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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01309295
Recruitment Status : Completed
First Posted : March 7, 2011
Last Update Posted : November 2, 2016
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
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 or disease
Anemia, Kidney Disease, Chronic

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Study Type : Observational
Actual Enrollment : 250 participants
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.
Study Start Date : November 2010
Actual Primary Completion Date : November 2012
Actual Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases


Primary Outcome Measures :
  1. Achievement of target hemoglobin (Hb) range of 10-12 g/dL according to Kidney Disease Outcomes Quality Initiative (KDQOI) guidelines [ Time Frame: 2 years ]
  2. Maintenance of target Hb range (10-12 g/dL) [ Time Frame: 2 years ]
  3. Safety: Incidence of adverse events [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Correlation between baseline clinical variables and time on target Hb level [ Time Frame: 2 years ]
  2. Dosing pattern in clinical practice, including dose adaptations [ Time Frame: 2 years ]
  3. Frequency of visits and laboratory assessments [ Time Frame: 2 years ]
  4. Effect of compliance to treatment on Hb levels [ Time Frame: 2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Chronic kidney disease patients initiated on Mircera treatment

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01309295

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Tirane, Albania, 1000
Sponsors and Collaborators
Hoffmann-La Roche
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Study Director: Clinical Trials Hoffmann-La Roche

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Responsible Party: Hoffmann-La Roche Identifier: NCT01309295     History of Changes
Other Study ID Numbers: ML25465
First Posted: March 7, 2011    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency