Clinical trial NCT02337335: Assesment of a Predictive Model Dosage of EPO in Hemodialysis Patients
Official title: Assesment of a Predictive Model Dosage of EPO in Hemodialysis Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Anemia
Keywords: Hemodialyisis
Predictive Model
ESAs
patients
Lead sponsor: NephroCare Spain
Sponsor class: INDUSTRY
Collaborators: name: Francesc Moreso
First posted: 2015-01-13
Enrollment: 268
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients on hemodialysis

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.

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

Primary outcomes:
measure: Erythropoietin stimulating agents dosage
timeFrame: at six months
measure: Intravenous Iron dosage
timeFrame: at six months
Secondary outcomes:
measure: anemia parameters
timeFrame: at six months
measure: Cardiovascular events
timeFrame: at six months
Other outcomes:
Locations:
city: Tres Cantos
country: Spain
facility: NephroCare Spain
state: Madrid
Study officials:
References: