An Observational Study of Mircera in Renal Anemia Correction In Dialysed Patients During Daily Clinical Practice

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01690455
First received: September 19, 2012
Last updated: July 7, 2014
Last verified: July 2014

September 19, 2012
July 7, 2014
July 2011
June 2015   (final data collection date for primary outcome measure)
Proportion of patients who achieve a hemoglobin level of >/=10 g/dl [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01690455 on ClinicalTrials.gov Archive Site
Safety: incidence of adverse events [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
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An Observational Study of Mircera in Renal Anemia Correction In Dialysed Patients During Daily Clinical Practice
Non-interventional Study to Assess the Efficacy of Mircera for Renal Anemia Correction in Dialysis Patients in Everyday Clinical Practice in Poland.

This observational, multi-center study will evaluate the efficacy and safety of Mircera (methoxy polyethylene glycol-epoetin beta) in renal anemia correction in dialysed patients in daily clinical practice. Patient will receive Mircera acco rding to local summary of product characteristics. Data will be collected for 12 months.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample

Patients with renal anemia and on dialysis therapy

Anemia
Not Provided
Cohort
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
246
June 2015
June 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adult patients, >/=18 years of age
  • Adequate iron status
  • Signed informed consent form

Exclusion Criteria:

  • Anemia due to non-renal causes
  • Where investigator considers the patient unsuitable for inclusing for other reasons (e.g. severe co-morbidities as active bleeding, infections or cancer)
  • Pregnant or lactating female patients
  • Any contraindications against treatment with Mircera (according to local Summary of Product Characteristics)
Both
18 Years and older
No
Contact: Reference Study ID Number: ML25701 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com
Poland
 
NCT01690455
ML25701
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
July 2014

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