Skip to main content
OpenTrials
Completed

NCT Number: NCT02596945

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Renal Impairment Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Anemia of Chronic Kidney Disease Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Dres. Michael Koch Hannelore Klimke Wolfgang Kulas u.w.

Mettmann, 40822, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Methoxy polyethylene glycol epoetin beta

Drug

Methoxy polyethylene glycol epoetin beta is prescribed as per physician's discretion in accordance with the Summary of Product Characteristics (SmPC).

Other names: Mircera

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Nov 4, 2015
Registry last updated
Jul 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.