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NCT Number: NCT01974271

An Observational Study of Hemoglobin Stability in Chronic Kidney Disease Patients on Dialysis Treated With Mircera (Methoxy Polyethylene Glycol-epoetin Beta)

This prospective, multicenter, observational study will evaluate the impact of comorbidities on hemoglobin stability in chronic kidney disease patients on dialysis treated with Mircera (methoxy polyethylene glycol-epoetin beta). Eligible patients will be followed for 6 months of treatment.

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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

Aix-en-Provence, France

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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 patients on hemodialysis or hemodiafiltration for at least 3 months
  • Previously treated with an erythropoietin stimulating agent (ESA)
  • Patient for whom the investigator decided to initiate treatment with Mircera for medical reasons
  • Last hemoglobin level before initiation of Mircera within the range of 10-12 g/dL

Exclusion criteria

  • Current participation in a clinical trial on renal anemia

Treatment and study plan

Primary outcomes

  1. Percentage of patients with a variation of Hb level of +/- 1 g/dL between the first Mircera injection and Month 6

    Time frame: 6 months

Secondary outcomes

  1. Percentage of patients with Hb value within the range of 10 - 12 g/dL

    Time frame: 6 months

  2. Change in Hb level

    Time frame: from baseline to Month 6

  3. Monthly dose of Mircera

    Time frame: 6 months

  4. Safety: Incidence of adverse events

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

IMPACT OF COMORBITIES ON HEMOGLOBIN STABILITY IN CHONIC KIDNEY DISEASE PATIENTS ON DIALYSIS TREATED WITH C.E.R.A

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Nov 1, 2013
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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