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A Study of Intravenous Mircera in Hemodialysis Patients With Chronic Renal Anemia
This study is currently recruiting participants.
Study NCT00661505   Information provided by Hoffmann-La Roche
First Received: April 16, 2008   Last Updated: October 15, 2009   History of Changes

April 16, 2008
October 15, 2009
May 2008
 
% patients maintaining mean Hb conc. within target range during the Efficacy Evaluation Period (EEP) [ Time Frame: Weeks 16-24 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00661505 on ClinicalTrials.gov Archive Site
  • Change in mean Hb conc. [ Time Frame: Between reference and EEP ] [ Designated as safety issue: No ]
  • % patients maintaining Hb within target range [ Time Frame: Weeks 16-24 ] [ Designated as safety issue: No ]
  • % patients requiring dose adjustments; incidence of RBC transfusions [ Time Frame: Weeks 0-24 ] [ Designated as safety issue: No ]
  • AEs, lab parameters [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Same as current
 
A Study of Intravenous Mircera in Hemodialysis Patients With Chronic Renal Anemia
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 Haemodialysis 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 hemodialysis patients with chronic renal anemia. Patients will receive 4-weekly intravenous injections of Mircera, at a starting dose of 120, 200 or 360 micrograms. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

 
Phase III
Interventional
Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Anemia
Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
200
September 2010
 

Inclusion Criteria:

  • adult patients, >= 18 years of age;
  • chronic renal anemia;
  • continuous stable iv or sc maintenance epoetin therapy during previous 4 weeks;
  • 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 epoetin treatment in previous 6 months;
  • significant acute or chronic bleeding.
Both
18 Years and older
No
Contact: Please reference Study ID Number: ML21096 888-662-6728 (U.S. Only) genentechclinicaltrials@druginfo.com
Turkey
 
NCT00661505
Disclosures Group, Hoffmann-La Roche
ML21096
Hoffmann-La Roche
 
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
October 2009

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