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

Chronic Kidney Disease Clinical Trial

— MONITOR-CKD5  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01121237
• Other study ID #: HX575-503
• Status: Completed
• Phase: N/A
• First received: May 6, 2010
• Last updated: April 5, 2016
• Start date: February 2010
• Est. completion date: November 2014

Study information

• Verified date: April 2016
• Source: Sandoz
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesFrance: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santéSpain: Agencia Española de Medicamentos y Productos SanitariosRomania: National Medicines AgencySlovenia: JAVNA AGENCIJA REPUBLIKE SLOVENIJE ZA ZDRAVILA IN MEDICINSKE PRIPOMOCKE
• Study type: Observational

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2086
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Anaemia
• Anemia
• Chronic Kidney Disease
• End-stage Renal Disease
• Kidney Diseases
• Kidney Failure, Chronic
• Renal Insufficiency, Chronic

Intervention

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

Locations

Country	Name	City	State
Austria	Sandoz Investigational Site	Bregenz
Austria	Sandoz Investigational Site	Eisenstadt
Austria	Sandoz Investigational Site	Feldkirch
Austria	Sandoz Investigational Site	Nenzing
Austria	Sandoz Investigational Site	Vienna
France	Sandoz Investigational Site	Ajaccio
France	Sandoz Investigational Site	Dourlers
France	Sandoz Investigational Site	Fourmies Cedex
France	Sandoz Investigational Site	Lille
France	Sandoz Investigational Site	St. Quentin
Germany	Sandoz Investigational Site	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	Höchstadt
Germany	Sandoz Investigational Site	Hoyerswerda
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
Italy	Sandoz Investigational Site	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
Poland	Sandoz Investigational Site	Bialystok
Poland	Sandoz Investigational Site	Ciechanów
Poland	Sandoz Investigational Site	Gdansk
Poland	Sandoz Investigational Site	Lublin
Poland	Sandoz Investigational Site	Poznan
Poland	Sandoz Investigational Site	Rzeszów
Poland	Sandoz Investigational Site	Wolomin
Romania	Sandoz Investigational Site	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
Slovenia	Sandoz Investigational Site	Maribor
Slovenia	Sandoz Investigational Site	San Pietro
Spain	Sandoz Investigational Site	Avila
Spain	Sandoz Investigational Site	León
Spain	Sandoz Investigational Site	Sevilla
Spain	Sandoz Investigational Site	Zamora
Switzerland	Sandoz Investigational Site	Fribourg
Switzerland	Sandoz Investigational Site	Lausanne
Switzerland	Sandoz Investigational Site	Nyon
Switzerland	Sandoz Investigational Site	Zürich
United Kingdom	Sandoz Investigational Site	Cambridge
United Kingdom	Sandoz Investigational Site	Chester
United Kingdom	Sandoz Investigational Site	Norwich
United Kingdom	Sandoz Investigational Site	Plymouth

Sponsors (2)

Lead Sponsor	Collaborator
Sandoz	Hexal AG

Countries where clinical trial is conducted

Austria,  France,  Germany,  Italy,  Poland,  Romania,  Slovenia,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		every month for 24 months	No
Secondary	Number and proportion of participants with thrombovascular events, hospitalization,and mortality as measures of safety.	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	Yes