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Completed

NCT Number: NCT01309295

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

This prospective observational study will assess the efficacy and safety of Mircera (methoxy polyethylene glycol-epoetin beta) in clinical practice in patients with chronic kidney disease, in pre-dialysis or on dialysis, initiated on Mircera treatment. Data from each patient will be collected over 12 months of treatment.

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Key information

Conditions

Anemia, Kidney Disease, Chronic Anemia Bronchial Diseases Bronchiolitis Bronchiolitis Obliterans Bronchiolitis Obliterans Syndrome Bronchitis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Graft vs Host Disease Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Kidney Diseases Lung Diseases Lung Diseases, Obstructive Male Urogenital Diseases Organizing Pneumonia Respiratory Tract Diseases Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Tirana, 1000, Albania

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, in pre-dialysis or dialysis
  • Appropriate for treatment with Mircera according to current guidelines and Summary of Product Characteristics

Exclusion criteria

  • Anemia due to non-renal causes
  • Pregnant or lactating women
  • Uncontrolled hypertension
  • Known hypersensitivity to methoxy polyethylene glycol-epoetin beta

Treatment and study plan

Primary outcomes

  1. Achievement of target hemoglobin (Hb) range of 10-12 g/dL according to Kidney Disease Outcomes Quality Initiative (KDQOI) guidelines

    Time frame: 2 years

  2. Maintenance of target Hb range (10-12 g/dL)

    Time frame: 2 years

  3. Safety: Incidence of adverse events

    Time frame: 2 years

Secondary outcomes

  1. Correlation between baseline clinical variables and time on target Hb level

    Time frame: 2 years

  2. Dosing pattern in clinical practice, including dose adaptations

    Time frame: 2 years

  3. Frequency of visits and laboratory assessments

    Time frame: 2 years

  4. Effect of compliance to treatment on Hb levels

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

A Prospective Study Evaluating the Efficacy and Safety of Mircera in Patients With CKD in Predialysis and Dialysis.

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Mar 7, 2011
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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