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A Study of Once-Monthly Subcutaneous Mircera for the Treatment of Chronic Renal Anemia in Pre-Dialysis Patients Not Currently Treated With ESA.

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00680563
First received: May 16, 2008
Last updated: June 3, 2013
Last verified: June 2013
History of Changes

May 16, 2008
June 3, 2013
April 2009
January 2010   (final data collection date for primary outcome measure)
Mean change in Hb concentration between baseline and Efficacy Evaluation Period (EEP). [ Time Frame: Week 32 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00680563 on ClinicalTrials.gov Archive Site
  • Time to achievement of response [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Percentage of patients whose Hb concentration remains within range 10.0-12.0g/dL [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Percentage of patients whose average Hb concentration is within range 10.0 - 12.0g/dL [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Mean time spent in Hb range of 10.0 - 12.0g/dL [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Percentage of patients requiring dose adjustments; incidence of RBC transfusions; time to initiation of renal replacement therapy. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study of Once-Monthly Subcutaneous Mircera for the Treatment of Chronic Renal Anemia in Pre-Dialysis Patients Not Currently Treated With ESA.
An Open Label Study of the Safety, Tolerability and Effect on Hemoglobin Levels of Once-monthly Subcutaneous Mircera in Predialysis Patients With Chronic Renal Anemia Not Currently Treated With ESA.

This single arm study will assess the efficacy and safety of subcutaneous Mircera for the correction and maintenance of hemoglobin levels in predialysis patients with renal anemia who are not currently treated with ESA. Eligible patients will receive monthly subcutaneous injections at an initial recommended dose of 1.2 micrograms/kg. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Anemia
Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
sc every month (starting dose 1.2 micrograms/kg)
Experimental: 1
Intervention: Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
4
January 2010
January 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • adult patients, >=18 years of age;
  • chronic renal anemia;
  • no ESA therapy during previous 3 months;
  • adequate iron status;
  • rapid chronic kidney disease progression.

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Brazil,   Chile,   Colombia,   Costa Rica,   Ecuador,   Guatemala,   Panama,   Peru,   Venezuela
 
NCT00680563
ML21467
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
June 2013

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