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

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ClinicalTrials.gov Identifier: NCT01940484
Recruitment Status : Completed
First Posted : September 12, 2013
Results First Posted : April 20, 2016
Last Update Posted : July 5, 2017
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment
Anemia Drug: Methoxy polyethylene glycol epoetin beta

Study Design
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Study Type : Observational
Actual Enrollment : 98 participants
Observational Model: Cohort
Time Perspective: Prospective
Official 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
Actual Study Start Date : August 31, 2009
Actual Primary Completion Date : July 31, 2012
Actual Study Completion Date : July 31, 2012

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Groups and Cohorts
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Group/Cohort Intervention/treatment
Chronic Renal Anemia Participants
Participants with chronic kidney disease and who are on hemodialysis and on methoxy polyethylene glycol epoetin beta as per physician's discretion for treatment of chronic renal anemia will be observed for a period of 6-12 months.
 Drug: Methoxy polyethylene glycol epoetin beta
Other Name: Mircera


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Participants with Stage V chronic kidney disease on hemodialysis with renal anemia receiving erythropoiesis-stimulating agent (ESA).
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01940484


Locations
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South Africa
Glynnwood Hospital
Benoni, South Africa, 1501
Universitas Private Hospital
Bloemfontein, South Africa, 9301
GVI Constantiaberg
Cape Town, South Africa, 7800
Groote Schuur Hospital; Renal Unit
Cape Town, South Africa, 7925
N1City Hospital
Cape Town, South Africa, 7925
Dr KB Parag & Raghubir Kidney and Dialysis Centre
Durban, South Africa, 4001
St Augustine Hospital / Chelmsford Medical Center; Nephrology
Durban, South Africa
Mayo Clinic
Johannesburg, South Africa, 1724
Sunninghill Hospital
Johannesburg, South Africa, 2157
Donald Gordon Medical Centre
Johannesburg, South Africa, 2193
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
More Information
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01940484    
Other Study ID Numbers: ML22344
First Posted: September 12, 2013    Key Record Dates
Results First Posted: April 20, 2016
Last Update Posted: July 5, 2017
Last Verified: May 2017
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Anemia
Hematologic Diseases
 Urologic Diseases
Renal Insufficiency
Epoetin Alfa
Hematinics