Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

A Study of Monthly Subcutaneous Mircera for the Treatment of Chronic Renal Anemia in Predialysis Patients Not Treated With ESA.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00661388
First received: April 16, 2008
Last updated: July 1, 2013
Last verified: July 2013

April 16, 2008
July 1, 2013
August 2008
October 2010   (final data collection date for primary outcome measure)
Mean change in Hb concentration between baseline and Efficacy Evaluation Period (EEP) [ Time Frame: Weeks 29-36 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00661388 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 10.0-12.0 g/dL [ Time Frame: Weeks 29-36 ] [ Designated as safety issue: No ]
  • Percentage of patients whose average Hb concentration is within range 10.0-12.0 g/dL [ Time Frame: Weeks 29-36 ] [ Designated as safety issue: No ]
  • Mean time spent in Hb range of 10.0-12.0 g/dL [ Time Frame: Weeks 29-36 ] [ Designated as safety issue: No ]
  • Percentage of patients requiring dose adjustments; incidence of RBC transfusions. [ Time Frame: Weeks 0-36 ] [ Designated as safety issue: No ]
  • AEs, laboratory parameters. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Time to achievement of response [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Percentage of patients whose Hb concentration remains within range 10.0-12.0 g/dL [ Time Frame: Weeks 29-36 ] [ Designated as safety issue: No ]
  • Percentage of patients whose average Hb concentration is within range 10.0-12.0 g/dL [ Time Frame: Weeks 29-36 ] [ Designated as safety issue: No ]
  • Mean time spent in Hb range of 10.0-12.0 g/dL [ Time Frame: Weeks 29-36 ] [ Designated as safety issue: No ]
  • Percentage of patients requiring dose adjustments; incidence of red blood cells (RBC) transfusions. [ Time Frame: Weeks 0-36 ] [ Designated as safety issue: No ]
  • AEs, laboratory parameters. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Study of Monthly Subcutaneous Mircera for the Treatment of Chronic Renal Anemia in Predialysis Patients Not Treated With ESA.
An Open Label Study of the Safety, Tolerability and Effect on Hemoglobin Levels of 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 of Mircera 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.
 
Completed
75
October 2010
October 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • adult patients, >=18 years of age;
  • chronic renal anemia;
  • predialysis stage;
  • 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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Turkey
 
NCT00661388
ML21524
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
July 2013

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