Clinical Trial Protocol Registry

Trial information

A Retrospective Observational Study of Hemoglobin Levels in Patients With Renal Anemia Treated With Mircera (Methoxy Polyethylene Glycol-Epoetin Beta)

Status:
Completed
Protocol number:
ML22014
Sponsor:
Hoffmann-La Roche
Company division:
Pharmaceutical
Official Scientific Title:
Non-interventional study of six-month retrospective reporting of hemoglobin levels in patients with renal anaemia who are treated with MIRCERA® (methoxy-polyethylene-glycol-epoetin beta)
Brief summary:
This retrospective observational study will evaluate the hemoglobin levels in patients with renal anemia over 6 months treatment with Mircera (methoxy polyethylene glycol-epoetin beta). Target sample size is 780.
Study phase:
IV
Study type:
Observational study
Conditions:
  • Anemia
  • Kidney Disease, Chronic
Primary outcome:
  1. Percentage of patients achieving a 3-months hemoglobin level stabilization within the range of 11-12 g/dL Time frame: 6 months
Key secondary outcomes:
  1. Percentage of patients achieving a 6-months hemoglobin level stabilization within the range of 11-12 g/dL Time frame: 6 months
Inclusion criteria:
  • Adult patients, >/= 18 years of age
  • Renal anemia treated with Mircera for at least 6 months before entering study
Exclusion criteria:
  • Patients who refuse or are incapable of giving their written informed consent to retrospective data collection
Gender:
Males or Females
Age limits:
Min: 18 years Max: N/A (No limit)
Accepts healthy volunteers:
No
Anticipated start date:
April, 2009
Trial registration date:
10.06.2011
Date last updated:
04.06.2013
This trial was conducted at the following locations:
Greece
  • ATHENS
  • EGALEO
  • PATRA
  • VOLOS
GREECE
  • Arta
  • Athens
  • DAPHNI-ATHENS
  • Patra
  • Pireus
  • Polygyros
  • Thessaloniki
  • Volos

Link to trial result

For more information on a specific Roche trials in your country location, please contact your local Roche affiliate nearest you.

  • Go on the URL link- http://www.roche.com and click on the Roche Worldwide tab on the top of the page to locate the country nearest you for contact information.

Treatment decisions and/or suitability for a specific trial are decisions only your healthcare provider can make. If you are patient interested in any of the global studies, please have your healthcare provider contact us and they will be provided with the relevant clinical trial information.

For US or global trials with US sites only, please contact the Trial Information Support Line (TISL)