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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

Tracking Information
First Submitted Date  ICMJE March 19, 2008
First Posted Date  ICMJE March 25, 2008
Results First Submitted Date  ICMJE June 9, 2016
Results First Posted Date  ICMJE July 22, 2016
Last Update Posted Date July 5, 2017
Actual Study Start Date  ICMJE June 30, 2008
Actual Primary Completion Date December 31, 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 9, 2016)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 19, 2008)
Proportion of patients maintaining average hemoglobin concentration during Efficacy Evaluation Period (EEP)within target range [ Time Frame: Weeks 29-36 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 9, 2016)
  • 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.
  • 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 ]
  • Mean Time Spent in Hemoglobin Range of 10-12 g/dL During Efficacy Evaluation Period (EEP) [ Time Frame: Weeks 29-36 ]
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 19, 2008)
  • Change in hemoglobin concentration between baseline and EEP [ Time Frame: Weeks 1-28 ]
  • Proportion of patients maintaining hemoglobin concentrations within range of 10-12g/dL throughout EEP [ Time Frame: Weeks 29-36 ]
  • Mean time spent in hemoglobin range of 10-12g/dL during EEP [ Time Frame: Weeks 29-36 ]
  • AEs, lab parameters [ Time Frame: Throughout study ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Subcutaneous Mircera for the Maintenance Treatment of Participants With Chronic Renal Anemia
Official Title  ICMJE 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)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Anemia
Intervention  ICMJE Drug: methoxy polyethylene glycol-epoetin beta
1.2 mcg/kg administered subcutaneously (sc) monthly for 36 weeks (initial recommended dose)
Other Name: Mircera
Study Arms  ICMJE 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.
Intervention: Drug: methoxy polyethylene glycol-epoetin beta
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 16, 2010)
35
Original Estimated Enrollment  ICMJE
 (submitted: March 19, 2008)
200
Actual Study Completion Date  ICMJE December 31, 2009
Actual Primary Completion Date December 31, 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries France,   United States
 
Administrative Information
NCT Number  ICMJE NCT00642668
Other Study ID Numbers  ICMJE ML21348
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hoffmann-La Roche
Study Sponsor  ICMJE Hoffmann-La Roche
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trials Hoffmann-La Roche
PRS Account Hoffmann-La Roche
Verification Date May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP