A Study of Once Monthly Subcutaneous Mircera in Patients With Chronic Renal Anemia Not on Dialysis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00922116
First received: June 16, 2009
Last updated: April 7, 2014
Last verified: April 2014

June 16, 2009
April 7, 2014
April 2009
November 2010   (final data collection date for primary outcome measure)
Proportion of patients maintaining average hemoglobin concentration within target range during Efficacy Evaluation Period (EEP) [ Time Frame: Weeks 17-24 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00922116 on ClinicalTrials.gov Archive Site
Adverse events; laboratory parameters [ Time Frame: At planned visits, to week 28 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study of Once Monthly Subcutaneous Mircera in Patients With Chronic Renal Anemia Not on Dialysis
A Single Arm, Open Label Study to Assess the Efficacy, Safety and Tolerability of Once-monthly Administration of Subcutaneous Mircera® for the Maintenance of Haemoglobin Levels in Patients With Chronic Renal Anaemia Who Are Not on Dialysis

This single arm study will assess the efficacy, safety and tolerability of once monthly administration of subcutaneous Mircera for the maintenance of hemoglobin levels in patients with chronic renal anemia not on dialysis.Patients will receive sc Mircera at a starting dose of 100, 120, 150 or 200 micrograms every 4 weeks, calculated from the last weekly dose of ESA previously administered. Subsequent doses will be adjusted to maintain hemoglobin levels within the target range. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Not Provided
Interventional
Phase 4
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]
sc every month (starting dose of 100, 120, 150 or 200 micrograms based on previous ESA therapy)
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
191
November 2010
November 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • adult patients, >=18 years of age;
  • chronic renal anemia;
  • continuous maintenance ESA therapy with the same dosing interval during the previous month, and no change in totally weekly dose.

Exclusion Criteria:

  • transfusion of red blood cells during previous 2 months;
  • poorly controlled hypertension;
  • significant acute or chronic bleeding;
  • active malignant disease (except non-melanoma skin cancer).
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT00922116
ML22285
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
April 2014

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