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

This study has been completed.
Information provided by (Responsible Party):
Hoffmann-La Roche Identifier:
First received: September 28, 2010
Last updated: May 4, 2016
Last verified: May 2016
This observational study will evaluate the course of treatment, the efficacy on anemia and the safety of Mircera (methoxy polyethylene glycol-epoetin beta) in patients with chronic kidney disease on dialysis. Eligible patients will be on either haemodialysis or peritoneal dialysis and treatment-naïve for or having had prior therapy with erythropoiesis stimulating agents (ESA). Data will be collected from each patient for 12 months.


Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observational Cohort Study in Chronic Kidney Disease Patients on Dialysis Initiating Treatment With Mircera During the Correction and Maintenance Phase

Resource links provided by NLM:

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Haemoglobin levels [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
  • Mircera therapy (dosage, schedule, mode of application) in the treatment of anemia in clinical practice [ Time Frame: Month 6 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in haemoglobin/haematocrit [ Time Frame: from baseline to Month 12 ] [ Designated as safety issue: No ]
  • Biological parameters of anemia: transferrin saturation, serum ferritin, folates [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Efficacy of dialysis (Kt/V, urea levels) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Compliance (treatment modification or discontinuation) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Quality of life: Short Form (SF-36) questionnaire [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 419
Study Start Date: March 2010
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with chronic kidney disease on dialysis

Inclusion Criteria:

  • Adult patients, >/= 18 years of age
  • Chronic kidney disease, on dialysis for > 3 months
  • Treatment-naïve or previous treatment with ESA
  • Initiation of treatment with Mircera for renal insufficiency associated anemia by decision of the treating physician

Exclusion Criteria:

  • Participation in a clinical trial
  • Anemia due to an associated malignant pathology
  Contacts and Locations
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Please refer to this study by its identifier: NCT01213485

Neuilly-sur-seine, France, 92521
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche Identifier: NCT01213485     History of Changes
Other Study ID Numbers: ML22643 
Study First Received: September 28, 2010
Last Updated: May 4, 2016
Health Authority: France: Commission nationale de l'informatique et des libértes (CNIL)

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Urologic Diseases processed this record on May 22, 2016