Assesment of a Predictive Model Dosage of EPO in Hemodialysis Patients

NCT ID: NCT02337335

Last Updated: 2015-01-13

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 268 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2015-04-30

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.

Conditions

Anemia

Study Design

• Observational Model Type: CASE_CROSSOVER
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Francesc Moreso

UNKNOWN

Sponsor Role: collaborator

NephroCare Spain

INDUSTRY

Sponsor Role: lead

Responsible Party

Rosa Ramos

Medical Department Management

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

NephroCare Spain

Tres Cantos, Madrid, Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Rosa Ramos, MD, Ph D

Role: CONTACT

rosa.ramos@fmc-ag.com

+34 630909907

Facility Contacts

Rosa Ramos, MD, Ph

Role: primary

rosa.ramos@fmc-ag.com

913276650 ext. 134

Javier Varas

Role: backup

javier.varas@fmc-ag.com

913276650 ext. 233

Other Identifiers

NCSRR01

Identifier Type: -

Identifier Source: org_study_id