Assesment of a Predictive Model Dosage of EPO in Hemodialysis Patients

Assesment of a predictive model of anemia management: Dosage of erythropoietin (EPO) and Iron adminsitration in hemodialysis patients.

Study Overview

• Status: Unknown
• Conditions: Anemia

Detailed Description

Anemia in patients on hemodialysis (HD ) is common and although usually responds well to treatment with Erythropoiesis Stimulating Agents (ESAs ) , this dosage , based on different clinical protocols , often ignores the high variability inter- and intra -individual in patient response . The result leads to swings in the objective by different dosage range that is associated with multiple risks and side effects. There are artificial intelligence-based optimization methods that predict treatment with ESAs in maintaining patient hemoglobin target range . So far the model has been validated for the long half-life of EPO ( darbepoetin ) with promising results.

HYPOTHESIS: Maintaining patients in Hb levels ESAs range using short half-life , avoid the one hand , the need for transfusions and, secondly , the levels exceeding the upper range ( overshooting ), preventing the onset of a increased cardiovascular risk events.

RELEVANCE:The results allow us to validate the model with short half-life ESAs optimizing the management of anemia and improving comorbidity associated with overdosage.

SUMMARY:

Prospective observational study of paired data. Data obtained from the data base Euclid . Data will be collected by clinical teams according to standard clinical practice. Informed at the time of admission to the clinic consent will be obtained . All patient data including to november 15th 2014 and who have completed the study period to 30 april 2015. The results will be compared with those prior to the patient's inclusion in the study were processed.

To detect a difference of 10% in the percentage of patients in the hemoglobin target range after intervention (from 70% to 80%) we will need a minimum sample size of 268 patients assuming an alpha error of 0.05, a beta error of 0.2 and a correlation between both observations of 0.1.

• Study Type: Observational
• Enrollment (Anticipated): 268

Contacts and Locations

• Study Contact: Name: Rosa Ramos, MD, Ph D; Phone Number: +34 630909907; Email: rosa.ramos@fmc-ag.com

Study Locations

• Spain
  • Madrid
    • Tres Cantos, Madrid, Spain, 28760
      • Recruiting
      • NephroCare Spain
      • Contact: Rosa Ramos, MD, Ph; Phone Number: 134 913276650; Email: rosa.ramos@fmc-ag.com
      • Contact: Javier Varas; Phone Number: 233 913276650; Email: javier.varas@fmc-ag.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients on hemodialysis

Description

Inclusion Criteria:

• > 18 Years
• > 3 Months on HD / OLHDF
• Treated with ESAs( epoBeta ) from> 3 Months

Exclusion Criteria:

• Chronic inflammatory diseases
• Liver Cirrhosis
• Active Neoplasms
• Immunosuppression or other antiinflammatory medication
• Patients who do not require treatment with ESAs

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Erythropoietin stimulating agents dosage	u/kg/week	at six months
Intravenous Iron dosage	mg/mont	at six months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
anemia parameters	ferritin (µg/l), ESA resistance index, transferrin index (%)	at six months
Cardiovascular events	hospitalisation (days of hospitalisation), death and death cause,	at six months

Collaborators and Investigators

• Sponsor: NephroCare Spain
• Collaborators: Francesc Moreso

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Actual): December 1, 2014
• Study Completion (Anticipated): April 1, 2015

Study Registration Dates

• First Submitted: November 3, 2014
• First Submitted That Met QC Criteria: January 8, 2015
• First Posted (Estimate): January 13, 2015

Study Record Updates

• Last Update Posted (Estimate): January 13, 2015
• Last Update Submitted That Met QC Criteria: January 8, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Keywords: patients; Predictive Model; Hemodialyisis; ESAs
• Other Study ID Numbers: NCSRR01