- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01318512
An Observational Study of Mircera (Methoxy Polyethylene Glycol-epoetin Beta) in Patients With Chronic Kidney Disease Not On Dialysis
June 13, 2017 updated by: Hoffmann-La Roche
The Dosage of MIRCERA in the Treatment of Renal Anaemia in Patients With Chronic Renal Disease Who do Not Undergo Haemodialysis in Clinical Practice
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
340
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Novy Jicin, Czechia, 741 11
- Nemocnice Novy Jicin; Dialyzacni Stredisko
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Patients with chronic kidney disease receiving Mircera treatment
Description
Inclusion Criteria:
- Adults patients, >/=18 years of age
- Presence of chronic kidney disease (Stage 3-4)
Exclusion Criteria:
- Participation in another clinical study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Chronic Kidney Disease
Participants with CKD, not undergoing haemodialysis in clinical practice setting and started treatment with methoxy polyethylene glycol-epoetin beta (MIRCERA) subcutaneously (SC) as per summary of product characteristics (SPC) due to decreased levels of haemoglobin.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Average Dose of MIRCERA at Entry Level
Time Frame: Baseline
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The average dose of MIRCERA, measured in micrograms (µg) at entry level was reported.
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Baseline
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Average Dose of MIRCERA During Titration Period Month 1
Time Frame: Month 1
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The average dose of MIRCERA, measured in microgram (µg) at each month interval during the titration period was reported.
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Month 1
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Average Dose of MIRCERA During Titration Period Month 2
Time Frame: Month 2
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The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the titration period was reported.
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Month 2
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Average Dose of MIRCERA During Titration Period Month 3
Time Frame: Month 3
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The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the titration period was reported.
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Month 3
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Average Dose of MIRCERA During Titration Period Month 4
Time Frame: Month 4
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The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the titration period was reported.
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Month 4
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Average Dose of MIRCERA During Maintenance Period Month 1
Time Frame: Month 5 (Maintenance Period Month 1)
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The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the maintenance period was reported.
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Month 5 (Maintenance Period Month 1)
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Average Dose of MIRCERA During Maintenance Period Month 2
Time Frame: Month 6 (Maintenance Period Month 2)
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The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the maintenance period was reported.
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Month 6 (Maintenance Period Month 2)
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Average Dose of MIRCERA During Maintenance Period Month 3
Time Frame: Month 7 (Maintenance Period Month 3)
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The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the maintenance period was reported.
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Month 7 (Maintenance Period Month 3)
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Average Dose of MIRCERA During Maintenance Period Month 4
Time Frame: Month 8 (Maintenance Period Month 4)
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The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the maintenance period was reported.
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Month 8 (Maintenance Period Month 4)
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Average Dose of MIRCERA During Maintenance Period Month 5
Time Frame: Month 9 (Maintenance Period Month 5)
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The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the maintenance period was reported.
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Month 9 (Maintenance Period Month 5)
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Average Dose of MIRCERA During Maintenance Period Month 6
Time Frame: Month 10 (Maintenance Period Month 6)
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The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the maintenance period was reported.
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Month 10 (Maintenance Period Month 6)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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The Mean Hemoglobin (Hb) Level During Titration Period
Time Frame: Baseline, Month 1, 2, 3, 4
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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.
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Baseline, Month 1, 2, 3, 4
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The Mean Hemoglobin (Hb) Level During Maintenance Period
Time Frame: Month 5, 6, 7, 8, 9, 10
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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
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Month 5, 6, 7, 8, 9, 10
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 31, 2010
Primary Completion (Actual)
December 31, 2013
Study Completion (Actual)
December 31, 2013
Study Registration Dates
First Submitted
March 17, 2011
First Submitted That Met QC Criteria
March 17, 2011
First Posted (Estimate)
March 18, 2011
Study Record Updates
Last Update Posted (Actual)
July 5, 2017
Last Update Submitted That Met QC Criteria
June 13, 2017
Last Verified
May 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ML25317
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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