End-Stage Renal Disease
Conditions
Keywords
End-Stage Renal Disease, Chronic Hemodialysis
Brief summary
First clinical evaluation of Smart Anemia Manager algorithm.
Detailed description
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.
Interventions
OTHERESA Dose Adjustment per standard Anemia Management Protocol
Amount of ESA dose adjustment in Units per week guided by standard Anemia Management Protocol in use at the facility
OTHERESA Dose Adjustment per Smart Anemia Manager Algorithm
Amount of ESA dose adjustment in Units per week individualized to subject's dose-response profile guided by Smart Anemia Manager algorithm
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of Louisville
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. ages 18 to 80, 2. receiving dialysis treatment, 3. receiving or expected to receive ESA treatment, 4. adequacy of dialysis Kt/V \>= 1.2, 5. adequate iron stores (Ferritin \> 200 ng/mL, TSat \> 20%).
Exclusion criteria
1. life expectancy less than 12 months, 2. frequent uncontrolled blood loss, 3. frequent dialyzer clotting, 4. frequent access related problems, 5. active infections, 6. severe cardiac disability, 7. coronary bypass within three months prior to the study 8. documented resistance to ESA 9. bone marrow suppression due to HIV, leukemia, or pharmacologic agents.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Hb 10-12 g/dL | 12 months | Percentage of Hemoglobin concentrations measured (once per month) between 10 and 12 g/dL. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Hb < 10 g/dL | 12 months | Percentage of Hemoglobin concentrations measured (once per month) less than 10 g/dL. |
| Percent Hb > 12 g/dL | 12 months | Percentage of Hemoglobin concentrations measured (once per month) greater than 12 g/dL. |
| Mean Hb | 12 months | Mean Hemoglobin concentration over follow-up period |
| ESA Dose | 12 months | Mean ESA dose per patient-week. ESA used: Epoetin Alfa (IV) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control ESA Dose Adjustment per standard Anemia Management Protocol | 31 |
| Treatment ESA Dose Adjustment per Smart Anemia Manager Algorithm | 31 |
| Total | 62 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 4 | 1 |
| Overall Study | Received Kidney Transplant | 2 | 1 |
| Overall Study | Social Issues | 1 | 0 |
| Overall Study | Transfer out of Facility | 0 | 1 |
Baseline characteristics
| Characteristic | Control | Treatment | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 7 Participants | 4 Participants | 11 Participants |
| Age, Categorical Between 18 and 65 years | 24 Participants | 27 Participants | 51 Participants |
| Age, Continuous | 57 years STANDARD_DEVIATION 10 | 57 years STANDARD_DEVIATION 9 | 57 years STANDARD_DEVIATION 9 |
| Congestive Heart Failure (CHF) CHF | 6 Subjects | 8 Subjects | 14 Subjects |
| Congestive Heart Failure (CHF) No CHF | 25 Subjects | 23 Subjects | 48 Subjects |
| Diabetes Diabetes | 17 Participants | 18 Participants | 35 Participants |
| Diabetes No Diabetes | 14 Participants | 13 Participants | 27 Participants |
| ESA dose | 4,645 IU/week/subject | 5,290 IU/week/subject | 4,968 IU/week/subject |
| Hemoglobin (g/dL) | 11.2 g/dL STANDARD_DEVIATION 1.4 | 11.3 g/dL STANDARD_DEVIATION 1 | 11.3 g/dL STANDARD_DEVIATION 1.2 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Black or African American | 20 Participants | 21 Participants | 41 Participants |
| Race/Ethnicity, Customized More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized White | 11 Participants | 10 Participants | 21 Participants |
| Region of Enrollment United States | 31 participants | 31 participants | 62 participants |
| Sex: Female, Male Female | 9 Participants | 11 Participants | 20 Participants |
| Sex: Female, Male Male | 22 Participants | 20 Participants | 42 Participants |
| Vascular Access Type Catheter | 6 Participants | 3 Participants | 9 Participants |
| Vascular Access Type Fistula | 20 Participants | 21 Participants | 41 Participants |
| Vascular Access Type Graft | 5 Participants | 7 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 17 / 31 | 16 / 31 |
| serious Total, serious adverse events | 19 / 31 | 18 / 31 |
Outcome results
Primary
Percent Hb 10-12 g/dL
Percentage of Hemoglobin concentrations measured (once per month) between 10 and 12 g/dL.
Time frame: 12 months
Population: Intent-To-Treat Analysis, Missing Data Excluded
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control | Percent Hb 10-12 g/dL | 61.9 Percent |
| Treatment | Percent Hb 10-12 g/dL | 72.5 Percent |
Secondary
ESA Dose
Mean ESA dose per patient-week. ESA used: Epoetin Alfa (IV)
Time frame: 12 months
Population: Intent-to-Treat Analysis, Missing Data Excluded
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Control | ESA Dose | 3,033 IU |
| Treatment | ESA Dose | 3,704 IU |
Secondary
Mean Hb
Mean Hemoglobin concentration over follow-up period
Time frame: 12 months
Population: Intent-To-Treat Analysis, Missing Data Excluded
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Mean Hb | 10.7 g/dL | Standard Deviation 1.5 |
| Treatment | Mean Hb | 11.0 g/dL | Standard Deviation 1.2 |
Secondary
Percent Hb < 10 g/dL
Percentage of Hemoglobin concentrations measured (once per month) less than 10 g/dL.
Time frame: 12 months
Population: Intent-To-Treat Analysis, Missing Data Excluded
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control | Percent Hb < 10 g/dL | 24.7 Percent |
| Treatment | Percent Hb < 10 g/dL | 11.8 Percent |
Secondary
Percent Hb > 12 g/dL
Percentage of Hemoglobin concentrations measured (once per month) greater than 12 g/dL.
Time frame: 12 months
Population: Intent-To-Treat, Missed Data Excluded
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control | Percent Hb > 12 g/dL | 13.4 Percent |
| Treatment | Percent Hb > 12 g/dL | 15.7 Percent |
Post Hoc
RBC Units Transfused
Total number of RBC units transfused
Time frame: 12 months
Population: Intent-To-Treat, Missing Data Excluded
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control | RBC Units Transfused | 31 RBC Units |
| Treatment | RBC Units Transfused | 21 RBC Units |
Post Hoc
Subjects Receiving Transfusion
Number of Subjects receiving Transfusion
Time frame: 12 months
Population: Intent-To-Treat, Missing Data Excluded
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control | Subjects Receiving Transfusion | 8 Participants |
| Treatment | Subjects Receiving Transfusion | 5 Participants |
Post Hoc
Transfusion Events
Number of Transfusion Events
Time frame: 12 months
Population: Intent-To-Treat, Missing Data Excluded
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control | Transfusion Events | 13 Events |
| Treatment | Transfusion Events | 6 Events |