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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01309295
First received: March 3, 2011
Last updated: May 7, 2013
Last verified: May 2013
History of Changes
  Purpose

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


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:

U.S. FDA Resources

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
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 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 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
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: May 7, 2013
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 May 22, 2013