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NCT Number: NCT01318512

An Observational Study of Mircera (Methoxy Polyethylene Glycol-epoetin Beta) in Patients With Chronic Kidney Disease Not On Dialysis

This observational, prospective, multicenter study will describe the mean dose of Mircera (methoxy polyethylene glycol-epoetin beta) and the hemoglobin levels in patients with chronic kidney disease. Patients are not on dialysis and are naive to, or have received erythropoiesis stimulating agent treatment. Data will be collected for 10 months.

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Key information

Conditions

Kidney Disease, Chronic Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Nemocnice Novy Jicin; Dialyzacni Stredisko

Nový Jičín, 741 11, Czechia

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adults patients, >/=18 years of age
  • Presence of chronic kidney disease (Stage 3-4)

Exclusion criteria

  • Participation in another clinical study

Treatment and study plan

Primary outcomes

  1. Average Dose of MIRCERA at Entry Level

    Time frame: Baseline

    The average dose of MIRCERA, measured in micrograms (µg) at entry level was reported.

  2. Average Dose of MIRCERA During Titration Period Month 1

    Time frame: Month 1

    The average dose of MIRCERA, measured in microgram (µg) at each month interval during the titration period was reported.

  3. Average Dose of MIRCERA During Titration Period Month 2

    Time frame: Month 2

    The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the titration period was reported.

  4. Average Dose of MIRCERA During Titration Period Month 3

    Time frame: Month 3

    The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the titration period was reported.

  5. Average Dose of MIRCERA During Titration Period Month 4

    Time frame: Month 4

    The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the titration period was reported.

  6. Average Dose of MIRCERA During Maintenance Period Month 1

    Time frame: Month 5 (Maintenance Period Month 1)

    The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the maintenance period was reported.

  7. Average Dose of MIRCERA During Maintenance Period Month 2

    Time frame: Month 6 (Maintenance Period Month 2)

    The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the maintenance period was reported.

  8. Average Dose of MIRCERA During Maintenance Period Month 3

    Time frame: Month 7 (Maintenance Period Month 3)

    The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the maintenance period was reported.

  9. Average Dose of MIRCERA During Maintenance Period Month 4

    Time frame: Month 8 (Maintenance Period Month 4)

    The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the maintenance period was reported.

  10. Average Dose of MIRCERA During Maintenance Period Month 5

    Time frame: Month 9 (Maintenance Period Month 5)

    The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the maintenance period was reported.

  11. Average Dose of MIRCERA During Maintenance Period Month 6

    Time frame: Month 10 (Maintenance Period Month 6)

    The average dose of MIRCERA, measured in micrograms (µg) at each month interval during the maintenance period was reported.

Secondary outcomes

  1. The Mean Hemoglobin (Hb) Level During Titration Period

    Time frame: Baseline, Month 1, 2, 3, 4

    The hemoglobin level was measured in grams per liter (g/L) at entry level and after each month of treatment with MIRCERA. The study did not distinguish between erythropoiesis stimulating agent naive and erythropoiesis stimulating agent treated participants, and collected the overall data (Hb level) before/after administration of MIRCERA.

  2. The Mean Hemoglobin (Hb) Level During Maintenance Period

    Time frame: Month 5, 6, 7, 8, 9, 10

    The hemoglobin level was measured in grams per liter (g/L) after each month of treatment with MIRCERA. The study did not distinguish between erythropoiesis stimulating agent naive and erythropoiesis stimulating agent treated participants, and collected the overall data (Hb level) before/after administration of MIRCERA

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

The Dosage of MIRCERA in the Treatment of Renal Anaemia in Patients With Chronic Renal Disease Who do Not Undergo Haemodialysis in Clinical Practice

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Mar 18, 2011
Registry last updated
Jul 5, 2017

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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