An Observational Study of Mircera (Methoxy Polyethylene Glycol-Epoetin Beta) in Stage V Chronic Kidney Disease Patients on Haemodialysis

Anemia Clinical Trial

Official title:

An Observational, Non-interventional Cohort Study to Observe the Efficacy and Use of MIRCERA in the Treatment of Chronic Renal Anaemia in Patients With Chronic Kidney Disease Stage V on Haemodialysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01940484
• Other study ID #: ML22344
• Status: Completed
• Phase: N/A
• First received: September 9, 2013
• Last updated: October 1, 2015
• Start date: July 2009
• Est. completion date: July 2010

Study information

• Verified date: October 2015
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Africa: Medicines Control Council
• Study type: Observational

Clinical Trial Summary

This observational study will evaluate the efficacy and use of Mircera (methoxy polyethylene glycol-epoetin beta) in patients with Stage V chronic kidney disease on haemodialysis receiving an erythropoietin prior to study entry. Attending physicians should have made the decision of placing the patient on Mircera in advance and not related to the study. The therapy will be administered by the attendant treating physician according to specifications in the package insert guidelines and to the routine of the site. Eligible patients will be followed for 6 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients, >/= 18 years of age

• Patients with chronic renal anemia with Stage V chronic kidney disease on dialysis and with a Hb level of 10.0 - 13.0 g/dl

• Patients must be receiving an ESA prior to entering study

Exclusion Criteria:

• As per approved package insert

• Any contraindication to ESA treatment

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Anemia
• 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

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients with Hb levels of 11-12 g/dl during the entire study period and at 4-6 months		6 months	No
Primary	Change in Hb levels		from baseline to Month 6	No
Secondary	Mean Mircera dose during study and at Month 6		6 months	No
Secondary	Dose adjustments/interruptions		6 months	No
Secondary	Proportion of patients managed according to the EBPG and K/DOQI guidelines and Mircera PI prior to and during Mircera treatment		9 months	No
Secondary	Clinical/demographic patient characteristics at initiation of treatment		6 months	No