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

Completed

• Conditions: Renal Impairment; Renal Anemia of Chronic Kidney Disease
• Interventions: Drug: Methoxy polyethylene glycol epoetin beta

• Registration Number: NCT02596945
• Lead Sponsor: Hoffmann-La Roche

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07-31
• Primary Completion: 2011-02-28
• Study Completion: 2011-02-28
• Study First Submitted: 2015-11-03
• Study First Submitted QC: 2015-11-03
• Study First Posted: 2015-11-04
• Results First Submitted: 2015-12-07
• Results First Submitted QC: 2015-12-07
• Results First Posted: 2016-01-13
• Status Verified: 2017-05
• Last Update Submitted: 2017-06-13
• Last Update Posted: 2017-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 223

Inclusion Criteria

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

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Exclusion Criteria

N/A

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Peritoneal Dialysis participants	Methoxy polyethylene glycol epoetin beta	Participants who are on peritoneal dialysis and have been prescribed with methoxy polyethylene glycol were observed for a period of 9 months.

Primary Outcome Measures

Name	Time	Method
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)	Month 7 to Month 9

Secondary Outcome Measures

Name	Time	Method
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)	Month 7 to Month 9
Average Duration in Days Mircera Was Administered at a Stable Dose	Up to 9 months

Trial Locations

Locations (1)

Dres. Michael Koch Hannelore Klimke Wolfgang Kulas u.w.; 🇩🇪 Mettmann, Germany