Trials / Completed
CompletedNCT01121237
MONITOR-CKD5 - Multi-level Evaluation of Anaemia Treatment, Outcomes, and Determinants in Chronic Kidney Disease Stage 5
An International, Prospective, Open-label, Multicenter, Pharmacoepidemiological Study to Determine Predictors of Clinical Outcomes in Haemodialysis Patients With Anaemia Treated With Biosimilar Epoetin Alfa
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 2,086 (actual)
- Sponsor
- Sandoz · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
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)
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Recombinant human erythropoietin alfa (biosimilar) | Recombinant human erythropoietin alfa (biosimilar) commercially available as prescribed per treating physician |
Timeline
- Start date
- 2010-02-01
- Primary completion
- 2014-11-01
- Completion
- 2014-11-01
- First posted
- 2010-05-12
- Last updated
- 2016-04-06
Locations
95 sites across 10 countries: Austria, France, Germany, Italy, Poland, Romania, Slovenia, Spain, Switzerland, United Kingdom
Source: ClinicalTrials.gov record NCT01121237. Inclusion in this directory is not an endorsement.