An Observational Study of Mircera (Methoxy Polyethylene Glycol-Epoetin Beta) as Maintenance Treatment in Patients With Chronic Renal Anemia on Haemodialysis

Anemia, Kidney Disease, Chronic Clinical Trial

Official title:

An Observational. Non-interventional Study to Observe the Safety and Efficacy of MIRCERA in the Treatment of Chronic Renal Anemia in Maintenance ESA Treated Patients on Haemodialysis (STABILE)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01422824
• Other study ID #: ML25067
• Status: Completed
• Phase: N/A
• First received: August 23, 2011
• Last updated: November 2, 2015
• Start date: June 2010
• Est. completion date: January 2014

Study information

• Verified date: November 2015
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Macedonia: Ministry of Health
• Study type: Observational

Clinical Trial Summary

This prospective observational study will evaluate the safety and efficacy of Mircera (methoxy polyethylene glycol-epoetin beta) in patients with chronic renal anemia on haemodialysis in maintenance ESA treatment. Data will be collected from patients receiving once monthly Mircera according to standard of care and local labelling during 12 months of treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 185
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients, >/= 18 years of age

• Stage IV chronic kidney disease, on haemodialysis

• Chronic renal anemia, on maintenance ESA treatment

• Hemoglobin concentration between 10.0 an 12 g/dL

• Continuous maintenance epoetin therapy with the same dosing interval during the previous month

Exclusion Criteria:

• Contraindications to ESA treatment (e.g. hypersensitivity, non-controlled hypertension)

• Hemoglobinopathies (e.g. homozygous sickle-cell disease, thalassemia of all types)

• Anemia due to hemolysis, pure red cell aplasia

Study Design

Observational Model: Cohort, Time Perspective: Prospective

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

Macedonia, The Former Yugoslav Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety: Incidence of adverse events		approximately 2.5 years	No
Secondary	Long-term maintenance of hemoglobin levels		12 months	No