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NCT Number: NCT01940484

An Observational Study of Methoxy Polyethylene Glycol-Epoetin Beta (Mircera) in Stage V Chronic Kidney Disease Participants on Hemodialysis

This observational study will evaluate the efficacy and use of Methoxy polyethylene glycol-epoetin beta (Mircera) in participants with Stage V chronic kidney disease on hemodialysis receiving an erythropoietin prior to study entry. Attending physicians should have made the decision of placing the participant on methoxy polyethylene glycol epoetin beta in advance and not related to the study. The therapy will be administered by the attendant treating physician according to specifications in the package insert guidelines and to the routine of the site.

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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

Glynnwood Hospital, Benoni, South Africa

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Participants with chronic renal anemia with Stage V chronic kidney disease on hemodialysis and with a hemoglobin level of 10.0 - 13.0 grams per deciliter (g/dL)
  • Participants had to be receiving an ESA prior to entering the study
  • Female participants of childbearing age had to be using effective contraceptive methods

Exclusion criteria

  • As per approved package insert
  • Any contraindication to ESA treatment

Treatment and study plan

Methoxy polyethylene glycol epoetin beta

Drug

Other names: Mircera

Primary outcomes

  1. Number of Participants With Hemoglobin Values Within the Target Range of 11-12 g/dL at Visit 2 (Month 1)

    Time frame: Visit 2 (Month 1)

  2. Number of Participants With Hemoglobin Values Within the Target Range of 11-12 g/dL at Visit 3 (Month 2)

    Time frame: Visit 3 (Month 2)

  3. Number of Participants With Hemoglobin Values Within the Target Range of 11-12 g/dL at Visit 4 (Month 3)

    Time frame: Visit 4 (Month 3)

  4. Number of Participants With Hemoglobin Values Within the Target Range of 11-12 g/dL at Visit 5 (Month 4)

    Time frame: Visit 5 (Month 4)

  5. Number of Participants With Hemoglobin Values Within the Target Range of 11-12 g/dL at Visit 6 (Month 5)

    Time frame: Visit 6 (Month 5)

  6. Number of Participants With Hemoglobin Values Within the Target Range of 11-12 g/dL at Visit 7 (Month 6)

    Time frame: Visit 7 (Month 6)

  7. Mean Hemoglobin Value at Visit 2 (Month 1)

    Time frame: Visit 2 (Month 1)

  8. Mean Hemoglobin Value at Visit 3 (Month 2)

    Time frame: Visit 3 (Month 2)

  9. Mean Hemoglobin Value at Visit 4 (Month 3)

    Time frame: Visit 4 (Month 3)

  10. Mean Hemoglobin Value at Visit 5 (Month 4)

    Time frame: Visit 5 (Month 4)

  11. Mean Hemoglobin Value at Visit 6 (Month 5)

    Time frame: Visit 6 (Month 5)

  12. Mean Hemoglobin Value at Visit 7 (Month 6)

    Time frame: Visit 7 (Month 6)

Secondary outcomes

  1. Mean Methoxy Polyethylene Glycol-Epoetin Beta Dose During the Study

    Time frame: Visit 2 (Month 1), Visit 3 (Month 2), Visit 4 (Month 3), Visit 5 (Month 4), Visit 6 (Month 5), Visit 7 (Month 6)

  2. Number of Participants With Dose Adjustments of Methoxy Polyethylene Glycol-Epoetin Beta

    Time frame: Visit 2 (Month 1), Visit 3 (Month 2), Visit 4 (Month 3), Visit 5 (Month 4), Visit 6 (Month 5), Visit 7 (Month 6), Visit 8 (Month 7)

    Dose adjustment included dose increase or dose decrease with respect to previous visit's dose.

  3. Number of Participants Treated According to European Renal Best Practice Guideline (ERBPG) and National Kidney Function (NKF) Kidney Disease Outcomes Quality Initiative (NKF KDOQI) and Mircera Package Insert

    Time frame: Up to 6 months

    Number of participants who received treatment as per the guidelines specified by ERBPG, NKF KDOQI, and Mircera package insert were to be reported.

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

An Observational, Non-Interventional Cohort Study to Observe the Efficacy and Use of MIRCERA in the Treatment of Chronic Renal Anaemia in Patients With Chronic Kidney Disease Stage V on Haemodialysis

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Sep 12, 2013
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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