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

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

September 28, 2010
October 4, 2010
November 2, 2016
March 2010
October 2011   (Final data collection date for primary outcome measure)
  • Haemoglobin levels [ Time Frame: Month 6 ]
  • Mircera therapy (dosage, schedule, mode of application) in the treatment of anemia in clinical practice [ Time Frame: Month 6 ]
Same as current
Complete list of historical versions of study NCT01213485 on ClinicalTrials.gov Archive Site
  • Change in haemoglobin/haematocrit [ Time Frame: from baseline to Month 12 ]
  • Biological parameters of anemia: transferrin saturation, serum ferritin, folates [ Time Frame: 12 months ]
  • Efficacy of dialysis (Kt/V, urea levels) [ Time Frame: 12 months ]
  • Safety: Incidence of adverse events [ Time Frame: 12 months ]
  • Compliance (treatment modification or discontinuation) [ Time Frame: 12 months ]
  • Quality of life: Short Form (SF-36) questionnaire [ Time Frame: 12 months ]
Same as current
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An Observational Study of Mircera (Methoxy Polyethylene Glycol-Epoetin Beta) in Patients With Chronic Kidney Disease on Dialysis (HORTENSIA)
Observational Cohort Study in Chronic Kidney Disease Patients on Dialysis Initiating Treatment With Mircera During the Correction and Maintenance Phase
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.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample
Patients with chronic kidney disease on dialysis
Anemia
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Cohort
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
419
400
October 2011
October 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT01213485
ML22643
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Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
November 2016