Anemia of End Stage Renal DiseaseNCT01719146
Prospective Observational Study of Erythropoietin-Iron Interaction in Anemia of Renal Disease
An observational study of Anemia of End Stage Renal Disease, run by University of Louisville at 3 sites in United States.
Trial summary
The purpose of this study is to prospectively collect data on doses of Erythropoietic Stimulating Agents (ESA) and Intravenous Iron, and the markers of erythropoietic activity and iron status. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anemia of End Stage Renal Disease
- What is being tested?
- Specimen collection
- How many people
- 134 participants
- Where
- 3 sitesUnited States
- Study dates
- Jan 2013to 5 Jun 2021
- 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: End Stage Renal Disease Patients undergoing hemodialysis treatments at: 1. University Kidney Center, Louisville, KY 2. Duke University, Durham, NC 3. WNERTA, Springfield, MA
Who may be able to join
- receiving or expected to receive ESA
Who cannot join
- life expectancy less than 12 months
- frequent (once or more per month w/in last 6 months) uncontrolled blood loss
- frequent (once or more per month w/in last 6 months) hospitalization
- frequent (once or more per month w/in last 6 months) access complications
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Duke University
Durham, North Carolina, 27710
University of Louisville, University Kidney Center
Louisville, Kentucky, 40202
Western New England Renal and Transplant Associates
Springfield, Massachusetts, 01107
About this study
Official title: Computational Approach to Personalized Anemia Management
The purpose of this study is to prospectively collect data on doses of Erythropoietic Stimulating Agents (ESA) and Intravenous Iron, and the markers of erythropoietic activity and iron status. These data will be used to derive mathematical models which will subsequently guide dosing of both agents, such that a desired therapeutic outcome is achieved in every patient, while minimizing patient exposure to both agents.
Read the detailed description
Data will be collected from 120 subjects undergoing hemodialysis treatment at 3 clinical sites across United States (40 per site).5.5 mL blood specimen will be drawn during midweek treatment (Wed/Thu) to measure:
Hemoglobin Concentration Hematocrit Red Blood Cell Count Platelet Count Reticulocyte Percentage Reticulocyte Hemoglobin Mean Cellular Hemoglobin Mean Cellular Hemoglobin Concentration Mean Cell Volume Red Cell Volume Distribution Width Mean Platelet Volume Serum Iron Serum Ferritin Transferrin Saturation Hepcidin Soluble Transferrin Receptor
Weekly ESA and Iron dose delivered will also be recorded.
From these data:
- a mathematical model will be established to find biomarkers most descriptive with respect to erythropoiesis-iron synergy,
- a mathematical model will be established to correlate iron dose with iron markers.
- Conditions
- Anemia of End Stage Renal Disease
- Being tested
- Specimen collection
- Keywords
- Anemia, Chronic Kidney Disease, Erythropoiesis Stimulating Agents, Erythropoietin, Iron, Iron Deficiency
- Medical subject headings
- Anemia, Renal Insufficiency, Chronic, Iron Deficiencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Specimen collectionOther
At the beginning of each midweek hemodialysis session, a blood specimen (4 mL) will be drawn from the study subject. Out of this specimen a 1 mL serum sample will be frozen and stored. A 3 mL blood sample will be shipped overnight to WNERTA for laboratory testing.
| Study group | Role | What they receive |
|---|---|---|
| UofL Subjects | Subjects undergoing Specimen Collection at University Kidney Center, University of Louisville, Louisville, KY Receives: Other: Specimen collection | |
| Duke Subjects | Subjects undergoing Specimen Collection at Duke University, Durham, NC Receives: Other: Specimen collection | |
| WNERTA Subjects | Subject undergoing Specimen Collection at Western New England Renal and Transplant Associates, Springfield, MA Receives: Other: Specimen collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin Concentration (g/dL)
Weekly Hemoglobin Concentration
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2012 (estimated)
- Study startJan 2013
- Primary completion5 Jun 2021
- Study completion5 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anemia of End Stage Renal DiseaseStudies of the same condition, open and under way.
- More trials run by University of LouisvilleThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Louisville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adam Edward Gaweda, University of Louisville
- Investigators
- Adam E Gaweda, Ph.D., Principal investigator, University of Louisville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01719146
- Sponsor's protocol ID
- 12.0149
- Other IDs
- R01DK093832
- Status last verified
- Oct 2022
- First submitted
- 29 Oct 2012
- Last updated
- 27 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computational Approach to Personalized Anemia Management
- ClinicalTrials.gov ID
- NCT01719146
- Acronym / sponsor ID
- 12.0149
- Conditions
- Anemia of End Stage Renal Disease
- Keywords
- Anemia, Chronic Kidney Disease, Erythropoiesis Stimulating Agents, Erythropoietin, Iron, Iron Deficiency
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- University of LouisvilleUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Jan 2013
- Primary completion
- 5 Jun 2021 (actual)
- Study completion
- 5 Jun 2021 (actual)
- First posted
- 1 Nov 2012 (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.
The purpose of this study is to prospectively collect data on doses of Erythropoietic Stimulating Agents (ESA) and Intravenous Iron, and the markers of erythropoietic activity and iron status. These data will be used to derive mathematical models which will subsequently guide dosing of both agents, such that a desired therapeutic outcome is achieved in every patient, while minimizing patient exposure to both agents.
Detailed description
Data will be collected from 120 subjects undergoing hemodialysis treatment at 3 clinical sites across United States (40 per site).5.5 mL blood specimen will be drawn during midweek treatment (Wed/Thu) to measure:
Hemoglobin Concentration Hematocrit Red Blood Cell Count Platelet Count Reticulocyte Percentage Reticulocyte Hemoglobin Mean Cellular Hemoglobin Mean Cellular Hemoglobin Concentration Mean Cell Volume Red Cell Volume Distribution Width Mean Platelet Volume Serum Iron Serum Ferritin Transferrin Saturation Hepcidin Soluble Transferrin Receptor
Weekly ESA and Iron dose delivered will also be recorded.
From these data:
- a mathematical model will be established to find biomarkers most descriptive with respect to erythropoiesis-iron synergy,
- a mathematical model will be established to correlate iron dose with iron markers.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| UofL Subjects | – | Other: Specimen collectionSubjects undergoing Specimen Collection at University Kidney Center, University of Louisville, Louisville, KY |
| Duke Subjects | – | Other: Specimen collectionSubjects undergoing Specimen Collection at Duke University, Durham, NC |
| WNERTA Subjects | – | Other: Specimen collectionSubject undergoing Specimen Collection at Western New England Renal and Transplant Associates, Springfield, MA |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- End Stage Renal Disease Patients undergoing hemodialysis treatments at: 1. University Kidney Center, Louisville, KY 2. Duke University, Durham, NC 3. WNERTA, Springfield, MA
Key inclusion criteria (1 listed)
- receiving or expected to receive ESA
Key exclusion criteria (4 listed)
- life expectancy less than 12 months
- frequent (once or more per month w/in last 6 months) uncontrolled blood loss
- frequent (once or more per month w/in last 6 months) hospitalization
- frequent (once or more per month w/in last 6 months) access complications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Specimen collectionAt the beginning of each midweek hemodialysis session, a blood specimen (4 mL) will be drawn from the study subject. Out of this specimen a 1 mL serum sample will be frozen and stored. A 3 mL blood sample will be shipped overnight to WNERTA for laboratory testing. | Other | Duke Subjects, UofL Subjects, WNERTA Subjects |
Primary outcome
Hemoglobin Concentration (g/dL)
Time frame: 52 weeks
Weekly Hemoglobin Concentration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Anemia of End Stage Renal Disease
Active, not recruitingPhase 2
Management of Iron Deficiency Anemia in Hemodialysis Patients
Iron Deficiency Anemia (IDA), ESRD (End Stage Renal Disease)
Active, not recruitingPhase 3
A Study of Roxadustat to Treat Anemia in Children and Teenagers With Chronic Kidney Disease
Chronic Kidney Disease, Renal Anemia
Not yet recruitingPhase 2
Efficacy and Safety of Spironolactone in Pediatric Hemodialysis Patients With Anemia.
Anemia
Recruiting
Studies on Adsorption International Learning Initiative Global
CKD (Chronic Kidney Disease) Stage 5D, Uremia; Chronic
Not yet recruitingPhase 4
Levocarnitine for Reducing ESA Requirements in Hemodialysis Patients With Renal Anemia
Anemia, Kidney Failure
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.
Adam E Gaweda, Ph.D. principal investigator
University of Louisville
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anemia of End Stage Renal Disease, run by University of Louisville at 3 sites in United States.
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 1 inclusion and 4 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: finished, as of the sponsor's last update on 27 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemoglobin Concentration (g/dL) (time frame: 52 weeks). 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 27 Oct 2022.