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

Purpose

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.

Condition	Intervention
Chronic Kidney Disease End-stage Renal Disease Anaemia	Drug: Recombinant human erythropoietin alfa (biosimilar)


Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
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

Resource links provided by NLM:

MedlinePlus related topics: Anemia Chronic Kidney Disease Dialysis Kidney Diseases Kidney Failure

Drug Information available for: Erythropoietin Epoetin Alfa

U.S. FDA Resources

Further study details as provided by Sandoz:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]
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.


Enrollment:	2084
Study Start Date:	November 2009
Study Completion Date:	November 2014
Primary Completion Date:	November 2014 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
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 Name: biosimilar epoetin alfa

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


Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

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

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01121237

Sponsors and Collaborators

Sandoz

Investigators


Study Chair:	Loreto Gesualdo	University of Bari (Bari, Italy)

More Information

No publications provided by Sandoz

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.


Responsible Party:	Sandoz
ClinicalTrials.gov Identifier:	NCT01121237 History of Changes
Other Study ID Numbers:	HX575-503
Study First Received:	May 6, 2010
Last Updated:	January 14, 2015
Health Authority:	Germany: Bundesinstitut für Arzneimittel und Medizinprodukte Abteilung Arzneimittelsicherheit France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé Spain: Agencia Española del Medicamento y Productos Sanitarios Romania: Agentia Nationala a Medicamentului Slovenia: JAVNA AGENCIJA REPUBLIKE SLOVENIJE ZA ZDRAVILA IN MEDICINSKE PRIPOMOČKE

Keywords provided by Sandoz:


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

Additional relevant MeSH terms:


Anemia Kidney Diseases Kidney Failure, Chronic Renal Insufficiency, Chronic Hematologic Diseases Renal Insufficiency	Urologic Diseases Epoetin alfa Hematinics Hematologic Agents Pharmacologic Actions Therapeutic Uses

ClinicalTrials.gov processed this record on February 27, 2015