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

Completed

• Conditions: Kidney Disease, Chronic

• Registration Number: NCT01318512
• Lead Sponsor: Hoffmann-La Roche

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07-31
• Study First Submitted: 2011-03-17
• Study First Submitted QC: 2011-03-17
• Study First Posted: 2011-03-18
• Primary Completion: 2013-12-31
• Study Completion: 2013-12-31
• Results First Submitted: 2015-10-29
• Results First Submitted QC: 2015-10-29
• Results First Posted: 2015-12-03
• Status Verified: 2017-05
• Last Update Submitted: 2017-06-13
• Last Update Posted: 2017-07-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 340

Inclusion Criteria

• Adults patients, >/=18 years of age
• Presence of chronic kidney disease (Stage 3-4)

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Exclusion Criteria

• Participation in another clinical study

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Average Dose of MIRCERA at Entry Level	Baseline	The average dose of MIRCERA, measured in micrograms (µg) at entry level was reported.
Average Dose of MIRCERA During Titration Period Month 1	Month 1	The average dose of MIRCERA, measured in microgram (µg) at each month interval during the titration period was reported.
Average Dose of MIRCERA During Titration Period Month 2	Month 2	The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the titration period was reported.
Average Dose of MIRCERA During Titration Period Month 3	Month 3	The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the titration period was reported.
Average Dose of MIRCERA During Titration Period Month 4	Month 4	The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the titration period was reported.
Average Dose of MIRCERA During Maintenance Period Month 1	Month 5 (Maintenance Period Month 1)	The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the maintenance period was reported.
Average Dose of MIRCERA During Maintenance Period Month 2	Month 6 (Maintenance Period Month 2)	The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the maintenance period was reported.
Average Dose of MIRCERA During Maintenance Period Month 3	Month 7 (Maintenance Period Month 3)	The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the maintenance period was reported.
Average Dose of MIRCERA During Maintenance Period Month 4	Month 8 (Maintenance Period Month 4)	The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the maintenance period was reported.
Average Dose of MIRCERA During Maintenance Period Month 5	Month 9 (Maintenance Period Month 5)	The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the maintenance period was reported.
Average Dose of MIRCERA During Maintenance Period Month 6	Month 10 (Maintenance Period Month 6)	The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the maintenance period was reported.

Secondary Outcome Measures

Name	Time	Method
The Mean Hemoglobin (Hb) Level During Titration Period	Baseline, Month 1, 2, 3, 4	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.
The Mean Hemoglobin (Hb) Level During Maintenance Period	Month 5, 6, 7, 8, 9, 10	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

Trial Locations

Locations (1)

Nemocnice Novy Jicin; Dialyzacni Stredisko; 🇨🇿 Novy Jicin, Czechia