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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2011 by Matrix45
Sponsor:
Collaborator:
Sandoz
Information provided by:
Matrix45
ClinicalTrials.gov Identifier:
NCT01121237
First received: May 6, 2010
Last updated: August 9, 2011
Last verified: August 2011
  Purpose

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
Anaemia
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)

  Eligibility

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

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 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01121237

Locations
Germany
Dr. med. Sven Herrnberger Recruiting
Viersen, D, Germany, 41751
Contact: Ivo Abraham, PhD    +1.303.997.2697    iabraham@matrix45.com   
Sponsors and Collaborators
Matrix45
Sandoz
Investigators
Study Chair: Loreto Gesualdo University of Bari (Bari, Italy)
  More Information

No publications provided by Matrix45

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ivo Abraham, Matrix
ClinicalTrials.gov 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:
Anemia
Kidney Diseases
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Hematologic Diseases
Urologic Diseases
Renal Insufficiency
Epoetin Alfa
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 23, 2014