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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01690455
First received: September 19, 2012
Last updated: October 13, 2014
Last verified: October 2014
  Purpose

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.


Condition
Anemia

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety: incidence of adverse events [ Time Frame: 12 months ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Jastrzebie 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, 35-301
Rzeszow, Poland, 35-055
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
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01690455     History of Changes
Other Study ID Numbers: ML25701
Study First Received: September 19, 2012
Last Updated: October 13, 2014
Health Authority: Poland: Pharmacovigilance Department of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

Additional relevant MeSH terms:
Anemia
Hematologic Diseases

ClinicalTrials.gov processed this record on October 19, 2014