Text Size

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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01309269
First received: March 3, 2011
Last updated: May 7, 2013
Last verified: May 2013
History of Changes
  Purpose

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


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:

MedlinePlus related topics: Anemia
U.S. FDA Resources

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
Estimated Study Completion Date: December 2013
Estimated 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
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: May 7, 2013
Health Authority: Germany: Bundesinstitut für Arzneimittel und Medizinprodukte

Additional relevant MeSH terms:
Anemia
Hematologic Diseases

ClinicalTrials.gov processed this record on May 19, 2013