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

This study is currently recruiting participants.
Verified August 2011 by Matrix45
Information provided by:
Matrix45 Identifier:
First received: May 6, 2010
Last updated: August 9, 2011
Last verified: August 2011

MONITOR-CKD5 is an observational, pharmaco-epidemiological study to evaluate the multi-level factors and outcomes associated with the treatment of renal anaemia with BINOCRIT® (human recombinant epoetin α bio-similar ESA) in Stage 5 CKD patients requiring haemodialysis.

Condition Intervention
Chronic Kidney Disease
End-stage Renal Disease
Drug: Recombinant human erythropoietin alfa (biosimilar)

Study Type: Observational
Study Design: 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 Binocrit(r)

Resource links provided by NLM:

Further study details as provided by Matrix45:

Primary Outcome Measures:
  • 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 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number and proportion of participants with thrombovascular events, hospitalization,and mortality as measures of safety. [ Time Frame: Every month for 12 months + as occurring between visits ] [ Designated as safety issue: Yes ]
    Safety will be assessed every month for 12 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.

Estimated Enrollment: 1000
Study Start Date: November 2009
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
CKD5, renal anaemia, haemodialysis Drug: Recombinant human erythropoietin alfa (biosimilar)
Commercially available as prescribed per treating physician
Other Name: Binocrit(r)

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)


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with chronic kidney disease stage 5 with renal anemia and on haemodialysis


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 BINOCRIT® per physician's best clinical judgment.
  • Haemoglobin level 10-12 g/dL
  • 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 BINOCRIT® 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.
  Contacts and Locations
Please refer to this study by its identifier: NCT01121237

Dr. med. Sven Herrnberger Recruiting
Viersen, D, Germany, 41751
Contact: Ivo Abraham, PhD    +1.303.997.2697   
Sponsors and Collaborators
Study Chair: Loreto Gesualdo University of Bari (Bari, Italy)
  More Information

No publications provided by Matrix45

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Ivo Abraham, Matrix Identifier: NCT01121237     History of Changes
Other Study ID Numbers: HX575-503
Study First Received: May 6, 2010
Last Updated: August 9, 2011
Health Authority: Germany: Ethics Commission

Keywords provided by Matrix45:
chronic kidney disease
end-stage renal disease
renal anaemia
epoetin alfa

Additional relevant MeSH terms:
Kidney Failure, Chronic
Kidney Diseases
Renal Insufficiency, Chronic
Hematologic Diseases
Urologic Diseases
Renal Insufficiency
Epoetin Alfa
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions processed this record on April 17, 2014