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

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ClinicalTrials.gov Identifier: NCT00413894
Recruitment Status : Completed
First Posted : December 20, 2006
Results First Posted : February 15, 2016
Last Update Posted : February 15, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Anemia Drug: methoxy polyethylene glycol-epoetin beta [Mircera] Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 424 participants
Intervention Model: Single Group Assignment
Masking: None (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.
Study Start Date : March 2007
Actual Primary Completion Date : October 2008
Actual Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants With Hb Levels Within 11.0-12.5 Grams Per Deciliter (g/dL) During Evaluation Phase [ Time Frame: Visits 8 to 10 (Months 6 to 8) ]
  2. Percentage of Participants With Hb Levels Within 10.0-13.0 g/dL During Evaluation Phase [ Time Frame: Visits 8 to 10 (Months 6 to 8) ]
  3. Percentage of Participants With Hb Levels Within 11.0-12.5 g/dL by Dose Modifications During Evaluation Phase [ Time Frame: Visits 8 to 10 (Months 6 to 8) ]
    Dose adjustment included increase or decrease in dose. Percentage of participants with Hb levels within 11.0-12.5 g/dL by dose adjustment categories (with dose adjustment and without dose adjustment) were reported.

  4. Percentage of Participants With Hemoglobin Levels Within 10.0-13.0 g/dL by Dose Modification During Evaluation Phase [ Time Frame: Visits 8 to 10 (Months 6 to 8) ]
    Dose adjustment included increase or decrease in dose. Percentage of participants with Hb levels within 11.0-12.5 g/dL by dose adjustment categories (with dose adjustment and without dose adjustment) were reported.


Secondary Outcome Measures :
  1. Percentage of Participants With Hb Levels Within 11.0-12.5 g/dL During Screening Phase [ Time Frame: Visits 1 to 2 (Months -2 to -1) ]
  2. Percentage of Participants With Hb Levels Within 10.0-13.0 g/dL During Screening Phase [ Time Frame: Visits 1 to 2 (Months -2 to -1) ]
  3. Percentage of Participants With Hb Levels Within 11.0-12.5 g/dL by Dose Modification During Screening Phase [ Time Frame: Visits 1 to 2 (Months -2 to -1) ]
    Dose adjustment included increase or decrease in dose. Percentage of participants with Hb levels within 11.0-12.5 g/dL by dose adjustment categories (with dose adjustment and without dose adjustment) were reported.

  4. Percentage of Participants With HbLevels Within 10.0-13.0 g/dL by Dose Modification During Screening Phase [ Time Frame: Visits 1 to 2 (Months -2 to -1) ]
    Dose adjustment included increase or decrease in dose. Percentage of participants with Hb levels within 11.0-12.5 g/dL by dose adjustment categories (with dose adjustment and without dose adjustment) were reported.

  5. Percentage of Participants With Changes Between Screening and Evaluation Phase With Respect To Hb Levels [ Time Frame: Visits 1 to 2 (Months -2 to -1) and Visits 8 to 10 (Months 6 to 8) ]

    Shifts in Hb levels between Screening and Evaluation Phase were classified as follows: Category A: Participants with Hb levels in both Screening and Evaluation Phase within 10-13 g/dL; Category B: Participants who had Hb values within 10-13 g/dL during Screening but shifted outside the range during Evaluation; Category C: Participants who had Hb values outside range during Screening but shifted to stable values (at least within 10 - 13 g/dL) during Evaluation.; Category D: Participants with less than two values available during Evaluation Phase.

    Participants could appear in only 1 category. Participants had to have 2 or 3 values within range (depending on the number of measurements available) to be counted.


  6. Percentage of Participants With Hb Fluctuations Within Evaluation Phase [ Time Frame: Visits 8 to 10 (Months 6 to 8) ]
    Hb fluctuation was defined as the deviation from individual mean Hb-value within the study phase (Evaluation Phase) and was categorized as less than or equal to (≤) ±1 g/dL, greater than (>) ±1.0 to ±1.5 g/dL, > ±1.5 to ±2.0 g/dL, and > ±2.0 g/dL. Percentage of participants within these deviation categories were reported for Evaluation Phase of the study.

  7. Percentage of Participants With Hb Fluctuations Within Screening Phase [ Time Frame: Visits 1 to 2 (Months -2 to -1) ]
    Hematology and clinical chemistry were performed partially by a central laboratory as well as by the local laboratories by means of their established methods. Normal ranges and methods as well as quality assurance certificates had to be available to the sponsor prior to the start of the study. Hb fluctuation was defined as the deviation from individual mean Hb-value within the study phase (Screening Phase) and was categorized as ≤ ±1 g/dL, >±1.0 to ±1.5 g/dL, >±1.5 to ±2.0 g/dL, and >±2.0 g/dL. Percentage of participants within these deviation categories are reported for Screening Phase of the study.

  8. Percentage of Participants Requiring Erythrocyte Transfusions [ Time Frame: Visits 1 to 10 (Months -2 to 8) ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT00413894


  Show 105 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
First Posted: December 20, 2006    Key Record Dates
Results First Posted: February 15, 2016
Last Update Posted: February 15, 2016
Last Verified: January 2016

Additional relevant MeSH terms:
Anemia
Hematologic Diseases
Epoetin Alfa
Darbepoetin alfa
Hematinics