AnemiaNCT02337335
Assesment of a Predictive Model Dosage of EPO in Hemodialysis Patients
An observational study of Anemia, run by NephroCare Spain at 1 site in Spain.
Trial summary
Assesment of a predictive model of anemia management: Dosage of erythropoietin (EPO) and Iron adminsitration in hemodialysis patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anemia
- How many people
- 268 participants
- Where
- 1 siteSpain
- Study dates
- Nov 2014to Apr 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients on hemodialysis
Who may be able to join
- > 18 Years
- > 3 Months on HD / OLHDF
- Treated with ESAs( epoBeta ) from> 3 Months
Who cannot join
- Chronic inflammatory diseases
- Liver Cirrhosis
- Active Neoplasms
- Immunosuppression or other antiinflammatory medication
- Patients who do not require treatment with ESAs
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
NephroCare Spain
Tres Cantos, Madrid, 28760
Rosa Ramos, MD, Ph, 913276650 ext. 134, rosa.ramos@fmc-ag.com
Javier Varas, 913276650 ext. 233, javier.varas@fmc-ag.com
About this study
Assesment of a predictive model of anemia management: Dosage of erythropoietin (EPO) and Iron adminsitration in hemodialysis patients.
Read the 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
- Keywords
- Hemodialyisis, Predictive Model, ESAs, patients
- Medical subject headings
- Anemia
What is being measured
The primary outcome is the main question the study is designed to answer.
Erythropoietin stimulating agents dosage
u/kg/week
Measured: at six months
Intravenous Iron dosage
mg/mont
Measured: at six months
Secondary outcomes (2)
anemia parameters
ferritin (µg/l), ESA resistance index, transferrin index (%)
Measured: at six months
Cardiovascular events
hospitalisation (days of hospitalisation), death and death cause,
Measured: at six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2015 (estimated)
- Study startNov 2014
- Primary completionDec 2014
- Study completionApr 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 268 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NephroCare Spain
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Francesc Moreso
- Responsible party
- Principal investigator, Rosa Ramos, NephroCare Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02337335
- Sponsor's protocol ID
- NCSRR01
- Status last verified
- Jan 2015
- First submitted
- 3 Nov 2014
- Last updated
- 13 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assesment of a Predictive Model Dosage of EPO in Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT02337335
- Acronym / sponsor ID
- NCSRR01
- Conditions
- Anemia
- Keywords
- Hemodialyisis, Predictive Model, ESAs, patients
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 268 participants (estimated)
- Lead sponsor
- NephroCare SpainIndustry (pharma, biotech, devices)
- Collaborators
- Francesc Moreso
- Study start
- Nov 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Apr 2015 (estimated)
- First posted
- 13 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case crossover
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients on hemodialysis
Key inclusion criteria (3 listed)
- > 18 Years
- > 3 Months on HD / OLHDF
- Treated with ESAs( epoBeta ) from> 3 Months
Key exclusion criteria (5 listed)
- Chronic inflammatory diseases
- Liver Cirrhosis
- Active Neoplasms
- Immunosuppression or other antiinflammatory medication
- Patients who do not require treatment with ESAs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Erythropoietin stimulating agents dosage
Time frame: at six months
u/kg/week
Intravenous Iron dosage
Time frame: at six months
mg/mont
2 secondary outcomes
anemia parameters
Time frame: at six months
Cardiovascular events
Time frame: at six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anemia, run by NephroCare Spain at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rosa Ramos, MD, Ph D (+34 630909907, rosa.ramos@fmc-ag.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Erythropoietin stimulating agents dosage (time frame: at six months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2015.