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A Study of Mircera (C.E.R.A.) in Patients With Pre-Dialysis Chronic Renal Anemia

This study is currently recruiting participants.
Verified May 2013 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01342640
First received: April 20, 2011
Last updated: May 7, 2013
Last verified: May 2013
History of Changes

April 20, 2011
May 7, 2013
July 2011
June 2013   (final data collection date for primary outcome measure)
Change in hemoglobin concentration [ Time Frame: Week 28 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01342640 on ClinicalTrials.gov Archive Site
Safety: Incidence of adverse events [ Time Frame: 32 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study of Mircera (C.E.R.A.) in Patients With Pre-Dialysis Chronic Renal Anemia
A Single Arm, Open Label, Multicenter Phase IIIb/IV Clinical Trial to Assess the Efficacy, Safety and Tolerability of Monthly Administration of C.E.R.A. for the Treatment of Not on Dialysis Chronic Renal Anemia Not Currently Treated With ESA

This single arm, open label, multicenter study will evaluate the safety and change in hemoglobin levels of Mircera (C.E.R.A.; methoxy polyethylene glycol-epoetin beta) in patients with chronic renal anemia who are not on dialysis. Patients will receive as a recommended starting dose 1.2 micrograms of Mircera subcutaneously every 4 weeks. The starting dose is dependent on the patient's weight. Dose adjustment may be required due to inadequate or excessive treatment response. The anticipated time on study treatment is 28 weeks.
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]
Recommended starting dose 1.2 micrograms/kg subcutaneously every 4 weeks (depending on patient's weight). Dose adjustment may be required in the event of inadequate or excessive treatment response.
Experimental: Single Arm
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.
 
Recruiting
90
June 2013
June 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adult patients, age >/=18 years
  • Diagnosis of chronic renal anemia
  • Not on dialysis
  • Hemoglobin concentration <10 g/dl
  • No erythropoiesis stimulating agent (ESA) therapy during the 3 months before study start
  • Estimated glomerular filtration rate (EGFR) <60 ml/min and >/=20 ml/min
  • Adequate iron status

Exclusion Criteria:

  • Transfusion of red blood cells during the previous 2 months
  • Poorly controlled hypertension
  • Significant acute or chronic bleeding, e.g. gastrointestinal bleeding
  • Active malignant disease (except non-melanoma skin cancer)
  • Hemolysis
  • Hemoglobinopathies, e.g. sickle-cell disease, thalassemia
Both
18 Years and older
No
Contact: Please reference Study ID Number: ML25300 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) genentechclinicaltrials@druginfo.com
Egypt
 
NCT01342640
ML25300
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