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

June 13, 2017 updated by: Hoffmann-La Roche

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

223

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

  • Germany
      • Mettmann, Germany, 40822
        • Dres. Michael Koch Hannelore Klimke Wolfgang Kulas u.w.

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

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

Description

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

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
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 Names:
  • Mircera

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Month 7 to Month 9

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Month 7 to Month 9
Average Duration in Days Mircera Was Administered at a Stable Dose
Time Frame: Up to 9 months
Up to 9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

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, 2009

Primary Completion (Actual)

February 28, 2011

Study Completion (Actual)

February 28, 2011

Study Registration Dates

First Submitted

November 3, 2015

First Submitted That Met QC Criteria

November 3, 2015

First Posted (Estimate)

November 4, 2015

Study Record Updates

Last Update Posted (Actual)

July 2, 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

  • ML22000

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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