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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.
Information provided by (Responsible Party):
Hoffmann-La Roche Identifier:
First received: August 13, 2012
Last updated: November 1, 2016
Last verified: November 2016
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.


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)


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

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
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Please refer to this study by its identifier: NCT01667380

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

Responsible Party: Hoffmann-La Roche Identifier: NCT01667380     History of Changes
Other Study ID Numbers: ML25617
Study First Received: August 13, 2012
Last Updated: November 1, 2016

Additional relevant MeSH terms:
Hematologic Diseases processed this record on May 25, 2017