An Observational Study of Mircera (Methoxy Polyethylene Glycol-epoetin Beta) in Patients With Chronic Kidney Disease Not On Dialysis

Kidney Disease, Chronic Clinical Trial

Official title:

The Dosage of MIRCERA in the Treatment of Renal Anaemia in Patients With Chronic Renal Disease Who do Not Undergo Haemodialysis in Clinical Practice

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01318512
• Other study ID #: ML25317
• Status: Completed
• Phase: N/A
• First received: March 17, 2011
• Last updated: January 14, 2016
• Start date: July 2010
• Est. completion date: December 2013

Study information

• Verified date: January 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Czech Republic: State Institute for Drug Control
• Study type: Observational

Clinical Trial Summary

This observational, prospective, multicenter study will describe the mean dose of Mircera (methoxy polyethylene glycol-epoetin beta) and the hemoglobin levels in patients with chronic kidney disease. Patients are not on dialysis and are naive to, or have received erythropoiesis stimulating agent treatment. Data will be collected for 10 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 340
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adults patients, >/=18 years of age

• Presence of chronic kidney disease (Stage 3-4)

Exclusion Criteria:

• Participation in another clinical study

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Disease
• Kidney Disease, Chronic
• 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

Czech Republic, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average Dose of MIRCERA at Entry Level	The average dose of MIRCERA, measured in micrograms (µg) at entry level was reported.	Baseline	No
Primary	Average Dose of MIRCERA During Titration Period Month 1	The average dose of MIRCERA, measured in microgram (µg) at each month interval during the titration period was reported.	Month 1	No
Primary	Average Dose of MIRCERA During Titration Period Month 2	The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the titration period was reported.	Month 2	No
Primary	Average Dose of MIRCERA During Titration Period Month 3	The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the titration period was reported.	Month 3	No
Primary	Average Dose of MIRCERA During Titration Period Month 4	The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the titration period was reported.	Month 4	No
Primary	Average Dose of MIRCERA During Maintenance Period Month 1	The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the maintenance period was reported.	Month 5 (Maintenance Period Month 1)	No
Primary	Average Dose of MIRCERA During Maintenance Period Month 2	The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the maintenance period was reported.	Month 6 (Maintenance Period Month 2)	No
Primary	Average Dose of MIRCERA During Maintenance Period Month 3	The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the maintenance period was reported.	Month 7 (Maintenance Period Month 3)	No
Primary	Average Dose of MIRCERA During Maintenance Period Month 4	The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the maintenance period was reported.	Month 8 (Maintenance Period Month 4)	No
Primary	Average Dose of MIRCERA During Maintenance Period Month 5	The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the maintenance period was reported.	Month 9 (Maintenance Period Month 5)	No
Primary	Average Dose of MIRCERA During Maintenance Period Month 6	The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the maintenance period was reported.	Month 10 (Maintenance Period Month 6)	No
Secondary	The Mean Hemoglobin (Hb) Level During Titration Period	The hemoglobin level was measured in grams per liter (g/L) at entry level and after each month of treatment with MIRCERA. The study did not distinguish between erythropoiesis stimulating agent naive and erythropoiesis stimulating agent treated participants, and collected the overall data (Hb level) before/after administration of MIRCERA.	Baseline, Month 1, 2, 3, 4	No
Secondary	The Mean Hemoglobin (Hb) Level During Maintenance Period	The hemoglobin level was measured in grams per liter (g/L) after each month of treatment with MIRCERA. The study did not distinguish between erythropoiesis stimulating agent naive and erythropoiesis stimulating agent treated participants, and collected the overall data (Hb level) before/after administration of MIRCERA	Month 5, 6, 7, 8, 9, 10	No