Full Text View
Tabular View
No Study Results Posted
Related Studies
A Study of Subcutaneous Mircera for the Treatment of Anemia in Pre-Dialysis Patients.
This study is ongoing, but not recruiting participants.
Study NCT00576628   Information provided by Hoffmann-La Roche
First Received: December 18, 2007   Last Updated: November 17, 2009   History of Changes

December 18, 2007
November 17, 2009
April 2008
 
Change in Hb concentration between screening and evaluation period [ Time Frame: Weeks 29-36 ] [ Designated as safety issue: No ]
Change in Hb concentration between screening and evaluation period.
Complete list of historical versions of study NCT00576628 on ClinicalTrials.gov Archive Site
  • Percentage of patients maintaining average Hb concentration of 11.0-13.0g/dL throughout evaluation period. [ Time Frame: Weeks 29-36 ] [ Designated as safety issue: No ]
  • Mean time spent in target Hb range; mean number of months/subject requiring any dose adjustment; RBC transfusions. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • AEs, laboratory parameters. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Efficacy: Percentage of patients maintaining average Hb conc. of 11.0-13.0g/dL throughout evaluation period; mean time spent in target Hb range; mean no. of months/subject requiring any dose adjustment; RBC transfusions. Safety: AEs, lab parameters.
 
A Study of Subcutaneous Mircera for the Treatment of Anemia in Pre-Dialysis Patients.
An Open Label Study to Assess the Effect on Anemia Correction, Maintenance of Haemoglobin Levels, Safety and Tolerability of Monthly Administration of Subcutaneous Mircera in Pre-dialysis Patients With Chronic Renal Anemia Not Currently Treated With ESA.

This single arm study will assess the efficacy, safety and tolerability of subcutaneous Mircera for correction of anemia and maintenance of hemoglobin levels in patients with chronic kidney disease who are not on dialysis and are not treated with ESA. Eligible patients will receive Mircera by monthly subcutaneous injections, dependent on body weight (with a recommended starting dose of 1.2 micrograms/kg). 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.
 
Active, not recruiting
200
August 2010
 

Inclusion Criteria:

  • adult patients, >=18 years of age;
  • chronic renal anemia, with no need for dialysis expected in next 3 months;
  • adequate iron status.

Exclusion Criteria:

  • previous epoetin therapy within 12 weeks prior to treatment;
  • transfusion of red blood cells during 2 months prior to screening;
  • significant acute or chronic bleeding such as overt gastrointestinal bleeding;
  • hemolysis;
  • folic acid and vitamin B 12 deficiency.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Russian Federation
 
NCT00576628
Disclosures Group, Hoffmann-La Roche
ML20978
Hoffmann-La Roche
 
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
November 2009

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