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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00077766
First received: February 12, 2004
Last updated: October 6, 2014
Last verified: October 2014
  Purpose

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 tim e on study treatment is 1-2 years and the target sample size is 100-500 individu als.


Condition Intervention Phase
Anemia
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

No publications provided by Hoffmann-La Roche

Additional 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: October 6, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Anemia
Hematologic Diseases
Darbepoetin alfa
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 19, 2014