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A Study of Mircera in the Treatment of Anemia in Patients With Chronic Kidney Disease Not on Dialysis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00081471
Recruitment Status : Completed
First Posted : April 16, 2004
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Tracking Information
First Submitted Date  ICMJE April 13, 2004
First Posted Date  ICMJE April 16, 2004
Last Update Posted Date November 2, 2016
Study Start Date  ICMJE June 2004
Actual Primary Completion Date July 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 18, 2008)
Hemoglobin response rate [ Time Frame: Weeks 1-28 ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 23, 2013)
Hb concentration over time, time to target Hb response, incidence of RBC transfusions. Vital signs, ECG, adverse events, laboratory values\n\n [ Time Frame: Throughout study ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Mircera in the Treatment of Anemia in Patients With Chronic Kidney Disease Not on Dialysis
Official Title  ICMJE A Randomized, Open-label Study of the Effect of Subcutaneous Mircera on Hemoglobin Level/Correction in Non-dialysis Patients With Chronic Kidney Disease
Brief Summary This study will assess the efficacy and safety of subcutaneous Mircera in the treatment of renal anemia in patients with chronic kidney disease who are not on dialysis and not receiving epoetin or any other erythropoietic substance. The anticipated time on study treatment is 1-2 years and the target sample size is 100-500 individuals.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Anemia
Intervention  ICMJE
  • Drug: darbepoetin alfa
    0.45 micrograms/kg sc (starting dose) weekly
  • Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
    0.6 micrograms/kg sc (starting dose) once every 2 weeks
Study Arms  ICMJE
  • Experimental: 1
    Intervention: Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
  • Active Comparator: 2
    Intervention: Drug: darbepoetin alfa
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: January 18, 2008)
324
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE July 2006
Actual Primary Completion Date July 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • adult patients >=18 years of age;
  • chronic kidney disease;
  • anemia;
  • not on dialysis therapy;
  • not receiving epoetin.

Exclusion Criteria:

  • women who are pregnant, breastfeeding or using unreliable birth control methods;
  • administration of another investigational drug within 4 weeks before screening, or during the study period.
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 Australia,   Belgium,   Canada,   France,   Germany,   Greece,   Italy,   Netherlands,   Puerto Rico,   Spain,   Sweden,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00081471
Other Study ID Numbers  ICMJE BA16738
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
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 November 2016

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