Assesment of a Predictive Model Dosage of EPO in Hemodialysis Patients

• Conditions: Anemia

• Registration Number: NCT02337335
• Lead Sponsor: NephroCare Spain

Brief Summary

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

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 Timeline

• Study Start: 2014-11
• Study First Submitted: 2014-11-03
• Primary Completion: 2014-12
• Status Verified: 2015-01
• Study First Submitted QC: 2015-01-08
• Last Update Submitted: 2015-01-08
• Study First Posted: 2015-01-13
• Last Update Posted: 2015-01-13
• Study Completion: 2015-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 268

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Intravenous Iron dosage	at six months	mg/mont
Erythropoietin stimulating agents dosage	at six months	u/kg/week

Secondary Outcome Measures

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

Trial Locations

Locations (1)

NephroCare Spain; 🇪🇸 Tres Cantos, Madrid, Spain