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

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: NCT01213485
Recruitment Status : Completed
First Posted : October 4, 2010
Last Update Posted : November 2, 2016
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
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.

Condition or disease

Study Type : Observational
Actual Enrollment : 419 participants
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
Study Start Date : March 2010
Actual Primary Completion Date : October 2011
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine


Primary Outcome Measures :
  1. Haemoglobin levels [ Time Frame: Month 6 ]
  2. Mircera therapy (dosage, schedule, mode of application) in the treatment of anemia in clinical practice [ Time Frame: Month 6 ]

Secondary Outcome Measures :
  1. Change in haemoglobin/haematocrit [ Time Frame: from baseline to Month 12 ]
  2. Biological parameters of anemia: transferrin saturation, serum ferritin, folates [ Time Frame: 12 months ]
  3. Efficacy of dialysis (Kt/V, urea levels) [ Time Frame: 12 months ]
  4. Safety: Incidence of adverse events [ Time Frame: 12 months ]
  5. Compliance (treatment modification or discontinuation) [ Time Frame: 12 months ]
  6. Quality of life: Short Form (SF-36) questionnaire [ Time Frame: 12 months ]

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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
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

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): NCT01213485

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

Responsible Party: Hoffmann-La Roche Identifier: NCT01213485     History of Changes
Other Study ID Numbers: ML22643
First Posted: October 4, 2010    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency