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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:
NCT00413894
First received: December 19, 2006
Last updated: March 2, 2015
Last verified: March 2015
History of Changes
  Purpose

This single arm study will assess the efficacy and safety of intravenous Mircera, administered with pre-filled syringes, for the treatment of anemia in patients with chronic kidney disease who are on dialysis, and who have previously received treatment with epoetin alfa or beta or darbepoetin alfa. Patients will receive monthly intravenous injections of Mircera, with the starting dose derived from the dose of epoetin alfa or beta or darbepoetin they were receiving in the week preceding study start. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.


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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label Study of the Effect of Intravenous Mircera on Hemoglobin Levels in Anemic Patients With Chronic Kidney Disease Who Are on Dialysis, and Who Have Previously Received Epoetin Alfa or Beta or Darbepoetin Alfa Treatment.

Resource links provided by NLM:

MedlinePlus related topics: Anemia Dialysis
U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Percentage of patients in a defined Hb range and percentage of patients with or without dose adjustments, during evaluation period. [ Time Frame: Weeks 17-24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of patients in a defined Hb range, and percentage of patients with or without dose adjustments. [ Time Frame: During screening period ] [ Designated as safety issue: No ]
  • Incidence of RBC transfusions [ Time Frame: Weeks 0-24 ] [ Designated as safety issue: No ]
  • AEs, laboratory parameters, vital signs. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Enrollment: 661
Study Start Date: February 2007
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
iv monthly, with starting dose based on previous dose of epoetin alfa or beta or darbepoetin alfa

  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;
  • longterm hemodialysis for >=12 weeks before screening;
  • baseline Hb between 10 and 13g/dL;
  • iv or sc maintenance epoetin alfa or beta or darbepoetin alfa therapy with same dosing interval for >=4 weeks before screening.

Exclusion Criteria:

  • acute or chronic bleeding within 8 weeks prior to screening;
  • transfusion of red blood cells within 8 weeks prior to screening;
  • poorly controlled hypertension necessitating interruption of erythropoetin treatment in previous 6 months;
  • previous treatment with Mircera.
  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: NCT00413894

  Show 105 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: NCT00413894     History of Changes
Other Study ID Numbers: ML20572
Study First Received: December 19, 2006
Last Updated: March 2, 2015
Health Authority: Germany: Ethics Commission

ClinicalTrials.gov processed this record on March 03, 2015