MONITOR-CKD5 - Multi-level Evaluation of Anaemia Treatment, Outcomes, and Determinants in Chronic Kidney Disease Stage 5
NCT ID: NCT01121237
Last Updated: 2016-04-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
2086 participants
OBSERVATIONAL
2010-02-28
2014-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Evaluate the Efficacy and Safety of Multiple Roxadustat Dosing Regimens for the Treatment of Anemia in Dialysis Participants With Chronic Kidney Disease
NCT04059913
An Observational Study of Mircera in Patients With Chronic Renal Anemia on Dialysis (CKD Stage V) or Not on Dialysis (CKD Stage III-IV)
NCT01667380
Open-label Pharmacokinetic Study of Iron Isomaltoside 1000 (Monofer®) Administered as Single Bolus Injections in Subjects With Stage 5 Chronic Kidney Disease on Dialysis Therapy (CKD-5D)
NCT01469078
Study of Haemodialysis Patients Switching From Aranesp to Biosimilar
NCT02191150
A Study of Intermittent Oral Dosing of ASP1517 in Peritoneal Dialysis Chronic Kidney Disease Patients With Anemia
NCT02780726
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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)
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
CKD5, renal anaemia, haemodialysis
CKD5, renal anaemia, haemodialysis receiving recombinant human erythropoietin alfa (biosimilar)
Recombinant human erythropoietin alfa (biosimilar)
Recombinant human erythropoietin alfa (biosimilar) commercially available as prescribed per treating physician
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Recombinant human erythropoietin alfa (biosimilar)
Recombinant human erythropoietin alfa (biosimilar) commercially available as prescribed per treating physician
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hexal AG
INDUSTRY
Sandoz
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
HEXAL AG
Role: STUDY_CHAIR
Hexal AG
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Sandoz Investigational Site
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
Ajaccio, , France
Sandoz Investigational Site
Dourlers, , France
Sandoz Investigational Site
Fourmies, , France
Sandoz Investigational Site
Lille, , France
Sandoz Investigational Site
Saint-Quentin, , France
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
Hoyerswerda, , Germany
Sandoz Investigational Site
Höchstadt an der Aisch, , 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
Nuremberg, , 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
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
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
Wołomin, , Poland
Sandoz Investigational Site
Bistriţa, , Romania
Sandoz Investigational Site
Brasov, , Romania
Sandoz Investigational Site
Brăila, , Romania
Sandoz Investigational Site
Bucharest, , Romania
Sandoz Investigational Site
Miercurea-Ciuc, , Romania
Sandoz Investigational Site
Odorheiu Secuiesc, , Romania
Sandoz Investigational Site
Reşiţa, , Romania
Sandoz Investigational Site
Roman, , Romania
Sandoz Investigational Site
TG. Jiu, , Romania
Sandoz Investigational Site
Maribor, , Slovenia
Sandoz Investigational Site
Šempeter pri Gorici, , Slovenia
Sandoz Investigational Site
Ávila, , Spain
Sandoz Investigational Site
León, , Spain
Sandoz Investigational Site
Seville, , Spain
Sandoz Investigational Site
Zamora, , Spain
Sandoz Investigational Site
Fribourg, , Switzerland
Sandoz Investigational Site
Lausanne, , Switzerland
Sandoz Investigational Site
Nyon, , Switzerland
Sandoz Investigational Site
Zurich, , Switzerland
Sandoz Investigational Site
Cambridge, , United Kingdom
Sandoz Investigational Site
Chester, , United Kingdom
Sandoz Investigational Site
Norwich, , United Kingdom
Sandoz Investigational Site
Plymouth, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
HX575-503
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.