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A Study of Once Monthly Subcutaneous Mircera in Patients With Chronic Renal Anemia Not on Dialysis

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ClinicalTrials.gov Identifier: NCT00922116
Recruitment Status : Completed
First Posted : June 17, 2009
Results First Posted : December 9, 2015
Last Update Posted : July 13, 2017
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Tracking Information
First Submitted Date  ICMJE June 16, 2009
First Posted Date  ICMJE June 17, 2009
Results First Submitted Date  ICMJE November 4, 2015
Results First Posted Date  ICMJE December 9, 2015
Last Update Posted Date July 13, 2017
Actual Study Start Date  ICMJE April 30, 2009
Actual Primary Completion Date November 30, 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 4, 2015)
Percentage of Participants Maintaining Average Hemoglobin Concentration Within the Target Range During the Efficacy Evaluable Period (EEP) [ Time Frame: EEP (Weeks 17 to 24) ]
The target hemoglobin was defined as the mean of the three assessments recorded at Weeks -4, -2, and 0 (Stability Verification Period [SVP]). EEP was an 8 week period from Weeks 17 to 24. The 95 percent (%) confidence interval (CI) was estimated using Clopper-Pearson.
Original Primary Outcome Measures  ICMJE
 (submitted: June 16, 2009)
Proportion of patients maintaining average hemoglobin concentration within target range during Efficacy Evaluation Period (EEP) [ Time Frame: Weeks 17-24 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 4, 2015)
  • Change in Hemoglobin Concentration Between SVP and the EEP [ Time Frame: SVP (Baseline), and EEP (Weeks 17 to 24) ]
    Baseline hemoglobin was defined as the mean of the three assessments recorded at Weeks -4, -2, and 0 (SVP). EEP hemoglobin was defined as the mean of the hemoglobin assessments during EEP. EEP was an 8 week period from Weeks 17 to 24.
  • Percentage of Participants Maintaining Hemoglobin Concentration Within Hemoglobin Range 10.0 to 12.0 g/dL Throughout the EEP [ Time Frame: EEP (Weeks 17 to 24) ]
    EEP was an 8 week period from Weeks 17 to 24. The 95% CI was estimated using Clopper-Pearson.
  • Percentage of Participants Who Required Dose Adjustments During Dose Titration Period (DTP) and EEP [ Time Frame: Weeks 1 to 24 ]
    DTP was a 16- week period from Week 1 to Week 16, EEP was an 8-week period from Weeks 17 to 24. Dose adjustment was assessed during entire Week 1 to 24.
  • Time Spent in Hemoglobin Range of 10.0 to 12.0 g/dL During DTP and EEP [ Time Frame: Weeks 1 to 24 ]
    DTP was a 16- week period from Week 1 to Week 16, EEP was an 8-week period from Weeks 17 to 24. Dose adjustment was assessed during entire Week 1 to 24.
  • Average Dose of Mircera Per Month [ Time Frame: Weeks 0-4, 4-8, 8-12, 12-16, 16-20, and 20-24 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 16, 2009)
Adverse events; laboratory parameters [ Time Frame: At planned visits, to week 28 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Once Monthly Subcutaneous Mircera in Patients With Chronic Renal Anemia Not on Dialysis
Official Title  ICMJE A Single Arm, Open Label Study to Assess the Efficacy, Safety and Tolerability of Once-monthly Administration of Subcutaneous Mircera® for the Maintenance of Haemoglobin Levels in Patients With Chronic Renal Anaemia Who Are Not on Dialysis
Brief Summary This single arm study will assess the efficacy, safety and tolerability of once monthly administration of subcutaneous Mircera for the maintenance of hemoglobin levels in patients with chronic renal anemia not on dialysis.Patients will receive sc Mircera at a starting dose of 100, 120, 200 or 360 micrograms every 4 weeks, calculated from the last weekly dose of ESA previously administered. Subsequent doses will be adjusted to maintain hemoglobin levels within the target range. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 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 [Mircera]
sc every month (starting dose of 100, 120, 150 or 200 micrograms based on previous ESA therapy)
Study Arms  ICMJE Experimental: 1
Intervention: Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
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: March 31, 2014)
191
Original Estimated Enrollment  ICMJE
 (submitted: June 16, 2009)
200
Actual Study Completion Date  ICMJE November 30, 2010
Actual Primary Completion Date November 30, 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • adult patients, >=18 years of age;
  • chronic renal anemia;
  • continuous maintenance ESA therapy with the same dosing interval during the previous month, and no change in totally weekly dose.

Exclusion Criteria:

  • transfusion of red blood cells during previous 2 months;
  • poorly controlled hypertension;
  • significant acute or chronic bleeding;
  • active malignant disease (except non-melanoma skin cancer).
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 Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00922116
Other Study ID Numbers  ICMJE ML22285
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