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.

Study Overview

• Status: Completed
• Conditions: Anemia

• Study Type: Observational
• Enrollment (Actual): 247

Contacts and Locations

Study 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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with renal anemia and on dialysis therapy

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Cohort

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of patients who achieve a hemoglobin level of >/=10 g/dl	12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Safety: incidence of adverse events	12 months

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: September 19, 2012
• First Submitted That Met QC Criteria: September 19, 2012
• First Posted (Estimate): September 21, 2012

Study Record Updates

• Last Update Posted (Estimate): November 2, 2016
• Last Update Submitted That Met QC Criteria: November 1, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hematologic Diseases; Anemia
• Other Study ID Numbers: ML25701