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A Study of Subcutaneous Mircera for the Maintenance Treatment of Participants With Chronic Renal Anemia

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ClinicalTrials.gov Identifier: NCT00642668
Recruitment Status : Completed
First Posted : March 25, 2008
Results First Posted : July 22, 2016
Last Update Posted : July 5, 2017
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This single arm study assessed the efficacy and safety of subcutaneous methoxy polyethylene glycol-epoetin beta (Mircera), a continuous erythropoietin receptor activator (C.E.R.A.), for correction and/or maintenance of hemoglobin levels in participants with chronic kidney disease and renal anemia, who were not treated with erythropoiesis-stimulating agents (ESA) or on dialysis. Eligible participants received monthly subcutaneous injections of methoxy polyethylene glycol-epoetin beta at an initial recommended dose of 1.2 micrograms/kilogram (mcg/kg). The anticipated time on study treatment was 3-10 months, and the target sample size was 200 individuals.

Condition or disease Intervention/treatment Phase
Anemia Drug: methoxy polyethylene glycol-epoetin beta Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Subcutaneous Treatment of Anemia in Patients With a GFR Below 45 ml/Min/1.73m2 Through Injections With Mircera as Low Frequent as Once Monthly (STABILO)
Actual Study Start Date : June 30, 2008
Actual Primary Completion Date : December 31, 2009
Actual Study Completion Date : December 31, 2009


Arm Intervention/treatment
Experimental: Methoxy Polyethylene Glycol-Epoetin Beta
Participants received methoxy polyethylene glycol-epoetin beta treatment monthly for 36 weeks with an efficacy evaluation period (EEP) during weeks 29-36 and followed by a 4 week follow-up period.
Drug: methoxy polyethylene glycol-epoetin beta
1.2 mcg/kg administered subcutaneously (sc) monthly for 36 weeks (initial recommended dose)
Other Name: Mircera




Primary Outcome Measures :
  1. Percentage of Participants Maintaining Average Hemoglobin Concentration During Efficacy Evaluation Period (EEP) Within Target Range [ Time Frame: Weeks 29-36 ]
    The EEP was week 29 through week 36. The target range for average hemoglobin concentration was 10.0 - 12.0 g/dL.


Secondary Outcome Measures :
  1. Change From Baseline in Hemoglobin Concentration to Efficacy Evaluation Period (EEP) [ Time Frame: Weeks 0-36 ]
    The mean change Baseline Hemoglobin to the time adjusted average of Hemoglobin during the EEP.

  2. Percentage of Participants Maintaining Hemoglobin Concentrations Within Range of 10-12 Grams/Deciliter (g/dL) Throughout Efficacy Evaluation Period (EEP) [ Time Frame: Weeks 29-36 ]
  3. Mean Time Spent in Hemoglobin Range of 10-12 g/dL During Efficacy Evaluation Period (EEP) [ Time Frame: Weeks 29-36 ]
  4. Percentage of Participants With Adverse Events [ Time Frame: Weeks 1-40 ]
    An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.



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

Inclusion Criteria:

  • Adult participants, >=18 years of age;
  • Chronic renal anemia;
  • No ESA therapy during previous 3 months.

Exclusion Criteria:

  • Transfusion of red blood cells during previous 2 months;
  • Poorly controlled hypertension requiring hospitalization in previous 6 months;
  • Significant acute or chronic bleeding.

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): NCT00642668


Locations
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Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00642668    
Other Study ID Numbers: ML21348
First Posted: March 25, 2008    Key Record Dates
Results First Posted: July 22, 2016
Last Update Posted: July 5, 2017
Last Verified: May 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Anemia
Hematologic Diseases
Epoetin Alfa
Hematinics