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STABIL Study: National Study With Mircera for Maintenance of Hemoglobin Level in Dialysis Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00642850
First received: March 19, 2008
Last updated: May 23, 2013
Last verified: May 2013
History of Changes

March 19, 2008
May 23, 2013
November 2007
September 2009   (final data collection date for primary outcome measure)
% patients maintaining average Hb conc. within the target range during the Efficacy Evaluation Period (EEP) [ Time Frame: Weeks 17-24 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00642850 on ClinicalTrials.gov Archive Site
  • Change in Hb conc. [ Time Frame: Between reference and EEP ] [ Designated as safety issue: No ]
  • % patients maintaining Hb within target range [ Time Frame: Weeks 17-24 ] [ Designated as safety issue: No ]
  • % patients requiring dose adjustments; incidence of RBC transfusions [ Time Frame: Weeks 1-24 ] [ Designated as safety issue: No ]
  • AEs, lab parameters [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
STABIL Study: National Study With Mircera for Maintenance of Hemoglobin Level in Dialysis Patients
MIRCEA in ESRD A Single Arm, Open Label Study to Assess the Efficacy, Safety and Tolerability of Once-monthly Administration of Intravenous C.E.R.A. for the Maintenance of Haemoglobin Levels in Dialysis Patients With Chronic Renal Anaemia

This single arm study will assess the efficacy, safety and tolerability of once-monthly administration of intravenous Mircera for the maintenance of hemoglobin levels in dialysis patients with chronic renal anemia. Patients will receive monthly intravenous injections of Mircera, at a starting dose of 120, 200 or 360 micrograms, according to the dose of epoetin administered in the week preceding first study drug administration. 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 iv 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
187
September 2009
September 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • adult patients, >=18 years of age;
  • chronic renal anemia;
  • continuous stable iv maintenance epoetin therapy during previous month;
  • regular long-term hemodialysis therapy with the same mode of dialysis for previous 3 months.

Exclusion Criteria:

  • transfusion of red blood cells during previous 2 months;
  • poorly controlled hypertension requiring hospitalization or interruption of erythropoietin treatment 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
Czech Republic
 
NCT00642850
ML21040
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
May 2013

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