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Sponsors and Collaborators: |
Consorzio Mario Negri Sud Drug Italian Agency (AIFA)- Ministry of Health |
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Information provided by: | Consorzio Mario Negri Sud |
ClinicalTrials.gov Identifier: | NCT00827021 |
Anaemia is a risk factor for death, cardiac-cerebrovascular events and poor quality of life in patients with chronic kidney disease (CKD). Erythropoietin Stimulating Agents (ESAs) are the most used treatment option.
The purpose of this study is to determine the benefits and harms of different ESA doses therapeutic strategy for the management of anaemia of end stage kidney disease (ESKD).
Condition | Intervention | Phase |
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Kidney Failure, Chronic |
Drug: Erythropoiesis Stimulating Agents (ESAs): epoetin alfa, beta or any other epoetin in equivalent dose. |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Effects of the Dose of Erythropoiesis Stimulating Agents on Cardiac-Cerebrovascular Outcomes Quality of Life and Costs in Hemodialysis Patients. The Clinical Evaluation of the DOSe of Erythropoietins (C.E. DOSE) Trial |
Estimated Enrollment: | 2204 |
Arms | Assigned Interventions |
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1 low dose: Experimental |
Drug: Erythropoiesis Stimulating Agents (ESAs): epoetin alfa, beta or any other epoetin in equivalent dose.
4000 IU/week I.V. Until the end of the trial
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2 high dose: Active Comparator |
Drug: Erythropoiesis Stimulating Agents (ESAs): epoetin alfa, beta or any other epoetin in equivalent dose.
18000 IU/week I.V. Until the end of the trial
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Phase III pragmatic, randomized-controlled trial comparing different doses of ESAs in patients with renal anaemia.
Study Sample:
Total of 2204 participants from a Italy
Background and Rationale:
Anaemia is a risk factor for death, cardiac-cerebrovascular events and poor quality of life in patients with chronic kidney disease (CKD). Erythropoietin Stimulating Agents (ESA) are the most used treatment option. In observational studies higher haemoglobin (Hb) levels (around 10-13 g/dL) are associated with improved survival and quality of life compared to lower Hb levels (around 9 g/dL). Randomized studies have found that higher Hb targets, achieved and maintained with ESA, cause an increased risk of death, mainly due to adverse cardiac-cerebrovascular outcomes. It is possible that such effect is mediated by ESA dose. This hypothesis has not been formally tested and is the aim of the Clinical Evaluation of the DOSe of Erythropoietins (CEDOSE) trial.
CEDOSE is the first independent multicentre trial exploring the benefits and harms of different ESA doses therapeutic strategy for the management of anaemia of end stage kidney disease (ESKD).
Hypothesis:
ESA resistance is associated with adverse vascular outcomes and poor quality of life in ESKD.
The CEDOSE trial will evaluate the benefits and harms of two fixed ESA doses and explore the role of two treatment strategies, one based on a low and one based on a high ESA dose.
Interventions and Comparison:
Patients will be randomized 1:1 to 4000 IU/week iv. versus 18000 IU/week iv. of epoetin alfa, beta or any other epoetin in equivalent doses.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Giovanni FM Strippoli, MD | +39 0872 570 ext 356 | strippoli@negrisud.it |
Italy | |
"A. Perrino" Hospital | |
Brindisi, Italy, 72100 |
Study Chair: | Giovanni FM Strippoli, MD | Consorzio Mario Negri Sud |
Responsible Party: | Consorzio Mario Negri Sud ( Dr. Giovanni Strippoli ) |
Study ID Numbers: | FARM6X822T, 2008-006014-20 |
Study First Received: | January 21, 2009 |
Last Updated: | January 21, 2009 |
ClinicalTrials.gov Identifier: | NCT00827021 History of Changes |
Health Authority: | Italy: National Monitoring Centre for Clinical Trials - Ministry of Health |
Epoetin Alfa Renal Insufficiency Urologic Diseases Hematinics Renal Insufficiency, Chronic |
Kidney Failure, Chronic Quality of Life Kidney Diseases Kidney Failure |
Epoetin Alfa Renal Insufficiency Urologic Diseases Hematinics Renal Insufficiency, Chronic Therapeutic Uses |
Hematologic Agents Kidney Failure, Chronic Kidney Diseases Pharmacologic Actions Kidney Failure |