A Study of Intravenous Mircera for the Treatment of Anemia in Dialysis Patients.

This study has been completed.
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
First received: February 12, 2004
Last updated: November 2, 2015
Last verified: November 2015
This study will assess the efficacy and safety of intravenous (iv) Mircera given as maintenance treatment for renal anemia in chronic kidney disease patients on dialysis who were previously receiving iv darbepoetin alfa. The anticipated time on study treatment is 1-2 years and the target sample size is 100-500 individuals.

Condition Intervention Phase
Drug: Darbepoetin alfa
Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Open-label Study of the Effect of Maintenance Intravenous Mircera on Hemoglobin Levels in Anemic Dialysis Patients With Chronic Kidney Disease

Resource links provided by NLM:

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Change in hemoglobin concentration [ Time Frame: Weeks 1-36 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of patients maintaining average Hb concentration within +/- 1g/dL of average baseline Hb concentration\n [ Time Frame: Weeks 29-36 ] [ Designated as safety issue: No ]
  • RBC transfusions [ Time Frame: Weeks 1-36 ] [ Designated as safety issue: No ]
  • AEs, laboratory parameters, vital signs. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment: 313
Study Start Date: March 2004
Study Completion Date: February 2006
Primary Completion Date: February 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
30, 50 or 90 micrograms iv (starting dose) every 2 weeks
Active Comparator: 2 Drug: Darbepoetin alfa
iv weekly, every 2 weeks, as prescribed


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • adult patients >=18 years of age;
  • chronic renal anemia;
  • on dialysis therapy for at least 12 weeks before screening;
  • receiving darbepoetin alfa iv for at least 8 weeks before screening.

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00077766

  Show 52 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00077766     History of Changes
Other Study ID Numbers: BA17283 
Study First Received: February 12, 2004
Last Updated: November 2, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hematologic Diseases
Darbepoetin alfa

ClinicalTrials.gov processed this record on August 22, 2016