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| ID | Type | Description | Link |
|---|---|---|---|
| K25DK072085 | U.S. NIH Grant/Contract | View source | |
| 1K25DK072085-01A2 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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First clinical evaluation of "Smart Anemia Manager" algorithm.
The purpose of this single-center study is to test whether "Smart Anemia Manager" algorithm improves Hemoglobin stability compared to standard Anemia Management Protocol. Study site: Kidney Disease Program dialysis facility, University of Louisville, Louisville, KY.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Active Comparator | ESA Dose Adjustment per standard Anemia Management Protocol |
|
| Treatment | Experimental | ESA Dose Adjustment per "Smart Anemia Manager" Algorithm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ESA Dose Adjustment per standard Anemia Management Protocol | Other | Amount of ESA dose adjustment in Units per week guided by standard Anemia Management Protocol in use at the facility |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Hb 10-12 g/dL | Percentage of Hemoglobin concentrations measured (once per month) between 10 and 12 g/dL. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Hb < 10 g/dL | Percentage of Hemoglobin concentrations measured (once per month) less than 10 g/dL. | 12 months |
| Percent Hb > 12 g/dL | Percentage of Hemoglobin concentrations measured (once per month) greater than 12 g/dL. |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adam E Gaweda, Ph.D. | University of Louisville | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Louisville Kidney Disease Program | Louisville | Kentucky | 40202 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control | ESA Dose Adjustment per standard Anemia Management Protocol |
| FG001 | Treatment | ESA Dose Adjustment per "Smart Anemia Manager" Algorithm |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control | ESA Dose Adjustment per standard Anemia Management Protocol |
| BG001 | Treatment | ESA Dose Adjustment per "Smart Anemia Manager" Algorithm |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent Hb 10-12 g/dL | Percentage of Hemoglobin concentrations measured (once per month) between 10 and 12 g/dL. | Intent-To-Treat Analysis, Missing Data Excluded | Posted | Number | Percent | 12 months |
|
|
04/01/2011 - 03/31/2012
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control | ESA Dose Adjustment per standard Anemia Management Protocol |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Composite Safety Event (ACM, MI, CVA, CHF) | General disorders | Systematic Assessment | All-Cause Mortality, Myocardial Infarction, Cerebrovascular Accident, Congestive Heart Failure |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vascular Access Event | Surgical and medical procedures | Systematic Assessment |
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Adam E Gaweda | University of Louisville | 502-852-0766 | adam.gaweda@louisville.edu |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| ID | Term |
|---|---|
| D000249 | Adenosine Monophosphate |
| ID | Term |
|---|---|
| D000227 | Adenine Nucleotides |
| D011685 | Purine Nucleotides |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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|
| ESA Dose Adjustment per "Smart Anemia Manager" Algorithm | Other | Amount of ESA dose adjustment in Units per week individualized to subject's dose-response profile guided by "Smart Anemia Manager" algorithm |
|
|
| 12 months |
| Mean Hb | Mean Hemoglobin concentration over follow-up period | 12 months |
| ESA Dose | Mean ESA dose per patient-week. ESA used: Epoetin Alfa (IV) | 12 months |
| Social Issues |
|
| Transfer out of Facility |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | Participants |
|
| Region of Enrollment | Number | participants |
|
| Diabetes | Number of subjects with diagnosed diabetes | Number | Participants |
|
| Congestive Heart Failure (CHF) | Number of subjects with diagnosed CHF | Number | Subjects |
|
| Vascular Access Type | Number of patients with specific vascular access type | Number | Participants |
|
| Hemoglobin (g/dL) | Hemoglobin concentration in March 2011 | Mean | Standard Deviation | g/dL |
|
| ESA dose | ESA dose across group in March 2011 | Mean | Standard Deviation | IU/week/subject |
|
| Counts |
|---|
| Participants |
|
|
| Secondary | Percent Hb < 10 g/dL | Percentage of Hemoglobin concentrations measured (once per month) less than 10 g/dL. | Intent-To-Treat Analysis, Missing Data Excluded | Posted | Number | Percent | 12 months |
|
|
|
| Post-Hoc | Transfusion Events | Number of Transfusion Events | Intent-To-Treat, Missing Data Excluded | Posted | Number | Events | 12 months |
|
|
|
| Secondary | Percent Hb > 12 g/dL | Percentage of Hemoglobin concentrations measured (once per month) greater than 12 g/dL. | Intent-To-Treat, Missed Data Excluded | Posted | Number | Percent | 12 months |
|
|
|
| Secondary | Mean Hb | Mean Hemoglobin concentration over follow-up period | Intent-To-Treat Analysis, Missing Data Excluded | Posted | Mean | Standard Deviation | g/dL | 12 months |
|
|
|
| Secondary | ESA Dose | Mean ESA dose per patient-week. ESA used: Epoetin Alfa (IV) | Intent-to-Treat Analysis, Missing Data Excluded | Posted | Mean | Standard Deviation | IU | 12 months |
|
|
|
| Post-Hoc | Subjects Receiving Transfusion | Number of Subjects receiving Transfusion | Intent-To-Treat, Missing Data Excluded | Posted | Number | Participants | 12 months |
|
|
|
| Post-Hoc | RBC Units Transfused | Total number of RBC units transfused | Intent-To-Treat, Missing Data Excluded | Posted | Number | RBC Units | 12 months |
|
|
|
| 19 |
| 31 |
| 17 |
| 31 |
| EG001 | Treatment | ESA Dose Adjustment per "Smart Anemia Manager" Algorithm | 18 | 31 | 16 | 31 |
|
| Hospitalization | General disorders | Systematic Assessment | All-Cause Hospitalization (includes hospitalization due to Composite Safety Event) |
|
| Infection | General disorders | Systematic Assessment |
|
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| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D009711 | Nucleotides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012265 | Ribonucleotides |