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

NCT01121237 | Completed DMC

• 1 other identifier: HX575-503
• Study Type: observational
• Target: 2,086
• Locations: 10 countries
• Sites: 95

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.

Conditions

Chronic Kidney Disease; End-stage Renal Disease; Anaemia

Keywords

chronic kidney disease; end-stage renal disease; renal anaemia; epoetin alfa

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Number and proportion of participants with thrombovascular events, hospitalization,and mortality as measures of safety.

  Every month for 24 months + as occurring between visits

Study Arms (1)

CKD5, renal anaemia, haemodialysis

CKD5, renal anaemia, haemodialysis receiving recombinant human erythropoietin alfa (biosimilar)

Drug: Recombinant human erythropoietin alfa (biosimilar)

Interventions

Recombinant human erythropoietin alfa (biosimilar) DRUG

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

Also known as: biosimilar epoetin alfa

CKD5, renal anaemia, haemodialysis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sandoz: lead
• Hexal AG: collaborator

Study Sites (95)

Sandoz Investigational Site

Bregenz, Austria

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Eisenstadt, Austria

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Feldkirch, Austria

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Nenzing, Austria

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Vienna, Austria

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Ajaccio, France

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Dourlers, France

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Fourmies, France

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Lille, France

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Saint-Quentin, France

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Alsfeld, Germany

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Arnstadt, Germany

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Bad Neustadt A. D. Saale, Germany

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Bassum, Germany

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Berlin, Germany

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Bochum, Germany

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Cloppenburg, Germany

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Cochem, Germany

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Darmstadt, Germany

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Dresden, Germany

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Duisburg, Germany

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Düsseldorf, Germany

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Erftstadt, Germany

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Georgsmarienhütte, Germany

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Greifswald, Germany

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Güstrow, Germany

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Herne, Germany

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Herzberg, Germany

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Hoyerswerda, Germany

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Höchstadt an der Aisch, Germany

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Kamen, Germany

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Kiel, Germany

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Magdeburg, Germany

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Mettmann, Germany

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Munich, Germany

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Nuremberg, Germany

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Osnabrück, Germany

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Pinneberg, Germany

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Quedlinburg, Germany

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Remagen, Germany

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Rendsburg, Germany

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Schrobenhausen, Germany

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Schwabach, Germany

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Seehausen, Germany

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Viersen, Germany

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Wetzlar, Germany

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Wilhelmshaven, Germany

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Acireale, Italy

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Altamura, Italy

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Arenzano, Italy

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Arezzo, Italy

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Biella, Italy

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Catania, Italy

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Chivasso, Italy

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Cinisello Balsamo, Italy

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Cirié, Italy

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Cosenza, Italy

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Cuneo, Italy

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Ivrea, Italy

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Montevarchi, Italy

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Pavia, Italy

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Pontecorvo, Italy

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Putignano, Italy

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Roma, Italy

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Torino, Italy

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Bialystok, Poland

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Ciechanów, Poland

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Gdansk, Poland

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Lublin, Poland

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Poznan, Poland

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Rzeszów, Poland

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Wołomin, Poland

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Bistriţa, Romania

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Brasov, Romania

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Brăila, Romania

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Bucharest, Romania

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Miercurea-Ciuc, Romania

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Odorheiu Secuiesc, Romania

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Reşiţa, Romania

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Roman, Romania

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TG. Jiu, Romania

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Maribor, Slovenia

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Šempeter pri Gorici, Slovenia

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Ávila, Spain

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León, Spain

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Seville, Spain

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Zamora, Spain

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Fribourg, Switzerland

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Lausanne, Switzerland

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Nyon, Switzerland

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Zurich, Switzerland

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Cambridge, United Kingdom

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Chester, United Kingdom

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Sandoz Investigational Site

Norwich, United Kingdom

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Sandoz Investigational Site

Plymouth, United Kingdom

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Related Publications (2)

• 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.

  PMID: 30836953 DERIVED

• 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.

  PMID: 21590439 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Kidney Failure, Chronic; Anemia

Interventions

Biosimilar Pharmaceuticals

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Biological Products; Complex Mixtures

Study Officials

• HEXAL AG

  Hexal AG

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2010
• First Posted: May 12, 2010
• Study Start: February 1, 2010
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: April 6, 2016

Record last verified: 2016-04

Locations

SL (2); PL (7); IT (18); CH (4); GB (4); RO (9); FR (5); AU (5); DE (37); ES (4)