NCT00827021

The Clinical Evaluation of the Dose of Erythropoietins Trial

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 656 (actual)
• Sponsor: Giovanni FM Strippoli, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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 1. the evaluation of biochemical markers to determine the efficacy of individual prediction of ESAs therapy 2. to determine the benefits and harms of different ESA doses therapeutic strategy for the management of anaemia of end stage kidney disease (ESKD).

Detailed description

Phase III pragmatic, randomized-controlled trial comparing different doses of ESAs in patients with renal anaemia. Study Sample: Total of 900 participants from 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 biochemical markers to determine the efficacy of individual prediction of ESAs therapy; moreover it 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.

Conditions

• Kidney Failure, Chronic

Interventions

Type	Name	Description
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
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

Timeline

• Start date: 2009-07-01
• Primary completion: 2014-07-01
• Completion: 2014-07-01
• First posted: 2009-01-22
• Last updated: 2016-07-19

Locations

41 sites across 1 country: Italy