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NCT Number: NCT01121237

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

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.

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Key information

Conditions

Chronic Kidney Disease Anaemia Anemia Chronic Disease Disease Attributes End-stage Renal Disease Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hematologic Diseases Hemic and Lymphatic Diseases Kidney Diseases Kidney Failure, Chronic 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

Sandoz Investigational Site, Bregenz, Austria

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About this study

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)

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Recombinant human erythropoietin alfa (biosimilar)

Drug

Recombinant human erythropoietin alfa (biosimilar) commercially available as prescribed per treating physician

Other names: biosimilar epoetin alfa

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Sandoz

Industry

Collaborators

  • Hexal AG

Registry information

Official study 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

Acronym: MONITOR-CKD5

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
May 12, 2010
Registry last updated
Apr 6, 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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