Trial Outcomes & Findings for Intelligent Control Approach to Anemia Management (NCT NCT00572533)
NCT ID: NCT00572533
Last Updated: 2017-12-13
Results Overview
Percentage of Hemoglobin concentrations measured (once per month) between 10 and 12 g/dL.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
62 participants
Primary outcome timeframe
12 months
Results posted on
2017-12-13
Participant Flow
Participant milestones
| Measure |
Control
ESA Dose Adjustment per standard Anemia Management Protocol
|
Treatment
ESA Dose Adjustment per "Smart Anemia Manager" Algorithm
|
|---|---|---|
|
Overall Study
STARTED
|
31
|
31
|
|
Overall Study
COMPLETED
|
24
|
28
|
|
Overall Study
NOT COMPLETED
|
7
|
3
|
Reasons for withdrawal
| Measure |
Control
ESA Dose Adjustment per standard Anemia Management Protocol
|
Treatment
ESA Dose Adjustment per "Smart Anemia Manager" Algorithm
|
|---|---|---|
|
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
Intelligent Control Approach to Anemia Management
Baseline characteristics by cohort
| Measure |
Control
n=31 Participants
ESA Dose Adjustment per standard Anemia Management Protocol
|
Treatment
n=31 Participants
ESA Dose Adjustment per "Smart Anemia Manager" Algorithm
|
Total
n=62 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
24 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Age, Continuous
|
57 years
STANDARD_DEVIATION 10 • n=5 Participants
|
57 years
STANDARD_DEVIATION 9 • n=7 Participants
|
57 years
STANDARD_DEVIATION 9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
20 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
31 participants
n=5 Participants
|
31 participants
n=7 Participants
|
62 participants
n=5 Participants
|
|
Diabetes
Diabetes
|
17 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Diabetes
No Diabetes
|
14 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Congestive Heart Failure (CHF)
CHF
|
6 Subjects
n=5 Participants
|
8 Subjects
n=7 Participants
|
14 Subjects
n=5 Participants
|
|
Congestive Heart Failure (CHF)
No CHF
|
25 Subjects
n=5 Participants
|
23 Subjects
n=7 Participants
|
48 Subjects
n=5 Participants
|
|
Vascular Access Type
Fistula
|
20 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Vascular Access Type
Catheter
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Vascular Access Type
Graft
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Hemoglobin (g/dL)
|
11.2 g/dL
STANDARD_DEVIATION 1.4 • n=5 Participants
|
11.3 g/dL
STANDARD_DEVIATION 1.0 • n=7 Participants
|
11.3 g/dL
STANDARD_DEVIATION 1.2 • n=5 Participants
|
|
ESA dose
|
4,645 IU/week/subject
STANDARD_DEVIATION 7,468 • n=5 Participants
|
5,290 IU/week/subject
STANDARD_DEVIATION 7,751 • n=7 Participants
|
4,968 IU/week/subject
STANDARD_DEVIATION 7,555 • n=5 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Intent-To-Treat Analysis, Missing Data Excluded
Percentage of Hemoglobin concentrations measured (once per month) between 10 and 12 g/dL.
Outcome measures
| Measure |
Control
n=31 Participants
ESA Dose Adjustment per standard Anemia Management Protocol
|
Treatment
n=31 Participants
ESA Dose Adjustment per "Smart Anemia Manager" Algorithm
|
|---|---|---|
|
Percent Hb 10-12 g/dL
|
61.9 Percent
|
72.5 Percent
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Intent-To-Treat Analysis, Missing Data Excluded
Percentage of Hemoglobin concentrations measured (once per month) less than 10 g/dL.
Outcome measures
| Measure |
Control
n=31 Participants
ESA Dose Adjustment per standard Anemia Management Protocol
|
Treatment
n=31 Participants
ESA Dose Adjustment per "Smart Anemia Manager" Algorithm
|
|---|---|---|
|
Percent Hb < 10 g/dL
|
24.7 Percent
|
11.8 Percent
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Intent-To-Treat, Missed Data Excluded
Percentage of Hemoglobin concentrations measured (once per month) greater than 12 g/dL.
Outcome measures
| Measure |
Control
n=31 Participants
ESA Dose Adjustment per standard Anemia Management Protocol
|
Treatment
n=31 Participants
ESA Dose Adjustment per "Smart Anemia Manager" Algorithm
|
|---|---|---|
|
Percent Hb > 12 g/dL
|
13.4 Percent
|
15.7 Percent
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Intent-To-Treat Analysis, Missing Data Excluded
Mean Hemoglobin concentration over follow-up period
Outcome measures
| Measure |
Control
n=31 Participants
ESA Dose Adjustment per standard Anemia Management Protocol
|
Treatment
n=31 Participants
ESA Dose Adjustment per "Smart Anemia Manager" Algorithm
|
|---|---|---|
|
Mean Hb
|
10.7 g/dL
Standard Deviation 1.5
|
11.0 g/dL
Standard Deviation 1.2
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Intent-to-Treat Analysis, Missing Data Excluded
Mean ESA dose per patient-week. ESA used: Epoetin Alfa (IV)
Outcome measures
| Measure |
Control
n=31 Participants
ESA Dose Adjustment per standard Anemia Management Protocol
|
Treatment
n=31 Participants
ESA Dose Adjustment per "Smart Anemia Manager" Algorithm
|
|---|---|---|
|
ESA Dose
|
3,033 IU
Standard Deviation 3,592
|
3,704 IU
Standard Deviation 5,221
|
POST_HOC outcome
Timeframe: 12 monthsPopulation: Intent-To-Treat, Missing Data Excluded
Number of Transfusion Events
Outcome measures
| Measure |
Control
n=31 Participants
ESA Dose Adjustment per standard Anemia Management Protocol
|
Treatment
n=31 Participants
ESA Dose Adjustment per "Smart Anemia Manager" Algorithm
|
|---|---|---|
|
Transfusion Events
|
13 Events
|
6 Events
|
POST_HOC outcome
Timeframe: 12 monthsPopulation: Intent-To-Treat, Missing Data Excluded
Number of Subjects receiving Transfusion
Outcome measures
| Measure |
Control
n=31 Participants
ESA Dose Adjustment per standard Anemia Management Protocol
|
Treatment
n=31 Participants
ESA Dose Adjustment per "Smart Anemia Manager" Algorithm
|
|---|---|---|
|
Subjects Receiving Transfusion
|
8 Participants
|
5 Participants
|
POST_HOC outcome
Timeframe: 12 monthsPopulation: Intent-To-Treat, Missing Data Excluded
Total number of RBC units transfused
Outcome measures
| Measure |
Control
n=31 Participants
ESA Dose Adjustment per standard Anemia Management Protocol
|
Treatment
n=31 Participants
ESA Dose Adjustment per "Smart Anemia Manager" Algorithm
|
|---|---|---|
|
RBC Units Transfused
|
31 RBC Units
|
21 RBC Units
|
Adverse Events
Control
Serious events: 19 serious events
Other events: 17 other events
Deaths: 0 deaths
Treatment
Serious events: 18 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Control
n=31 participants at risk
ESA Dose Adjustment per standard Anemia Management Protocol
|
Treatment
n=31 participants at risk
ESA Dose Adjustment per "Smart Anemia Manager" Algorithm
|
|---|---|---|
|
General disorders
Composite Safety Event (ACM, MI, CVA, CHF)
|
19.4%
6/31 • Number of events 10 • 04/01/2011 - 03/31/2012
|
32.3%
10/31 • Number of events 11 • 04/01/2011 - 03/31/2012
|
|
General disorders
Hospitalization
|
58.1%
18/31 • Number of events 39 • 04/01/2011 - 03/31/2012
|
58.1%
18/31 • Number of events 41 • 04/01/2011 - 03/31/2012
|
Other adverse events
| Measure |
Control
n=31 participants at risk
ESA Dose Adjustment per standard Anemia Management Protocol
|
Treatment
n=31 participants at risk
ESA Dose Adjustment per "Smart Anemia Manager" Algorithm
|
|---|---|---|
|
Surgical and medical procedures
Vascular Access Event
|
54.8%
17/31 • Number of events 27 • 04/01/2011 - 03/31/2012
|
51.6%
16/31 • Number of events 38 • 04/01/2011 - 03/31/2012
|
|
General disorders
Infection
|
16.1%
5/31 • Number of events 8 • 04/01/2011 - 03/31/2012
|
19.4%
6/31 • Number of events 10 • 04/01/2011 - 03/31/2012
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place