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A Study Comparing Mircera and Epoetin Alfa for the Treatment of Anemia in Dialysis Patients With Chronic Kidney Disease.

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ClinicalTrials.gov Identifier: NCT00422513
Recruitment Status : Terminated (Strategic decision unrelated to safety or efficacy)
First Posted : January 17, 2007
Results First Posted : December 14, 2011
Last Update Posted : December 14, 2011
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This 2 arm study will compare 'time and motion' (provider time spent on anemia management) and effect on hemoglobin (Hb) levels, of methoxy polyethylene glycol-epoetin beta (Mircera) and epoetin alfa, in anemic patients with chronic kidney disease (CKD) on hemodialysis. Patients stable on intravenous (iv) epoetin alfa will be randomized either to receive standard of care therapy (epoetin alfa (iv) 3 times weekly), or to receive Mircera 120-360 micrograms (iv), monthly. After a titration period, average time spent on anemia treatment over a 3 month period will be evaluated. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Condition or disease Intervention/treatment Phase
Anemia Drug: methoxy polyethylene glycol-epoetin beta Drug: Epoetin alfa Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 260 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Open-label Study Comparing the Pharmacoeconomic (Time and Motion) Benefit of Mircera and Epoetin Alfa in Patients With Chronic Kidney Disease (Stage V) on Dialysis.
Study Start Date : March 2007
Primary Completion Date : December 2007
Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: methoxy polyethylene glycol-epoetin beta
120-360 micrograms (iv) monthly, starting dose
Drug: methoxy polyethylene glycol-epoetin beta
120-360 micrograms intravenous (iv) monthly, starting dose
Other Name: Mircera
Active Comparator: Epoetin Alfa
As prescribed, (iv), 3 times weekly
Drug: Epoetin alfa
As prescribed, iv, 3 times weekly

Primary Outcome Measures :
  1. Time Spent on Anemia Treatment Over Evaluation Period [ Time Frame: Months 5-7 ]
    Efficacy and pharmacoeconomics analyses were not performed.

  2. Change in Hemoglobin (Hb) Concentration From Baseline to the Average Over the Evaluation Period [ Time Frame: Baseline, Months 5-7 ]
    Efficacy and pharmacoeconomics analyses were not performed.

Secondary Outcome Measures :
  1. Number of Participants Assessed for AEs [ Time Frame: Month 1 to 15 day follow up post month 7 ]
    The adverse events are captured in the adverse event and serious adverse event section of this database.

  2. The Number of Participants With Marked Laboratory Abnormalities Occurring in ≥5% of the Participants [ Time Frame: Baseline, Month 1 to Month 7 ]
    A marked laboratory abnormality was defined as a test result that was outside of the marked abnormality range and that also represented a clinically relevant change from baseline of at least a designated amount.

Information from the National Library of Medicine

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

Inclusion Criteria:

  • adult patients, >=18 years of age;
  • CKD (stage V) on outpatient hemodialysis therapy for >= 3 months;
  • CKD-related anemia treated with epoetin alfa iv 3x/week for >= 3 months;
  • average hemoglobin (Hb) 10-12 g/dL over last 3 months.

Exclusion Criteria:

  • failed renal transplant within 12 months prior to screening;
  • poorly controlled hypertension;
  • previous treatment with Mircera.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00422513

  Show 44 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00422513     History of Changes
Other Study ID Numbers: ML20336
First Posted: January 17, 2007    Key Record Dates
Results First Posted: December 14, 2011
Last Update Posted: December 14, 2011
Last Verified: November 2011

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Hematologic Diseases
Urologic Diseases
Renal Insufficiency
Epoetin Alfa