132 participants in 1 patient group

C.E.R.A. 120, 200, or 360 mcg

Experimental group

Description:

Eligible participants were administered Continuous Erythropoietin Receptor Activator (C.E.R.A.) at a dose of 120, 200, or 360 microgram (mcg), intravenously (IV), every 4 weeks i.e. Weeks 4, 8, 12, 16 and 20 but not on Weeks 24 and 28. The initial dose of C.E.R.A.was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA). The ESA therapy was administered from enrollment to the 4 weeks stability verification period (SVP), weekly, either as epoetin (\<8000 IU, 8000-16000 IU, or \>16000 IU) or darbepoetin alpha (\<40 mcg, 40-80 mcg, or \>80 mcg). A telephone follow-up visit took place 4 weeks after the end of C.E.R.A. treatment (Week 28).

Treatment:

Drug: methoxy polyethylene glycol-epoetin beta