MIRACLE Study: A Study of Once-Monthly Intravenous Mircera in Hemodialysis Participants 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

NCT00545571

ML20826

Details and patient eligibility

About

This single-arm study will assess the long-term maintenance of hemoglobin levels, safety, and tolerability of once-monthly intravenous administration of Mircera in hemodialysis participants with chronic renal anemia. Those currently receiving darbepoetin alfa, epoetin alfa, or epoetin beta maintenance treatment will receive intravenous Mircera at a starting dose of 120, 200, or 360 micrograms (mcg) per month (based on the erythropoiesis stimulating agent [ESA] dose administered on Week -1). Subsequent doses will be adjusted to maintain hemoglobin levels within the country-specific target range (11 to 13 grams per deciliter [g/dL] for Switzerland and 10 to 12 g/dL for Austria).

Enrollment: 120 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults greater than or equal to (≥) 18 years of age
• Chronic renal anemia
• Hemoglobin concentration in country-specific target range (Switzerland: 11 to 13 g/dL; Austria: 10 to 12 g/dL)
• Regular long-term hemodialysis therapy with the same mode of dialysis for ≥3 months
• Continuous intravenous or subcutaneous maintenance ESA treatment during previous 2 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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120 participants in 1 patient group

Mircera in Renal Anemia

Experimental group

Description:

Participants will receive intravenous Mircera every 4 weeks for a total of 52 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg will be determined by the dose of ESA received prior to administration of study treatment, while subsequent doses will be adjusted to maintain hemoglobin within a country-specific target range.

Treatment:

Drug: Methoxy polyethylene glycol-epoetin beta