A Retrospective Observational Study of Hemoglobin Levels in Patients With Renal Anemia Treated With Mircera (Methoxy Polyethylene Glycol-Epoetin Beta)

Anemia, Kidney Disease, Chronic Clinical Trial

Official title:

Non-interventional Study of Six-month Retrospective Reporting of Hemoglobin Levels in Patients With Renal Anaemia Who Are Treated With MIRCERA® (Methoxy-polyethylene-glycol-epoetin Beta)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01379963
• Other study ID #: ML22014
• Status: Completed
• Phase: N/A
• First received: June 22, 2011
• Last updated: November 20, 2015
• Start date: April 2009
• Est. completion date: February 2011

Study information

• Verified date: November 2015
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: National Organization for Medicines
• Study type: Observational

Clinical Trial Summary

This retrospective observational study will evaluate the hemoglobin levels in patients with renal anemia over 6 months treatment with Mircera (methoxy polyethylene glycol-epoetin beta).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 780
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients, >/= 18 years of age

• Renal anemia treated with Mircera for at least 6 months before entering study

Exclusion Criteria:

• Patients who refuse or are incapable of giving their written informed consent to retrospective data collection

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Anemia
• Anemia, Kidney Disease, Chronic
• Chronic Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Who Achieved a 3-month Hemoglobin Level Stabilization in the Range of 11-12 Grams Per Deciliter (g/dL)	Hemoglobin level stabilization within the range of 11-12 g/dL was measured on a monthly basis according to Kidney Disease Outcomes Quality Initiative (KDOQI) guidelines, for enrolled participants who had received methoxy-polyethylene-glycol-epoetin beta treatment.	Up to 6 months	No
Secondary	Percentage of Participants Who Achieved a 6-month Hemoglobin Level Stabilization in the Range of 11-12 g/dL	Hemoglobin level Level stabilization within the range of 11-12 g/dL was measured on a monthly basis according to KDOQI guidelines, for enrolled participants who had received methoxy-polyethylene-glycol-epoetin beta treatment.	Up to 6 months	No