Assesment of a Predictive Model Dosage of EPO in Hemodialysis Patients

Anemia Clinical Trial

Official title:

Assesment of a Predictive Model Dosage of EPO in Hemodialysis Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02337335
• Other study ID #: NCSRR01
• Status: Recruiting
• Phase: N/A
• First received: November 3, 2014
• Last updated: January 8, 2015
• Start date: November 2014
• Est. completion date: April 2015

Study information

• Verified date: January 2015
• Source: NephroCare Spain
• Contact: Rosa Ramos, MD, Ph D
• Phone: +34 630909907
• Email: rosa.ramos[@]fmc-ag.com
• Is FDA regulated: No
• Health authority: Spain: Departament de Salut de la Generalitat de Catalunya
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 268
• Est. completion date: April 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case-Crossover, Time Perspective: Prospective

Related Conditions & MeSH terms

• Anemia

Locations

Country	Name	City	State
Spain	NephroCare Spain	Tres Cantos	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
NephroCare Spain	Francesc Moreso

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Erythropoietin stimulating agents dosage	u/kg/week	at six months	No
Primary	Intravenous Iron dosage	mg/mont	at six months	No
Secondary	anemia parameters	ferritin (µg/l), ESA resistance index, transferrin index (%)	at six months	No
Secondary	Cardiovascular events	hospitalisation (days of hospitalisation), death and death cause,	at six months	No