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

This study has been terminated.
(Strategic decision unrelated to safety or efficacy)
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00422513
First received: January 15, 2007
Last updated: November 9, 2011
Last verified: November 2011
History of Changes
  Purpose

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 Intervention Phase
Anemia
 Drug: methoxy polyethylene glycol-epoetin beta
Drug: Epoetin alfa
 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 Comparing the Pharmacoeconomic (Time and Motion) Benefit of Mircera and Epoetin Alfa in Patients With Chronic Kidney Disease (Stage V) on Dialysis.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Time Spent on Anemia Treatment Over Evaluation Period [ Time Frame: Months 5-7 ] [ Designated as safety issue: No ]
    Efficacy and pharmacoeconomics analyses were not performed.

  • Change in Hemoglobin (Hb) Concentration From Baseline to the Average Over the Evaluation Period [ Time Frame: Baseline, Months 5-7 ] [ Designated as safety issue: No ]
    Efficacy and pharmacoeconomics analyses were not performed.


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

  • The Number of Participants With Marked Laboratory Abnormalities Occurring in ≥5% of the Participants [ Time Frame: Baseline, Month 1 to Month 7 ] [ Designated as safety issue: No ]
    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.


Enrollment: 260
Study Start Date: March 2007
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  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;
  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00422513

  Show 44 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: NCT00422513     History of Changes
Other Study ID Numbers: ML20336
Study First Received: January 15, 2007
Results First Received: March 29, 2011
Last Updated: November 9, 2011
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 19, 2013