A Study of Subcutaneous Mircera in Participants With Chronic Kidney Disease Not Treated With ESA or on Dialysis (MERCUR)

Roche

Status and phase: Completed; Phase 3

Conditions: Anemia

Treatments: Drug: Methoxy polyethylene glycol-epoetin beta

Study type: Interventional

Funder types: Industry

Identifiers

NCT00559637

ML20888

2007-000126-46 (EudraCT Number)

Details and patient eligibility

About

This single arm study will assess the efficacy and safety of subcutaneous Mircera for correction of anemia in participants with chronic kidney disease who are not treated with erythropoiesis stimulating agent (ESA) and not on dialysis. Eligible participants will receive Mircera by monthly subcutaneous injections. The initial dose, based on body weight, will be 1.2 micrograms/kilogram (mcg/kg). The anticipated time on study treatment is 9-11 months, and the target sample size is 100-500 individuals.

Enrollment: 184 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• chronic renal anemia;
• hemoglobin value less than or equal to (<=) 10.5 grams/deciliter (g/dL).

Exclusion criteria

• prior ESA therapy during previous 3 months;
• acute or chronic bleeding requiring therapy during previous 2 months;
• transfusion of red blood cells during previous 2 months;
• 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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184 participants in 1 patient group

Methoxy polyethylene glycol-epoetin beta

Experimental group

Description:

Methoxy polyethylene glycol-epoetin beta will be administered subcutaneously once a month. The starting dose will be 1.2 mcg/kg of body weight. Further dose adjustments will be performed during the study depending on the hemoglobin value. Total duration of treatment will be 9 months for all participants in the study and up to 11 months for participants who will be shifted to the dialysis.

Treatment:

Drug: Methoxy polyethylene glycol-epoetin beta