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MONITOR-CKD5 - Multi-level Evaluation of Anaemia Treatment, Outcomes, and Determinants in Chronic Kidney Disease Stage 5 (MONITOR-CKD5)
This study has been completed.
Sponsor:
Sandoz
Collaborator:
Hexal AG
Information provided by (Responsible Party):
Sandoz
ClinicalTrials.gov Identifier:
NCT01121237
First received: May 6, 2010
Last updated: April 5, 2016
Last verified: April 2016
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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:
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 ]
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 ]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: | 2086 |
| Study Start Date: | February 2010 |
| 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 (Adult, Senior) |
| Sexes Eligible for Study: | All |
| 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
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01121237
Show 95 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01121237
Show 95 Study Locations
Sponsors and Collaborators
Sandoz
Hexal AG
Investigators
| Study Chair: | HEXAL AG | Hexal AG |
More Information
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 |
| Study First Received: | May 6, 2010 |
| Last Updated: | April 5, 2016 |
| Individual Participant Data | |
| 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 |
ClinicalTrials.gov processed this record on June 23, 2017