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MONITOR-CKD5 - Multi-level Evaluation of Anaemia Treatment, Outcomes, and Determinants in Chronic Kidney Disease Stage 5 (MONITOR-CKD5)

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ClinicalTrials.gov Identifier: NCT01121237
Recruitment Status : Completed
First Posted : May 12, 2010
Last Update Posted : April 6, 2016
Sponsor:
Collaborator:
Hexal AG
Information provided by (Responsible Party):
Sandoz

Study Description
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Brief Summary:
MONITOR-CKD5 is an observational, pharmaco-epidemiological study to evaluate the multi-level factors and outcomes associated with the treatment of renal anaemia with biosimilar epoetin alfa in Stage 5 CKD patients requiring haemodialysis.

Condition or disease Intervention/treatment
Chronic Kidney Disease End-stage Renal Disease Anaemia Drug: Recombinant human erythropoietin alfa (biosimilar)

Detailed Description:

See the following publication:

Gesualdo, L., London, G., Turner, M., Lee, C., MacDonald, K., Covic, A., Zaoui, P., Combe, C., Dellana, F., Muenzberg, M., & Abraham, I. (in press). A pharmacoepidemiological study of the multi-level determinants, predictors, and clinical outcomes of biosimilar epoetin alfa for renal anemia in hemodialysis patients: background and methodology of the MONITOR-CKD5 study. Internal and Emergency Medicine. (DOI 10.1007/511739-011-0622-7)


Study Design
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Study Type : Observational
Actual Enrollment : 2086 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: An International, Prospective, Open-label, Multicenter, Pharmacoepidemiological Study to Determine Predictors of Clinical Outcomes in Haemodialysis Patients With Anaemia Treated With Biosimilar Epoetin Alfa
Study Start Date : February 2010
Actual Primary Completion Date : November 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
CKD5, renal anaemia, haemodialysis
CKD5, renal anaemia, haemodialysis receiving recombinant human erythropoietin alfa (biosimilar)
 Drug: Recombinant human erythropoietin alfa (biosimilar)
Recombinant human erythropoietin alfa (biosimilar) commercially available as prescribed per treating physician
Other Name: biosimilar epoetin alfa


Outcome Measures
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Primary Outcome Measures :
  1. Haemoglobin outcomes, including haemoglobin levels in g/dL, change in haemoglobin levels over time (in g/dL and %), number and proportion of patients with haematopoietic response, number and proportion of patients reaching target haemoglobin levels. [ Time Frame: every month for 24 months ]

Secondary Outcome Measures :
  1. Number and proportion of participants with thrombovascular events, hospitalization,and mortality as measures of safety. [ Time Frame: Every month for 24 months + as occurring between visits ]
    Safety will be assessed every month for 24 months. In addition, any safety events reported by the patient or observed by clinicians in-between the monthly assessments will be recorded at the time of report or occurrence, and will be addressed at that time as necessary.


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:   Non-Probability Sample
Study Population
Patients with chronic kidney disease stage 5 with renal anemia and on haemodialysis
Criteria

Inclusion Criteria:

  • Male or female adults (age > 18 years).
  • On chronic haemodialysis due to end-stage renal disease (CKD5) of original or grafted kidneys for any duration.
  • Diagnosed with renal anaemia; i.e., anaemia due to impaired production of endogenous erythropoietin secondary to kidney failure.
  • Treated with commercially available intravenous EPOETIN ALFA HEXAL® per physician's best clinical judgment and under consideration of available guidance and evidence.
  • Female patients must be either post-menopausal for one year or surgically sterile or using effective contraceptive methods such as barrier method with spermicide or an intra-uterine device. Oral contraceptive use is allowed.
  • Informed written consent to participate in the study by patients or their legal guardian.

Exclusion Criteria:

  • Known sensitivity to EPOETIN ALFA HEXAL® or any other ESA.
  • Solid or hematological neoplasia being treated with chemotherapy.
  • Treatment with any myelosuppressant medications.
  • Blood transfusion dependency.
  • History of pure red cell aplasia.
  • Bleeding episode in 30 days prior to enrollment.
  • Orthopaedic surgery in 30 days prior to enrollment.
  • Patients with several medical condition(s) that in view of the investigator prohibits participation in the study.
  • Patients with willfully negligent nonadherence to their haemodialysis, medication, nutrition, and/or other recommended treatment regimens.
  • Use of any investigational agent in the 30 days prior to enrollment.
  • Women of childbearing potential not using the contraception method(s) described above.
  • Women who are breastfeeding.
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): NCT01121237


  Show 95 Study Locations
Sponsors and Collaborators
Sandoz
Hexal AG
Investigators
Study Chair: HEXAL AG Hexal AG
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Sandoz
ClinicalTrials.gov Identifier: NCT01121237     History of Changes
Other Study ID Numbers: HX575-503
First Posted: May 12, 2010    Key Record Dates
Last Update Posted: April 6, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Sandoz:
chronic kidney disease
end-stage renal disease
renal anaemia
epoetin alfa

Additional relevant MeSH terms:
Anemia
Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Hematologic Diseases
 Urologic Diseases
Renal Insufficiency
Epoetin Alfa
Hematinics