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A Study of Subcutaneous Mircera for the Maintenance Treatment of Patients With Chronic Renal Anemia Not on Dialysis.

This study has been completed.
Sponsor:
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00642304
First received: March 19, 2008
Last updated: September 21, 2011
Last verified: September 2011
History of Changes

March 19, 2008
September 21, 2011
March 2008
September 2009   (final data collection date for primary outcome measure)
Percentage of patients maintaining average Hb concentration within target range of 10.5-12.5g/dL during evaluation period. [ Time Frame: Weeks 17-24 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00642304 on ClinicalTrials.gov Archive Site
  • Change in Hb concentration, and percentage of patients maintaining Hb concentration in target range throughout evaluation period. [ Time Frame: Week 17-24 ] [ Designated as safety issue: No ]
  • Mean time in target range; percentage of patients needing dose adjustments; incidence of RBC transfusions. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • AEs, laboratory parameters. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study of Subcutaneous Mircera for the Maintenance Treatment of Patients With Chronic Renal Anemia Not on Dialysis.
A Single Arm Open Label Study to Assess Efficacy, Safety and Tolerability of Once-monthly Administration of Subcutaneously Mircera for the Maintenance of Hemoglobin Levels in Patients With Chronic Renal Anemia Not on Dialysis

This single arm study will assess the efficacy and safety of subcutaneous Mircera when administered for the maintenance of hemoglobin levels in patients with chronic renal anemia, not on dialysis. Patients currently receiving maintenance treatment with subcutaneous darbepoetin alfa or epoetin beta will receive monthly injections of Mircera, with the starting dose (120, 200 or 360 micrograms s.c.) derived from the dose of darbepoetin alfa or epoetin beta they were receiving in the week preceding study start. 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]
120, 200 or 360 micrograms sc monthly (starting dose)
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
22
September 2009
September 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • adult patients, >=18 years of age;
  • chronic renal anemia;
  • stable darbepoetin alfa or epoetin beta therapy for past 8 weeks.

Exclusion Criteria:

  • transfusion of red blood cells during previous 8 weeks;
  • poorly controlled hypertension requiring interruption of epoetin treatment in previous 6 months;
  • acute or chronic bleeding requiring therapy within previous 8 weeks.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT00642304
ML20937
Not Provided
Disclosures Group, Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
September 2011

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