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The Clinical Evaluation of the Dose of Erythropoietins Trial

NCT00827021 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 656

Last updated 2016-07-19

No results posted yet for this study

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).

Conditions

  • Kidney Failure, Chronic

Interventions

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

Sponsors & Collaborators

  • Giovanni FM Strippoli, MD

    lead OTHER

Principal Investigators

  • Giovanni FM Strippoli, MD · Fondazione Mario Negri Sud

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2014-07-31
Completion
2014-07-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00827021 on ClinicalTrials.gov