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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.
ClinicalTrials.gov Identifier:
First Posted: September 21, 2012
Last Update Posted: November 2, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hoffmann-La Roche
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.


Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Non-interventional Study to Assess the Efficacy of Mircera for Renal Anemia Correction in Dialysis Patients in Everyday Clinical Practice in Poland.

Resource links provided by NLM:

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Proportion of patients who achieve a hemoglobin level of >/=10 g/dl [ Time Frame: 12 months ]

Secondary Outcome Measures:
  • Safety: incidence of adverse events [ Time Frame: 12 months ]

Enrollment: 247
Study Start Date: July 2011
Study Completion Date: June 2015
Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with renal anemia and on dialysis therapy

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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01690455

Bartoszyce, Poland, 11-200
Bydgoszcz, Poland, 85-681
Ciechanow, Poland, 06-400
Czestochowa, Poland, 42-200
Debica, Poland, 39-200
Gliwice, Poland, 44-100
Gorzow Wielkopolski, Poland, 64-400
Grudziadz, Poland, 86-300
Hajnowka, Poland, 17-200
Jastrzębie Zdrój, Poland, 44-330
Jaworzno, Poland, 43-600
Kepno, Poland, 63-600
Konin, Poland, 62-504
Koscierzyna, Poland, 83-400
Lapy, Poland, 18-100
Lodz, Poland, 90-153
Milicz, Poland, 56-300
Pila, Poland, 64-920
Polanica Zdroj, Poland, 57-320
Radom, Poland, 26-610
Rybnik, Poland, 44-200
Rzeszow, Poland, 35-055
Rzeszow, Poland, 35-301
Sandomierz, Poland, 27-600
Siedlce, Poland, 08-110
Slupsk, Poland, 76-200
Starachowice, Poland, 27-200
Suwalki, Poland, 16-400
Swiecie, Poland, 86-100
Warszawa, Poland, 04-141
Wolomin, Poland, 05-200
Wroclaw, Poland, 51-124
Zgorzelec, Poland, 59-900
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01690455     History of Changes
Other Study ID Numbers: ML25701
First Submitted: September 19, 2012
First Posted: September 21, 2012
Last Update Posted: November 2, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
Hematologic Diseases