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: April 2, 2016
Last verified: April 2016
  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

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Hemoglobin Levels at Monthly Intervals [ Time Frame: Prior to Day 1, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 ] [ Designated as safety issue: No ]
    Hemoglobin levels were measured as grams/deciliter (g/dL).

  • Percentage of Participants Within Pre-defined Range of Hemoglobin Values [ Time Frame: Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 ] [ Designated as safety issue: No ]
    Percentage of participants with hemoglobin values within the following pre-defined ranges is presented: 11-12 gram/deciliter (g/dL), 10-12 g/dL, 11-13 g/dL, and 10-13 g/dL.

  • Average Methoxy Polyethylene Glycol-epoetin Beta Dose [ Time Frame: Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 ] [ Designated as safety issue: No ]
    Average methoxy polyethylene glycol-epoetin beta dose per application by study month. Mean values were taken when more than 1 application was documented for a participant during the time period considered.


Enrollment: 1083
Study Start Date: September 2010
Study Completion Date: April 2014
Primary Completion Date: April 2014 (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

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01309269     History of Changes
Other Study ID Numbers: ML22911 
Study First Received: March 3, 2011
Results First Received: September 2, 2015
Last Updated: April 2, 2016
Health Authority: Germany: Bundesinstitut für Arzneimittel und Medizinprodukte

ClinicalTrials.gov processed this record on May 03, 2016