Trial record 18 of 1370 for:
Open Studies | "Kidney Diseases"
MONITOR-CKD5 - Multi-level Evaluation of Anaemia Treatment, Outcomes, and Determinants in Chronic Kidney Disease Stage 5
This study is currently recruiting participants.
Verified August 2011 by Matrix45
Sponsor:
Matrix45
Collaborator:
Sandoz
Information provided by:
Matrix45
ClinicalTrials.gov Identifier:
NCT01121237
First received: May 6, 2010
Last updated: August 9, 2011
Last verified: August 2011
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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 BINOCRIT® (human recombinant epoetin α bio-similar ESA) 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 Binocrit(r) |
Resource links provided by NLM:
Further study details as provided by Matrix45:
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 12 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 12 months + as occurring between visits ] [ Designated as safety issue: Yes ]Safety will be assessed every month for 12 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.
| Estimated Enrollment: | 1000 |
| Study Start Date: | November 2009 |
| Estimated Study Completion Date: | October 2014 |
| Estimated Primary Completion Date: | October 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| CKD5, renal anaemia, haemodialysis |
Drug: Recombinant human erythropoietin alfa (biosimilar)
Commercially available as prescribed per treating physician
Other Name: Binocrit(r)
|
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 BINOCRIT® per physician's best clinical judgment.
- Haemoglobin level 10-12 g/dL
- 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 BINOCRIT® 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01121237
Locations
| Germany | |
| Dr. med. Sven Herrnberger | Recruiting |
| Viersen, D, Germany, 41751 | |
| Contact: Ivo Abraham, PhD +1.303.997.2697 iabraham@matrix45.com | |
Sponsors and Collaborators
Matrix45
Sandoz
Investigators
| Study Chair: | Loreto Gesualdo | University of Bari (Bari, Italy) |
More Information
No publications provided
| Responsible Party: | Ivo Abraham, Matrix |
| ClinicalTrials.gov Identifier: | NCT01121237 History of Changes |
| Other Study ID Numbers: | HX575-503 |
| Study First Received: | May 6, 2010 |
| Last Updated: | August 9, 2011 |
| Health Authority: | Germany: Ethics Commission |
Keywords provided by Matrix45:
|
chronic kidney disease end-stage renal disease renal anaemia epoetin alfa |
Additional relevant MeSH terms:
|
Kidney Diseases Anemia Kidney Failure, Chronic Renal Insufficiency, Chronic Hematologic Diseases Urologic Diseases |
Renal Insufficiency Epoetin Alfa Hematinics Hematologic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013