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A Study of Once Monthly Subcutaneous Mircera in Dialysis Patients With Chronic Renal Anemia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00882713
First received: February 17, 2009
Last updated: September 19, 2012
Last verified: September 2012

February 17, 2009
September 19, 2012
February 2009
May 2012   (final data collection date for primary outcome measure)
Proportion of patients maintaining average Hb concentration within target range during Efficacy Evaluation period (EEP) [ Time Frame: Weeks 17-24 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00882713 on ClinicalTrials.gov Archive Site
  • Change in hemoglobin concentration between reference (SVP) and the EEP [ Time Frame: Weeks 1-24 ] [ Designated as safety issue: No ]
  • Proportion of patients maintaining hemoglobin concentration within the hemoglobin range 10.5-12.5g/dL throughout the EEP [ Time Frame: Weeks 17-24 ] [ Designated as safety issue: No ]
  • Mean time spent in hemoglobin range of 10.5-12.5g/dL [ Time Frame: Every 2 weeks ] [ Designated as safety issue: No ]
  • Adverse events, laboratory parameters [ Time Frame: At planned visits, to week 48 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study of Once Monthly Subcutaneous Mircera in Dialysis Patients With Chronic Renal Anemia
A Single Arm, Open Label Study to Assess the Efficacy, Safety and Tolerability of Once- Monthly Administration of Subcutaneous CERA for the Maintenance of Haemoglobin Levels in Dialysis Patients With Chronic Renal Anemia

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 dialysis patients with chronic renal anemia.Patients will receive subcutaneous Mircera at a starting dose of 120 or 200 micrograms every 4 weeks, calculated from the last weekly dose of epoetin or darbepoetin alfa 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.

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]
Subcutaneous injection every 4 weeks (starting dose of 120 or 200 micrograms, based on previous ESA therapy)
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
202
May 2012
May 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • adult patients >=18 years of age;
  • chronic renal anemia;
  • regular long-term hemodialysis or peritoneal dialysis, with same mode of dialysis for >=3 months;
  • continuous iv maintenance epoetin alfa therapy with same dosing interval during previous 2 months.

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).
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Morocco
 
NCT00882713
ML21797
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
September 2012

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