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

Anemia Clinical Trial

Official title:

Non-interventional Study to Assess the Efficacy of Mircera for Renal Anemia Correction in Dialysis Patients in Everyday Clinical Practice in Poland.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01690455
• Other study ID #: ML25701
• Status: Completed
• Phase: N/A
• First received: September 19, 2012
• Last updated: November 1, 2016
• Start date: July 2011
• Est. completion date: June 2015

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Pharmacovigilance Department of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 247
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Anemia

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients who achieve a hemoglobin level of >/=10 g/dl		12 months	No
Secondary	Safety: incidence of adverse events		12 months	No