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

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ClinicalTrials.gov Identifier: NCT01690455
Recruitment Status : Completed
First Posted : September 21, 2012
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
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.

Condition or disease
Anemia

Study Type : Observational
Actual Enrollment : 247 participants
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.
Study Start Date : July 2011
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia

Group/Cohort
Cohort



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

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


Information from the National Library of Medicine

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

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)

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


Locations
Poland
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
Investigators
Study Director: Clinical Trials Hoffmann-La Roche

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

Additional relevant MeSH terms:
Anemia
Hematologic Diseases