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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01690455
First received: September 19, 2012
Last updated: September 1, 2016
Last verified: September 2016

September 19, 2012
September 1, 2016
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
Not Provided
Not Provided
 
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 according 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
247
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   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Poland
 
NCT01690455
ML25701
Not Provided
Not Provided
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
September 2016

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