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
  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 ]

Estimated Enrollment: 246
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

Contacts
Contact: Reference Study ID Number: ML25701 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com

Locations
Poland
Recruiting
Bartoszyce, Poland, 11-200
Recruiting
Bydgoszcz, Poland, 85-681
Recruiting
Ciechanow, Poland, 06-400
Recruiting
Czestochowa, Poland, 42-200
Recruiting
Debica, Poland, 39-200
Recruiting
Gliwice, Poland, 44-100
Recruiting
Gorzow Wielkopolski, Poland, 64-400
Completed
Grudziadz, Poland, 86-300
Recruiting
Hajnowka, Poland, 17-200
Recruiting
Jastrzebie Zdrój, Poland, 44-330
Recruiting
Jaworzno, Poland, 43-600
Terminated
Kepno, Poland, 63-600
Completed
Konin, Poland, 62-504
Completed
Koscierzyna, Poland, 83-400
Active, not recruiting
Lapy, Poland, 18-100
Terminated
Lodz, Poland, 90-153
Completed
Milicz, Poland, 56-300
Recruiting
Pila, Poland, 64-920
Recruiting
Polanica Zdroj, Poland, 57-320
Recruiting
Radom, Poland, 26-610
Recruiting
Rybnik, Poland, 44-200
Recruiting
Rzeszow, Poland, 35-301
Terminated
Rzeszow, Poland, 35-055
Recruiting
Sandomierz, Poland, 27-600
Completed
Siedlce, Poland, 08-110
Recruiting
Slupsk, Poland, 76-200
Terminated
Starachowice, Poland, 27-200
Recruiting
Suwalki, Poland, 16-400
Recruiting
Swiecie, Poland, 86-100
Recruiting
Warszawa, Poland, 04-141
Recruiting
Wolomin, Poland, 05-200
Completed
Wroclaw, Poland, 51-124
Recruiting
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: July 7, 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 July 29, 2014