A Study of Mircera in Renal Anemia Among Filipino Chronic Kidney Disease Patients

Roche

Status and phase: Completed; Phase 4

Conditions: Anemia

Treatments: Drug: methoxy polyethylene glycol-epoetin beta [Mircera]

Study type: Interventional

Funder types: Industry

Identifiers

NCT00922610

ML21983

Details and patient eligibility

About

This study will assess the efficacy and safety of once monthly administration of Mircera in Filipino patients with chronic kidney disease who are either on dialysis or predialysis, and not receiving erythropoiesis stimulating agents.Patients will receive Mircera at a starting dose of 0.6 micrograms/kg sc every 2 weeks, with dose adjustments until a target hemoglobin level is achieved, and then dosing will continue every 4 weeks. The anticipated time on study treatment is 3-12 months, and the target sample is <100 individuals.

Enrollment: 28 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• adult patients, >=18 years of age;
• chronic kidney disease;
• anemia (Hb >8 and <11 g/dL);
• regular dialysis or predialysis, not treated with ESA.

Exclusion criteria

• transfusion of red blood cells during previous 8 weeks;
• poorly controlled hypertension;
• overt gastrointestinal bleeding, or other bleeding necessitating transfusion during previous 8 weeks;
• active malignant disease (except melanoma of skin).

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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28 participants in 1 patient group

1

Experimental group

Treatment:

Drug: methoxy polyethylene glycol-epoetin beta [Mircera]