A Study of Mircera in the Treatment of Anemia in Patients With Chronic Kidney Disease Not on Dialysis

Roche

Status and phase: Completed; Phase 3

Conditions: Anemia

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00081471

BA16738

Details and patient eligibility

About

This study will assess the efficacy and safety of subcutaneous Mircera in the treatment of renal anemia in patients with chronic kidney disease who are not on dialysis and not receiving epoetin or any other erythropoietic substance. The anticipated time on study treatment is 1-2 years and the target sample size is 100-500 individuals.

Enrollment: 324 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• adult patients >=18 years of age;
• chronic kidney disease;
• anemia;
• not on dialysis therapy;
• not receiving epoetin.

Exclusion criteria

• women who are pregnant, breastfeeding or using unreliable birth control methods;
• administration of another investigational drug within 4 weeks before screening, or during the study period.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

324 participants in 2 patient groups

1

Experimental group

Treatment:

Drug: methoxy polyethylene glycol-epoetin beta [Mircera]

2

Active Comparator group

Treatment:

Drug: darbepoetin alfa