A Study of Subcutaneous Mircera in Patients With Chronic Kidney Disease, Not on Dialysis.

Roche

Status and phase: Completed; Phase 3

Conditions: Anemia

Treatments: Drug: Mircera; Drug: Darbepoetin alfa

Study type: Interventional

Funder types: Industry

Identifiers

NCT00442702

BH20051

Details and patient eligibility

About

This 2 arm study will compare the efficacy and safety of Mircera and darbepoetin alfa in the treatment of anemia in patients with chronic kidney disease who are not on dialysis and who are receiving subcutaneous darbepoetin alfa maintenance therapy. Patients will be randomized either to remain on darbepoetin alfa therapy as per local label, or to switch to monthly subcutaneous Mircera, at a starting dose of 120, 200 or 360 micrograms, depending on the weekly dose of darbepoetin alfa administered prior to the first dose of Mircera. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Enrollment: 228 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• adult patients, >=18 years of age;
• chronic kidney disease, not requiring dialysis;
• receiving darbepoetin alfa maintenance therapy for >=8 weeks before screening, and during screening/baseline period.

Exclusion criteria

• overt gastrointestinal bleeding within 8 weeks before screening, or during screening/baseline period;
• transfusion of red blood cells within 8 weeks before screening, or during screening/baseline period;
• active malignant disease;
• previous treatment with Mircera.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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228 participants in 2 patient groups

Mircera

Experimental group

Description:

Participants received Mircera by subcutaneous injection once every month during the dose titration (7 months) and evaluation period (2 months). The starting dose was based on the weekly dose of darbepoetin alfa administered prior to the switch to Mircera, and was either 120, 200 or 360 µg Mircera per month. The dose was then adjusted to maintain Hemoglobin levels within the defined target range and also according to the need for red blood cell transfusions (due to worsening anemia), or for toxicity related to Mircera.

Treatment:

Drug: Mircera

Darbepoetin alfa

Active Comparator group

Description:

Participants continued to receive the same dose of darbepoetin alfa as before screening by subcutaneous injection once every week, once every 2 weeks or once every month as per local labeling during the dose titration (7 months) and the evaluation period (2 months).

Treatment:

Drug: Darbepoetin alfa