A Study of Subcutaneous Mircera for the Treatment of Anemia in Pre-Dialysis Participants With Chronic Kidney Disease.

Roche

Status and phase: Terminated; Phase 3

Conditions: Anemia

Treatments: Drug: Methoxy Polyethylene Glycol-epoetin Beta

Study type: Interventional

Funder types: Industry

Identifiers

NCT00462384

ML20659

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 on dialysis and are not treated with erythropoiesis-stimulating agents (ESA). Eligible participants will receive Mircera by monthly subcutaneous injections, dependent on body weight (with a starting dose of 1.2 micrograms/kilogram [mcg/kg]). The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Enrollment: 39 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• chronic kidney disease, stage 3 or 4;
• anemia (baseline hemoglobin between 9 and 11 grams per deciliter [g/dL]).

Exclusion criteria

• previous therapy with ESA within 12 weeks prior to screening;
• significant acute or chronic bleeding such as overt gastrointestinal bleeding;
• red blood cell transfusions within 8 weeks before screening;
• 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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39 participants in 1 patient group

Methoxy Polyethylene Glycol-epoetin Beta

Experimental group

Description:

Methoxy polyethylene glycol-epoetin beta will be administered subcutaneously every 4 weeks (at Weeks 4, 8, 12, 16, 20, 24, 28 and 32). The starting dose will be 1.2 micrograms per kilogram (mcg/kg) body weight. Thereafter, throughout the duration of study the dose adjustments will be performed depending on the hemoglobin value.

Treatment:

Drug: Methoxy Polyethylene Glycol-epoetin Beta