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Assesment of a Predictive Model Dosage of EPO in Hemodialysis Patients

Assesment of a Predictive Model Dosage of EPO in Hemodialysis Patients

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02337335
Enrollment
268
Registered
2015-01-13
Start date
2014-11-30
Completion date
2015-04-30
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anemia

Keywords

Hemodialyisis, Predictive Model, ESAs, patients

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.

Interventions

None listed

Sponsors

Francesc Moreso
CollaboratorUNKNOWN
NephroCare Spain
Lead SponsorINDUSTRY

Study design

Observational model
CASE_CROSSOVER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Erythropoietin stimulating agents dosageat six monthsu/kg/week
Intravenous Iron dosageat six monthsmg/mont

Secondary

MeasureTime frameDescription
anemia parametersat six monthsferritin (µg/l), ESA resistance index, transferrin index (%)
Cardiovascular eventsat six monthshospitalisation (days of hospitalisation), death and death cause,

Countries

Spain

Contacts

Primary ContactRosa Ramos, MD, Ph D
rosa.ramos@fmc-ag.com+34 630909907

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026