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An Observational Study of Mircera in Patients With Chronic Renal Anemia on Dialysis (CKD Stage V) or Not on Dialysis (CKD Stage III-IV)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01667380
First Posted: August 17, 2012
Last Update Posted: November 2, 2016
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.
Information provided by (Responsible Party):
Hoffmann-La Roche
  Purpose
This observational study will evaluate the use and efficacy of Mircera (methoxy polyethylene glycol-epoetin beta) in anemia patients with chronic kidney disease (CKD) stage III-IV not on dialysis or CKD stage V on dialysis. Patients will be followed during 12 months of treatment.

Condition
Anemia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Non-interventional Study on the Use of Mircera in the Treatment of Chronic Renal Anemia in Patients With Chronic Kidney Disease Stages III-IV Not on Dialysis and in Patients on Stage V on Hemodialysis

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Dosage/schedule of Mircera treatment in clinical practice [ Time Frame: approximately 3 years ]

Secondary Outcome Measures:
  • Proportion of patients with mean Hb level 10-12 g/dL 10 to 12 months after initiation of treatment [ Time Frame: approximately 3 years ]
  • Change in Hb levels [ Time Frame: from baseline to Month 12 ]

Enrollment: 78
Study Start Date: April 2012
Study Completion Date: April 2015
Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Anemia patients with chronic kidney disease (CKD) stage III-IV not on dialysis or CKD stage V on dialysis
Criteria

Inclusion Criteria:

  • Adult patients, >/= 18 years of age
  • Patients with chronic renal anemia with stage III-IV CKD not on dialysis and who are, in the opinion of the treating physician, not expected at baseline to require dialysis within 12 months
  • Patients with chronic renal anemia with stage V CKD on dialysis
  • No contraindication to ESA treatment

Exclusion Criteria:

  • Uncontrolled hypertension
  • Hypersensitivity to the active substance or any other of the excipients of Mircera and other ESAs
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01667380


Locations
Montenegro
Podgorica, Montenegro, 81 000
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01667380     History of Changes
Other Study ID Numbers: ML25617
First Submitted: August 13, 2012
First Posted: August 17, 2012
Last Update Posted: November 2, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
Anemia
Hematologic Diseases