MONITOR-CKD5 - Multi-level Evaluation of Anaemia Treatment, Outcomes, and Determinants in Chronic Kidney Disease Stage 5 (MONITOR-CKD5)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01121237 |
Recruitment Status
:
Completed
First Posted
: May 12, 2010
Last Update Posted
: April 6, 2016
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment |
---|---|
Chronic Kidney Disease End-stage Renal Disease Anaemia | Drug: Recombinant human erythropoietin alfa (biosimilar) |
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)
Study Type : | Observational |
Actual Enrollment : | 2086 participants |
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 |
Study Start Date : | February 2010 |
Actual Primary Completion Date : | November 2014 |
Actual Study Completion Date : | November 2014 |

Group/Cohort | Intervention/treatment |
---|---|
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
|
- 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 ]
- 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 ]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.

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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01121237

Study Chair: | HEXAL AG | Hexal AG |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Sandoz |
ClinicalTrials.gov Identifier: | NCT01121237 History of Changes |
Other Study ID Numbers: |
HX575-503 |
First Posted: | May 12, 2010 Key Record Dates |
Last Update Posted: | April 6, 2016 |
Last Verified: | April 2016 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Keywords provided by Sandoz:
chronic kidney disease end-stage renal disease renal anaemia epoetin alfa |
Additional relevant MeSH terms:
Anemia Kidney Diseases Renal Insufficiency, Chronic Kidney Failure, Chronic Hematologic Diseases |
Urologic Diseases Renal Insufficiency Epoetin Alfa Hematinics |