A Study of Subcutaneous Mircera for the Maintenance Treatment of Pre-Dialysis Patients With Chronic Renal Anemia.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00517881
First received: August 16, 2007
Last updated: November 4, 2013
Last verified: November 2013

August 16, 2007
November 4, 2013
July 2007
November 2009   (final data collection date for primary outcome measure)
Percentage of patients maintaining average Hb concentration in target range during evaluation period [ Time Frame: Weeks 17-24 ] [ Designated as safety issue: No ]
Proportion of patients maintaining average Hb concentration within target range of 10.5-12.5g/dL during evaluation period.
Complete list of historical versions of study NCT00517881 on ClinicalTrials.gov Archive Site
  • Change in Hb concentration and percentage of patients maintaining Hb concentration in target range during evaluation period [ Time Frame: Weeks 17-24 ] [ Designated as safety issue: No ]
  • Mean time spent 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 ]
Efficacy:Change in Hb conc. over evaluation period; % of pts. maintaining Hb conc in target range ; mean time spent in Hb target range; % of pts needing dose adjustments; incidence of RBC transfusions. safety: AEs, lab parameters
Not Provided
Not Provided
 
A Study of Subcutaneous Mircera for the Maintenance Treatment of Pre-Dialysis Patients With Chronic Renal Anemia.
An Open Label Study to Assess the Maintenance of Hemoglobin Levels, Safety and Tolerability of Once Monthly Administration of Subcutaneous Mircera in Pre-dialysis Patients With Chronic Renal Anemia

This single arm study will assess the efficacy and safety of subcutaneous Mircera for maintenance of hemoglobin levels in pre-dialysis patients with chronic renal anemia. Patients currently receiving maintenance treatment with subcutaneous darbepoetin alfa will receive monthly subcutaneous injections of Mircera with the starting dose (120, 200 or 360 micrograms) derived from the dose of darbepoetin alfa or epoetin alfa 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
39
November 2009
November 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • adult patients, >=18 years of age;
  • chronic renal anemia;
  • continuous subcutaneous maintenance darbepoetin alfa therapy with same dosing interval during previous 2 months.

Exclusion Criteria:

  • transfusion of red blood cells during previous 2 months;
  • poorly controlled hypertension requiring hospitalization or interruption of darbepoetin alfa treatment in previous 6 months;
  • acute or chronic bleeding.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT00517881
ML20944
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
November 2013

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