An Observational Study of Mircera (Methoxy Polyethylene Glycol-Epoetin Beta) in Patients With Chronic Kidney Disease in Pre-Dialysis or Dialysis

Anemia, Kidney Disease, Chronic Clinical Trial

Official title:

A Prospective Study Evaluating the Efficacy and Safety of Mircera in Patients With CKD in Predialysis and Dialysis.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01309295
• Other study ID #: ML25465
• Status: Completed
• Phase: N/A
• First received: March 3, 2011
• Last updated: November 1, 2016
• Start date: November 2010
• Est. completion date: November 2012

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Albania: National Center Drug Control
• Study type: Observational

Clinical Trial Summary

This prospective observational study will assess the efficacy and safety of Mircera (methoxy polyethylene glycol-epoetin beta) in clinical practice in patients with chronic kidney disease, in pre-dialysis or on dialysis, initiated on Mircera treatment. Data from each patient will be collected over 12 months of treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients, >/= 18 years of age

• Chronic kidney disease, in pre-dialysis or dialysis

• Appropriate for treatment with Mircera according to current guidelines and Summary of Product Characteristics

Exclusion Criteria:

• Anemia due to non-renal causes

• Pregnant or lactating women

• Uncontrolled hypertension

• Known hypersensitivity to methoxy polyethylene glycol-epoetin beta

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• 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

Albania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Achievement of target hemoglobin (Hb) range of 10-12 g/dL according to Kidney Disease Outcomes Quality Initiative (KDQOI) guidelines		2 years	No
Primary	Maintenance of target Hb range (10-12 g/dL)		2 years	No
Primary	Safety: Incidence of adverse events		2 years	No
Secondary	Correlation between baseline clinical variables and time on target Hb level		2 years	No
Secondary	Dosing pattern in clinical practice, including dose adaptations		2 years	No
Secondary	Frequency of visits and laboratory assessments		2 years	No
Secondary	Effect of compliance to treatment on Hb levels		2 years	No