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Completed

NCT Number: NCT01309269

Observational Study to Investigate the Long-term Effects of MIRCERA in Clinical Routine

This observational study will assess the effect of long-term treatment with Mircera (methoxy polyethylene glycol-epoetin beta) in chronic kidney disease patients with renal anemia. Data will be collected from each patient for at least 24 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

Lüdenscheid, 58515, Germany

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
  • Patients with chronic kidney disease (CKD), stages IV and V
  • Treatment with Mircera according to label

Exclusion criteria

  • Pregnant or breastfeeding women

Treatment and study plan

Primary outcomes

  1. Hemoglobin Levels at Monthly Intervals

    Time frame: Prior to Day 1, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24

    Hemoglobin levels were measured as grams/deciliter (g/dL).

  2. Percentage of Participants Within Pre-defined Range of Hemoglobin Values

    Time frame: Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24

    Percentage of participants with hemoglobin values within the following pre-defined ranges is presented: 11-12 gram/deciliter (g/dL), 10-12 g/dL, 11-13 g/dL, and 10-13 g/dL.

  3. Average Methoxy Polyethylene Glycol-epoetin Beta Dose

    Time frame: Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24

    Average methoxy polyethylene glycol-epoetin beta dose per application by study month. Mean values were taken when more than 1 application was documented for a participant during the time period considered.

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

Non-interventional Study to Investigate the Long Term Effects of MIRCERA in Clinical Routine

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
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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