Observational Study to Investigate the Long-term Effects of MIRCERA in Clinical Routine

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01309269
First received: March 3, 2011
Last updated: August 4, 2014
Last verified: August 2014
  Purpose

This observational study will assess the effect of long-term treatment with Mirc era (methoxy polyethylene glycol-epoetin beta) in chronic kidney disease patient s with renal anemia. Data will be collected from each patient for at least 24 mo nths.


Condition
Anemia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Non-interventional Study to Investigate the Long Term Effects of MIRCERA in Clinical Routine

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Haemoglobin levels in relation to dosage used [ Time Frame: >/= 24 months ] [ Designated as safety issue: No ]

Enrollment: 1083
Study Start Date: September 2010
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Chronic kidney disease patients treated with Mircera for renal anemia

Criteria

Inclusion Criteria:

  • Adult patients, >/= 18 years of age
  • Patients with chronic kidney disease (CKD), stages IV and V
  • Treatment with Mircera according to label

Exclusion Criteria:

  • Pregnant or breastfeeding women
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01309269

Locations
Germany
Lüdenscheid, Germany, 58515
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01309269     History of Changes
Other Study ID Numbers: ML22911
Study First Received: March 3, 2011
Last Updated: August 4, 2014
Health Authority: Germany: Bundesinstitut für Arzneimittel und Medizinprodukte

Additional relevant MeSH terms:
Anemia
Hematologic Diseases

ClinicalTrials.gov processed this record on August 25, 2014