An Observational Study of Mircera (Methoxy Polyethylene Glycol-Epoetin Beta) in Patients With Chronic Kidney Disease in Pre-Dialysis or Dialysis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01309295
First received: March 3, 2011
Last updated: July 7, 2014
Last verified: July 2014
  Purpose

This prospective observational study will assess the efficacy and safety of Mirc era (methoxy polyethylene glycol-epoetin beta) in clinical practice in patients with chronic kidney disease, in pre-dialysis or on dialysis, initiated on Mircer a treatment. Data from each patient will be collected over 12 months of treatmen t.


Condition
Anemia, Kidney Disease, Chronic

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Study Evaluating the Efficacy and Safety of Mircera in Patients With CKD in Predialysis and Dialysis.

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Achievement of target hemoglobin (Hb) range of 10-12 g/dL according to Kidney Disease Outcomes Quality Initiative (KDQOI) guidelines [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Maintenance of target Hb range (10-12 g/dL) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Correlation between baseline clinical variables and time on target Hb level [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Dosing pattern in clinical practice, including dose adaptations [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Frequency of visits and laboratory assessments [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Effect of compliance to treatment on Hb levels [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 250
Study Start Date: November 2010
Study Completion Date: November 2012
Primary Completion Date: November 2012 (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 initiated on Mircera treatment

Criteria

Inclusion Criteria:

  • Adult patients, >/= 18 years of age
  • Chronic kidney disease, in pre-dialysis or dialysis
  • Appropriate for treatment with Mircera according to current guidelines and Summary of Product Characteristics

Exclusion Criteria:

  • Anemia due to non-renal causes
  • Pregnant or lactating women
  • Uncontrolled hypertension
  • Known hypersensitivity to methoxy polyethylene glycol-epoetin beta
  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: NCT01309295

Locations
Albania
Tirane, Albania, 1000
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: NCT01309295     History of Changes
Other Study ID Numbers: ML25465
Study First Received: March 3, 2011
Last Updated: July 7, 2014
Health Authority: Albania: National Center Drug Control

Additional relevant MeSH terms:
Anemia
Chronic Disease
Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Hematologic Diseases
Disease Attributes
Pathologic Processes
Urologic Diseases
Renal Insufficiency

ClinicalTrials.gov processed this record on July 24, 2014