A Study of Intravenous Mircera for the Treatment of Anemia in Dialysis Patients.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00413894
First received: December 19, 2006
Last updated: August 4, 2014
Last verified: August 2014

December 19, 2006
August 4, 2014
February 2007
April 2009   (final data collection date for primary outcome measure)
Percentage of patients in a defined Hb range and percentage of patients with or without dose adjustments, during evaluation period. [ Time Frame: Weeks 17-24 ] [ Designated as safety issue: No ]
Percentage of patients in a defined Hb range during evaluation period; percentage of patients with or without dose adjustments during evaluation period.
Complete list of historical versions of study NCT00413894 on ClinicalTrials.gov Archive Site
  • AEs, laboratory parameters, vital signs. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Percentage of patients in a defined Hb range, and percentage of patients with or without dose adjustments. [ Time Frame: During screening period ] [ Designated as safety issue: No ]
  • Incidence of RBC transfusions [ Time Frame: Weeks 0-24 ] [ Designated as safety issue: No ]
Efficacy: percentage of patients in a defined range, and with or without dose adjustments, during screening period; incidence of RBC transfusions. Safety: AEs, lab parameters, vital signs.
Not Provided
Not Provided
 
A Study of Intravenous Mircera for the Treatment of Anemia in Dialysis Patients.
An Open Label Study of the Effect of Intravenous Mircera on Hemoglobin Levels in Anemic Patients With Chronic Kidney Disease Who Are on Dialysis, and Who Have Previously Received Epoetin Alfa or Beta or Darbepoetin Alfa Treatment.

This single arm study will assess the efficacy and safety of intravenous Mircera

, administered with pre-filled syringes, for the treatment of anemia in patients with chronic kidney disease who are on dialysis, and who have previously receiv ed treatment with epoetin alfa or beta or darbepoetin alfa. Patients will receiv e monthly intravenous injections of Mircera, with the starting dose derived from the dose of epoetin alfa or beta or darbepoetin they were receiving in the week preceding study start. The anticipated time on study treatment is 3-12 months, and the target sample size is 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]
iv monthly, with starting dose based on previous dose of epoetin alfa or beta or darbepoetin alfa
Experimental: 1
Intervention: Drug: methoxy polyethylene glycol-epoetin beta [Mircera]
Fliser D, Kleophas W, Dellanna F, Winkler RE, Backs W, Kraatz U, Fassbinder W, Wizemann V, Strack G. Evaluation of maintenance of stable haemoglobin levels in haemodialysis patients converting from epoetin or darbepoetin to monthly intravenous C.E.R.A.: the MIRACEL study. Curr Med Res Opin. 2010 May;26(5):1083-9. doi: 10.1185/03007991003666652. Erratum in: Curr Med Res Opin. 2010 Aug;26(8):1826. Dellana, F [corrected to Dellanna, F].

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
661
April 2009
April 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • adult patients, >=18 years of age;
  • chronic renal anemia;
  • longterm hemodialysis for >=12 weeks before screening;
  • baseline Hb between 10 and 13g/dL;
  • iv or sc maintenance epoetin alfa or beta or darbepoetin alfa therapy with same dosing interval for >=4 weeks before screening.

Exclusion Criteria:

  • acute or chronic bleeding within 8 weeks prior to screening;
  • transfusion of red blood cells within 8 weeks prior to screening;
  • poorly controlled hypertension necessitating interruption of erythropoetin treatment in previous 6 months;
  • previous treatment with Mircera.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00413894
ML20572
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
August 2014

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