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NCT Number: NCT00827021

The Clinical Evaluation of the Dose of Erythropoietins Trial

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).

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Key information

Conditions

Kidney Failure, Chronic Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Ospedale Beato Angelo, Acri, Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age > = 18,
  • End stage kidney disease and anemia
  • Treatment with hemodialysis for renal replacement therapy
  • no contraindications to erythropoietin stimulating agents (ESAs) or already treated with ESAs

Exclusion criteria

  • Patients with Hb levels > 10 g/dl without ESAs

Treatment and study plan

Erythropoiesis Stimulating Agents (ESAs): epoetin alfa, beta or any other epoetin in equivalent dose.

Drug

4000 IU/week I.V. Until the end of the trial

Primary outcomes

  1. TSAT (transferrin saturation), serum albumin, serum ferritin, serum transferrin, serum C reactive protein

    Time frame: after randomization at month 1, 2, 3, 6, 12

Secondary outcomes

  1. Cardiovascular mortality

    Time frame: after randomization at month 1, 2, 3, 6, 12

  2. sudden death

    Time frame: after randomization at month 1, 2, 3, 6, 12

  3. Stroke

    Time frame: after randomization at month 1, 2, 3, 6, 12

  4. myocardial infarction

    Time frame: after randomization at month 1, 2, 3, 6, 12

  5. hospitalizations due to acute coronary syndrome, transitory ischemic attacks, not planned coronary revascularization, peripheric revascularization.

    Time frame: after randomization at month 1, 2, 3, 6, 12

  6. Thrombosis of the cardiovascular access

    Time frame: after randomization at month 1, 2, 3, 6, 12

  7. Seizures

    Time frame: after randomization at month 1, 2, 3, 6, 12

  8. Hypertensive events

    Time frame: after randomization at month 1, 2, 3, 6, 12

  9. Quality of life (QoL)

    Time frame: at randomization and at 6 and 12 months

  10. composite of all-cause mortality, non fatal myocardial infarction and stroke, hospitalizations due to acute coronary syndrome, transitory ischaemic attacks, not planned coronary revascularization procedures, peripheric revascularization procedures.

    Time frame: after randomization at month 1, 2, 3, 6, 12

Sponsors and collaborators

Lead sponsor

Giovanni FM Strippoli, MD

Other

Registry information

Official study 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

Acronym: CEDOSE

Important dates

Study start
2009
Primary completion
2014
Study completion
2014
First posted
Jan 22, 2009
Registry last updated
Jul 19, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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