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Observational Study of Methoxy Polyethylene Glycol Epoetin Beta Daily Use in Participants on Peritoneal Dialysis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02596945
Recruitment Status : Completed
First Posted : November 4, 2015
Results First Posted : January 13, 2016
Last Update Posted : July 2, 2017
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Description
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Brief Summary:
This non-interventional, observational study investigates the efficacy, safety and usability of methoxy polyethylene glycol epoetin beta in participants on peritoneal dialysis. Participants who were prescribed methoxy polyethylene glycol epoetin beta by their doctor and who meet the selection criteria were to be enrolled and documented in this study for a period of 9 months of treatment with methoxy polyethylene glycol epoetin beta with respect to efficacy, safety and usability.

Condition or disease Intervention/treatment
Renal Impairment Renal Anemia of Chronic Kidney Disease Drug: Methoxy polyethylene glycol epoetin beta

Study Design
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Study Type : Observational
Actual Enrollment : 223 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Non-Interventional Observation Trial to Investigate the Efficacy, Safety and Usability of Mircera in PD Patients in Daily Use
Actual Study Start Date : July 31, 2009
Actual Primary Completion Date : February 28, 2011
Actual Study Completion Date : February 28, 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

Groups and Cohorts
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Group/Cohort Intervention/treatment
Peritoneal Dialysis participants
Participants who are on peritoneal dialysis and have been prescribed with methoxy polyethylene glycol were observed for a period of 9 months.
 Drug: Methoxy polyethylene glycol epoetin beta
Methoxy polyethylene glycol epoetin beta is prescribed as per physician's discretion in accordance with the Summary of Product Characteristics (SmPC).
Other Name: Mircera


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants With Hemoglobin Values in the Range of 11-12 Grams Per Deciliter (g/dL) During the Evaluation Period of Visit 7 (Month 7) to Visit 9 (Month 9) [ Time Frame: Month 7 to Month 9 ]

Secondary Outcome Measures :
  1. Percentage of Participants With Hemoglobin Values in the Range of 11-13 g/dL During the Evaluation Period of Visit 7 (Month 7) to Visit 9 (Month 9) [ Time Frame: Month 7 to Month 9 ]
  2. Average Duration in Days Mircera Was Administered at a Stable Dose [ Time Frame: Up to 9 months ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants on peritoneal dialysis who are in need of ESA therapy and have been prescribed methoxy polyethylene glycol beta by the doctor
Criteria

Inclusion Criteria:

  • Participants on peritoneal dialysis
  • Need for Erythropoiesis Stimulating Agent (ESA) therapy
  • Prescription of methoxy polyethylene glycol epoetin beta by the doctor

Exclusion Criteria:

N/A

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02596945


Locations
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Germany
Dres. Michael Koch Hannelore Klimke Wolfgang Kulas u.w.
Mettmann, Germany, 40822
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
More Information
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02596945    
Other Study ID Numbers: ML22000
First Posted: November 4, 2015    Key Record Dates
Results First Posted: January 13, 2016
Last Update Posted: July 2, 2017
Last Verified: May 2017
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
 Urologic Diseases
Epoetin Alfa
Hematinics