A Study of Subcutaneous 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:
NCT00077623
First received: February 10, 2004
Last updated: July 7, 2014
Last verified: July 2014
  Purpose

This study will assess the efficacy and safety of subcutaneous (sc) Mircera give n as maintenance treatment for renal anemia in chronic kidney disease patients o n dialysis who were previously receiving sc epoetin. The anticipated time on stu dy treatment is 1-2 years and the target sample size is 100-500 individuals.


Condition Intervention Phase
Anemia
Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
Drug: epoetin alfa or beta
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 Subcutaneous Mircera on Hemoglobin Levels in 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: 572
Study Start Date: March 2004
Study Completion Date: March 2006
Primary Completion Date: March 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 sc (starting dose) every 2 weeks
Experimental: 2 Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
30, 50 or 90 micrograms sc (starting dose) every 4 weeks
Active Comparator: 3 Drug: epoetin alfa or beta
iv 3 times weekly, 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 sc epoetin 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: NCT00077623

  Show 90 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00077623     History of Changes
Other Study ID Numbers: BA16740
Study First Received: February 10, 2004
Last Updated: July 7, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Anemia
Renal Insufficiency, Chronic
Hematologic Diseases
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Epoetin Alfa
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 26, 2014