Clinical trial NCT01121237: MONITOR-CKD5 - Multi-level Evaluation of Anaemia Treatment, Outcomes, and Determinants in Chronic Kidney Disease Stage 5
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Kidney Disease
End-stage Renal Disease
Anaemia
Keywords: chronic kidney disease
end-stage renal disease
renal anaemia
epoetin alfa
Lead sponsor: Sandoz
Sponsor class: INDUSTRY
Collaborators: name: Hexal AG
First posted: 2010-05-12
Enrollment: 2086
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with chronic kidney disease stage 5 with renal anemia and on haemodialysis

Brief 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.

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 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 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.

Primary outcomes:
measure: 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.
timeFrame: every month for 24 months
Secondary outcomes:
measure: Number and proportion of participants with thrombovascular events, hospitalization,and mortality as measures of safety.
timeFrame: Every month for 24 months + as occurring between visits
Other outcomes:
Locations:
city: Bregenz
country: Austria
facility: Sandoz Investigational Site
city: Eisenstadt
country: Austria
facility: Sandoz Investigational Site
city: Feldkirch
country: Austria
facility: Sandoz Investigational Site
city: Nenzing
country: Austria
facility: Sandoz Investigational Site
city: Vienna
country: Austria
facility: Sandoz Investigational Site
city: Ajaccio
country: France
facility: Sandoz Investigational Site
city: Dourlers
country: France
facility: Sandoz Investigational Site
city: Fourmies Cedex
country: France
facility: Sandoz Investigational Site
city: Lille
country: France
facility: Sandoz Investigational Site
city: St. Quentin
country: France
facility: Sandoz Investigational Site
city: Alsfeld
country: Germany
facility: Sandoz Investigational Site
city: Arnstadt
country: Germany
facility: Sandoz Investigational Site
city: Bad Neustadt a. d. Saale
country: Germany
facility: Sandoz Investigational Site
city: Bassum
country: Germany
facility: Sandoz Investigational Site
city: Berlin
country: Germany
facility: Sandoz Investigational Site
city: Bochum
country: Germany
facility: Sandoz Investigational Site
city: Cloppenburg
country: Germany
facility: Sandoz Investigational Site
city: Cochem
country: Germany
facility: Sandoz Investigational Site
city: Darmstadt
country: Germany
facility: Sandoz Investigational Site
city: Dresden
country: Germany
facility: Sandoz Investigational Site
city: Duisburg
country: Germany
facility: Sandoz Investigational Site
city: Düsseldorf
country: Germany
facility: Sandoz Investigational Site
city: Erftstadt
country: Germany
facility: Sandoz Investigational Site
city: Georgsmarienhütte
country: Germany
facility: Sandoz Investigational Site
city: Greifswald
country: Germany
facility: Sandoz Investigational Site
city: Güstrow
country: Germany
facility: Sandoz Investigational Site
city: Herne
country: Germany
facility: Sandoz Investigational Site
city: Herzberg
country: Germany
facility: Sandoz Investigational Site
city: Hoyerswerda
country: Germany
facility: Sandoz Investigational Site
city: Höchstadt
country: Germany
facility: Sandoz Investigational Site
city: Kamen
country: Germany
facility: Sandoz Investigational Site
city: Kiel
country: Germany
facility: Sandoz Investigational Site
city: Magdeburg
country: Germany
facility: Sandoz Investigational Site
city: Mettmann
country: Germany
facility: Sandoz Investigational Site
city: Munich
country: Germany
facility: Sandoz Investigational Site
city: Nürnberg
country: Germany
facility: Sandoz Investigational Site
city: Osnabrück
country: Germany
facility: Sandoz Investigational Site
city: Pinneberg
country: Germany
facility: Sandoz Investigational Site
city: Quedlinburg
country: Germany
facility: Sandoz Investigational Site
city: Remagen
country: Germany
facility: Sandoz Investigational Site
city: Rendsburg
country: Germany
facility: Sandoz Investigational Site
city: Schrobenhausen
country: Germany
facility: Sandoz Investigational Site
city: Schwabach
country: Germany
facility: Sandoz Investigational Site
city: Seehausen
country: Germany
facility: Sandoz Investigational Site
city: Viersen
country: Germany
facility: Sandoz Investigational Site
city: Wetzlar
country: Germany
facility: Sandoz Investigational Site
city: Wilhelmshaven
country: Germany
facility: Sandoz Investigational Site
city: Acireale
country: Italy
facility: Sandoz Investigational Site
city: Altamura
country: Italy
facility: Sandoz Investigational Site
city: Arenzano
country: Italy
facility: Sandoz Investigational Site
city: Arezzo
country: Italy
facility: Sandoz Investigational Site
city: Biella
country: Italy
facility: Sandoz Investigational Site
city: Catania
country: Italy
facility: Sandoz Investigational Site
city: Chivasso
country: Italy
facility: Sandoz Investigational Site
city: Cinisello Balsamo
country: Italy
facility: Sandoz Investigational Site
city: Cirié
country: Italy
facility: Sandoz Investigational Site
city: Cosenza
country: Italy
facility: Sandoz Investigational Site
city: Cuneo
country: Italy
facility: Sandoz Investigational Site
city: Ivrea
country: Italy
facility: Sandoz Investigational Site
city: Montevarchi
country: Italy
facility: Sandoz Investigational Site
city: Pavia
country: Italy
facility: Sandoz Investigational Site
city: Pontecorvo
country: Italy
facility: Sandoz Investigational Site
city: Putignano
country: Italy
facility: Sandoz Investigational Site
city: Roma
country: Italy
facility: Sandoz Investigational Site
city: Torino
country: Italy
facility: Sandoz Investigational Site
city: Bialystok
country: Poland
facility: Sandoz Investigational Site
city: Ciechanów
country: Poland
facility: Sandoz Investigational Site
city: Gdańsk
country: Poland
facility: Sandoz Investigational Site
city: Lublin
country: Poland
facility: Sandoz Investigational Site
city: Poznań
country: Poland
facility: Sandoz Investigational Site
city: Rzeszów
country: Poland
facility: Sandoz Investigational Site
city: Wołomin
country: Poland
facility: Sandoz Investigational Site
city: Bistrita
country: Romania
facility: Sandoz Investigational Site
city: Braila
country: Romania
facility: Sandoz Investigational Site
city: Brasov
country: Romania
facility: Sandoz Investigational Site
city: Bucharest
country: Romania
facility: Sandoz Investigational Site
city: Miercurea Ciuc
country: Romania
facility: Sandoz Investigational Site
city: Odorheiu Secuiesc
country: Romania
facility: Sandoz Investigational Site
city: Resita
country: Romania
facility: Sandoz Investigational Site
city: Roman
country: Romania
facility: Sandoz Investigational Site
city: TG. Jiu
country: Romania
facility: Sandoz Investigational Site
city: Maribor
country: Slovenia
facility: Sandoz Investigational Site
city: San Pietro
country: Slovenia
facility: Sandoz Investigational Site
city: Avila
country: Spain
facility: Sandoz Investigational Site
city: León
country: Spain
facility: Sandoz Investigational Site
city: Sevilla
country: Spain
facility: Sandoz Investigational Site
city: Zamora
country: Spain
facility: Sandoz Investigational Site
city: Fribourg
country: Switzerland
facility: Sandoz Investigational Site
city: Lausanne
country: Switzerland
facility: Sandoz Investigational Site
city: Nyon
country: Switzerland
facility: Sandoz Investigational Site
city: Zürich
country: Switzerland
facility: Sandoz Investigational Site
city: Cambridge
country: United Kingdom
facility: Sandoz Investigational Site
city: Chester
country: United Kingdom
facility: Sandoz Investigational Site
city: Norwich
country: United Kingdom
facility: Sandoz Investigational Site
city: Plymouth
country: United Kingdom
facility: Sandoz Investigational Site
Study officials:
affiliation: Hexal AG
name: HEXAL AG
role: STUDY_CHAIR
References:
citation: Combe C, Mann J, Goldsmith D, Dellanna F, Zaoui P, London G, Denhaerynck K, Krendyukov A, Abraham I, MacDonald K. Potential life-years gained over a 5-year period by correcting DOPPS-identified modifiable practices in haemodialysis: results from the European MONITOR-CKD5 study. BMC Nephrol. 2019 Mar 5;20(1):81. doi: 10.1186/s12882-019-1251-z.
citation: Gesualdo L, London G, Turner M, Lee C, Macdonald K, Goldsmith D, Covic A, Zaoui P, Combe C, Mann J, Dellanna F, Muenzberg M, Abraham I. A pharmacoepidemiological study of the multi-level determinants, predictors, and clinical outcomes of biosimilar epoetin alfa for renal anaemia in haemodialysis patients: background and methodology of the MONITOR-CKD5 study. Intern Emerg Med. 2013 Aug;8(5):389-99. doi: 10.1007/s11739-011-0622-7. Epub 2011 May 18.