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

April 5, 2016 updated by: Sandoz

An International, Prospective, Open-label, Multicenter, Pharmacoepidemiological Study to Determine Predictors of Clinical Outcomes in Haemodialysis Patients With Anaemia Treated With Biosimilar Epoetin Alfa

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

2086

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Bregenz, Austria
        • Sandoz Investigational Site
      • Eisenstadt, Austria
        • Sandoz Investigational Site
      • Feldkirch, Austria
        • Sandoz Investigational Site
      • Nenzing, Austria
        • Sandoz Investigational Site
      • Vienna, Austria
        • Sandoz Investigational Site
  • France
      • Ajaccio, France
        • Sandoz Investigational Site
      • Dourlers, France
        • Sandoz Investigational Site
      • Fourmies Cedex, France
        • Sandoz Investigational Site
      • Lille, France
        • Sandoz Investigational Site
      • St. Quentin, France
        • Sandoz Investigational Site
  • Germany
      • Alsfeld, Germany
        • Sandoz Investigational Site
      • Arnstadt, Germany
        • Sandoz Investigational Site
      • Bad Neustadt a. d. Saale, Germany
        • Sandoz Investigational Site
      • Bassum, Germany
        • Sandoz Investigational Site
      • Berlin, Germany
        • Sandoz Investigational Site
      • Bochum, Germany
        • Sandoz Investigational Site
      • Cloppenburg, Germany
        • Sandoz Investigational Site
      • Cochem, Germany
        • Sandoz Investigational Site
      • Darmstadt, Germany
        • Sandoz Investigational Site
      • Dresden, Germany
        • Sandoz Investigational Site
      • Duisburg, Germany
        • Sandoz Investigational Site
      • Düsseldorf, Germany
        • Sandoz Investigational Site
      • Erftstadt, Germany
        • Sandoz Investigational Site
      • Georgsmarienhütte, Germany
        • Sandoz Investigational Site
      • Greifswald, Germany
        • Sandoz Investigational Site
      • Güstrow, Germany
        • Sandoz Investigational Site
      • Herne, Germany
        • Sandoz Investigational Site
      • Herzberg, Germany
        • Sandoz Investigational Site
      • Hoyerswerda, Germany
        • Sandoz Investigational Site
      • Höchstadt, Germany
        • Sandoz Investigational Site
      • Kamen, Germany
        • Sandoz Investigational Site
      • Kiel, Germany
        • Sandoz Investigational Site
      • Magdeburg, Germany
        • Sandoz Investigational Site
      • Mettmann, Germany
        • Sandoz Investigational Site
      • Munich, Germany
        • Sandoz Investigational Site
      • Nürnberg, Germany
        • Sandoz Investigational Site
      • Osnabrück, Germany
        • Sandoz Investigational Site
      • Pinneberg, Germany
        • Sandoz Investigational Site
      • Quedlinburg, Germany
        • Sandoz Investigational Site
      • Remagen, Germany
        • Sandoz Investigational Site
      • Rendsburg, Germany
        • Sandoz Investigational Site
      • Schrobenhausen, Germany
        • Sandoz Investigational Site
      • Schwabach, Germany
        • Sandoz Investigational Site
      • Seehausen, Germany
        • Sandoz Investigational Site
      • Viersen, Germany
        • Sandoz Investigational Site
      • Wetzlar, Germany
        • Sandoz Investigational Site
      • Wilhelmshaven, Germany
        • Sandoz Investigational Site
  • Italy
      • Acireale, Italy
        • Sandoz Investigational Site
      • Altamura, Italy
        • Sandoz Investigational Site
      • Arenzano, Italy
        • Sandoz Investigational Site
      • Arezzo, Italy
        • Sandoz Investigational Site
      • Biella, Italy
        • Sandoz Investigational Site
      • Catania, Italy
        • Sandoz Investigational Site
      • Chivasso, Italy
        • Sandoz Investigational Site
      • Cinisello Balsamo, Italy
        • Sandoz Investigational Site
      • Cirié, Italy
        • Sandoz Investigational Site
      • Cosenza, Italy
        • Sandoz Investigational Site
      • Cuneo, Italy
        • Sandoz Investigational Site
      • Ivrea, Italy
        • Sandoz Investigational Site
      • Montevarchi, Italy
        • Sandoz Investigational Site
      • Pavia, Italy
        • Sandoz Investigational Site
      • Pontecorvo, Italy
        • Sandoz Investigational Site
      • Putignano, Italy
        • Sandoz Investigational Site
      • Roma, Italy
        • Sandoz Investigational Site
      • Torino, Italy
        • Sandoz Investigational Site
  • Poland
      • Bialystok, Poland
        • Sandoz Investigational Site
      • Ciechanów, Poland
        • Sandoz Investigational Site
      • Gdańsk, Poland
        • Sandoz Investigational Site
      • Lublin, Poland
        • Sandoz Investigational Site
      • Poznań, Poland
        • Sandoz Investigational Site
      • Rzeszów, Poland
        • Sandoz Investigational Site
      • Wołomin, Poland
        • Sandoz Investigational Site
  • Romania
      • Bistrita, Romania
        • Sandoz Investigational Site
      • Braila, Romania
        • Sandoz Investigational Site
      • Brasov, Romania
        • Sandoz Investigational Site
      • Bucharest, Romania
        • Sandoz Investigational Site
      • Miercurea Ciuc, Romania
        • Sandoz Investigational Site
      • Odorheiu Secuiesc, Romania
        • Sandoz Investigational Site
      • Resita, Romania
        • Sandoz Investigational Site
      • Roman, Romania
        • Sandoz Investigational Site
      • TG. Jiu, Romania
        • Sandoz Investigational Site
  • Slovenia
      • Maribor, Slovenia
        • Sandoz Investigational Site
      • San Pietro, Slovenia
        • Sandoz Investigational Site
  • Spain
      • Avila, Spain
        • Sandoz Investigational Site
      • León, Spain
        • Sandoz Investigational Site
      • Sevilla, Spain
        • Sandoz Investigational Site
      • Zamora, Spain
        • Sandoz Investigational Site
  • Switzerland
      • Fribourg, Switzerland
        • Sandoz Investigational Site
      • Lausanne, Switzerland
        • Sandoz Investigational Site
      • Nyon, Switzerland
        • Sandoz Investigational Site
      • Zürich, Switzerland
        • Sandoz Investigational Site
  • United Kingdom
      • Cambridge, United Kingdom
        • Sandoz Investigational Site
      • Chester, United Kingdom
        • Sandoz Investigational Site
      • Norwich, United Kingdom
        • Sandoz Investigational Site
      • Plymouth, United Kingdom
        • Sandoz Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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 Names:
  • biosimilar epoetin alfa

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
every month for 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Every month for 24 months + as occurring between visits

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sandoz

Collaborators

Hexal AG

Investigators

  • Study Chair: Hexal AG, Hexal AG

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (Actual)

November 1, 2014

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

May 6, 2010

First Submitted That Met QC Criteria

May 10, 2010

First Posted (Estimate)

May 12, 2010

Study Record Updates

Last Update Posted (Estimate)

April 6, 2016

Last Update Submitted That Met QC Criteria

April 5, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HX575-503

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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