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NCT02596945 Clinical Trial

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

Renal Impairment Clinical Trial

Official title:
Non-Interventional Observation Trial to Investigate the Efficacy, Safety and Usability of Mircera in PD Patients in Daily Use

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02596945
Other study ID # ML22000
Secondary ID
Status Completed
Phase N/A
First received November 3, 2015
Last updated December 7, 2015
Start date July 2009
Est. completion date February 2011

Study information
Verified date December 2015
Source Hoffmann-La Roche
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute of Drugs and Medical Devices
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 223
Est. completion date February 2011
Est. primary completion date February 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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:

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

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).

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 No
Secondary 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 No
Secondary Average Duration in Days Mircera Was Administered at a Stable Dose Up to 9 months No
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