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NCT Number: NCT01213485

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

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.

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Key information

Conditions

Anemia Hematologic Diseases Hemic and Lymphatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Neuilly-sur-Seine, 92521, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

Observational Cohort Study in Chronic Kidney Disease Patients on Dialysis Initiating Treatment With Mircera During the Correction and Maintenance Phase

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Oct 4, 2010
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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