Trial Outcomes & Findings for Study to Evaluate the Prospective Payment System (NCT NCT01717989)
NCT ID: NCT01717989
Last Updated: 2014-01-14
Results Overview
The percentage of participants within each small dialysis organization (SDO) facility with hemoglobin \< 10 g/dL over time. Percentage of participants meeting the criteria at the facility-level were calculated for each facility first and then summarized across facilities as a continuous variable, weighted by the number of participants in a facility.
Recruitment status
COMPLETED
Target enrollment
2248 participants
Primary outcome timeframe
Data were collected monthly from June 2010 until September 2012
Results posted on
2014-01-14
Participant Flow
From 16 June 2010 through 02 July 2012, 2248 participants were enrolled in the study. A total of 51 small dialysis organization facilities enrolled in the study, of these, 45 (88.2%) facilities reported completing the study, 5 (9.8%) discontinued and 1 site was unaccounted for.
Participant milestones
| Measure |
Cohort
Patients with end-stage renal disease (ESRD) treated at small dialysis organizations (SDOs).
|
|---|---|
|
Overall Study
STARTED
|
2248
|
|
Overall Study
COMPLETED
|
1182
|
|
Overall Study
NOT COMPLETED
|
1066
|
Reasons for withdrawal
| Measure |
Cohort
Patients with end-stage renal disease (ESRD) treated at small dialysis organizations (SDOs).
|
|---|---|
|
Overall Study
Ineligibility determined
|
6
|
|
Overall Study
Protocol deviation
|
6
|
|
Overall Study
Withdrawal by Subject
|
11
|
|
Overall Study
Physician Decision
|
2
|
|
Overall Study
Lost to Follow-up
|
11
|
|
Overall Study
Death
|
439
|
|
Overall Study
Protocol-specified criteria
|
551
|
|
Overall Study
Other
|
40
|
Baseline Characteristics
Study to Evaluate the Prospective Payment System
Baseline characteristics by cohort
| Measure |
Cohort
n=2248 Participants
Patients with end-stage renal disease (ESRD) treated at small dialysis organizations (SDOs).
|
|---|---|
|
Age, Continuous
|
61.1 years
STANDARD_DEVIATION 15.4 • n=93 Participants
|
|
Sex: Female, Male
Female
|
966 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
1282 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
7 participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Asian/Pacific Islander
|
258 participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
557 participants
n=93 Participants
|
|
Race/Ethnicity, Customized
White
|
1246 participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Other
|
171 participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
9 participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
646 participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Neither Hispanic or Latino
|
1602 participants
n=93 Participants
|
|
Dialysis modality at enrollment
Peritoneal
|
125 participants
n=93 Participants
|
|
Dialysis modality at enrollment
Hemodialysis (in center)
|
2107 participants
n=93 Participants
|
|
Dialysis modality at enrollment
Home hemodialysis
|
13 participants
n=93 Participants
|
|
Dialysis modality at enrollment
Missing
|
3 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Data were collected monthly from June 2010 until September 2012Population: Facilities with at least one non-missing hemoglobin record for participants included in the primary analysis set (all enrolled participants) at each time point (indicated by n).
The percentage of participants within each small dialysis organization (SDO) facility with hemoglobin \< 10 g/dL over time. Percentage of participants meeting the criteria at the facility-level were calculated for each facility first and then summarized across facilities as a continuous variable, weighted by the number of participants in a facility.
Outcome measures
| Measure |
Cohort
n=51 SDO facilities
Patients with end-stage renal disease (ESRD) treated at small dialysis organizations (SDOs).
|
Q1 2011
First quarter (Q1), 2011
|
Q2 2011
Second quarter (Q2), 2011
|
Q3 2011
Third quarter (Q3) 2011
|
Q4 2011
Fourth quarter, 2011
|
|---|---|---|---|---|---|
|
Percentage of Participants Per Facility With Hemoglobin < 10 g/dL
June 2010 (n=39)
|
11.5 percentage of participants per facility
Interval 9.4 to 13.6
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Per Facility With Hemoglobin < 10 g/dL
July 2010 (n=45)
|
11.0 percentage of participants per facility
Interval 8.3 to 13.8
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Per Facility With Hemoglobin < 10 g/dL
August 2010 (n=50)
|
13.1 percentage of participants per facility
Interval 10.9 to 15.0
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Per Facility With Hemoglobin < 10 g/dL
September 2010 (n=51)
|
12.0 percentage of participants per facility
Interval 10.0 to 13.9
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Per Facility With Hemoglobin < 10 g/dL
October 2010 (n=51)
|
12.7 percentage of participants per facility
Interval 11.1 to 14.2
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Per Facility With Hemoglobin < 10 g/dL
November 2010 (n=51)
|
13.2 percentage of participants per facility
Interval 11.3 to 15.0
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Per Facility With Hemoglobin < 10 g/dL
December 2010 (n=51)
|
14.3 percentage of participants per facility
Interval 11.9 to 16.4
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Per Facility With Hemoglobin < 10 g/dL
January 2011 (n=50)
|
13.5 percentage of participants per facility
Interval 11.6 to 15.3
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Per Facility With Hemoglobin < 10 g/dL
February 2011 (n=50)
|
18.3 percentage of participants per facility
Interval 15.6 to 21.0
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Per Facility With Hemoglobin < 10 g/dL
March 2011 (n=50)
|
16.4 percentage of participants per facility
Interval 13.7 to 19.3
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Per Facility With Hemoglobin < 10 g/dL
April 2011 (n=50)
|
16.9 percentage of participants per facility
Interval 13.8 to 19.8
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Per Facility With Hemoglobin < 10 g/dL
May 2011 (n=50)
|
15.4 percentage of participants per facility
Interval 12.7 to 18.2
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Per Facility With Hemoglobin < 10 g/dL
June 2011 (n=50)
|
16.7 percentage of participants per facility
Interval 14.0 to 19.3
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Per Facility With Hemoglobin < 10 g/dL
July 2011 (n=50)
|
14.0 percentage of participants per facility
Interval 11.9 to 16.1
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Per Facility With Hemoglobin < 10 g/dL
August 2011 (n=50)
|
15.5 percentage of participants per facility
Interval 13.2 to 17.8
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Per Facility With Hemoglobin < 10 g/dL
September 2011 (n=50)
|
19.3 percentage of participants per facility
Interval 16.6 to 22.4
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Per Facility With Hemoglobin < 10 g/dL
October 2011 (n=50)
|
21.7 percentage of participants per facility
Interval 18.7 to 25.2
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Per Facility With Hemoglobin < 10 g/dL
November 2011 (n=50)
|
22.2 percentage of participants per facility
Interval 18.8 to 25.6
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Per Facility With Hemoglobin < 10 g/dL
December 2011 (n=48)
|
21.8 percentage of participants per facility
Interval 18.7 to 25.7
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Per Facility With Hemoglobin < 10 g/dL
January 2012 (n=48)
|
22.0 percentage of participants per facility
Interval 18.2 to 26.4
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Per Facility With Hemoglobin < 10 g/dL
February 2012 (n=48)
|
19.5 percentage of participants per facility
Interval 15.9 to 23.8
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Per Facility With Hemoglobin < 10 g/dL
March 2012 (n=48)
|
23.3 percentage of participants per facility
Interval 19.7 to 27.1
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Per Facility With Hemoglobin < 10 g/dL
April 2012 (n=48)
|
24.0 percentage of participants per facility
Interval 20.8 to 27.3
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Per Facility With Hemoglobin < 10 g/dL
May 2012 (n=48)
|
25.1 percentage of participants per facility
Interval 21.1 to 28.9
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Per Facility With Hemoglobin < 10 g/dL
June 2012 (n=45)
|
24.6 percentage of participants per facility
Interval 20.7 to 29.1
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Per Facility With Hemoglobin < 10 g/dL
July 2012 (n=45)
|
23.1 percentage of participants per facility
Interval 20.2 to 26.8
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Per Facility With Hemoglobin < 10 g/dL
August 2012 (n=45)
|
22.6 percentage of participants per facility
Interval 19.2 to 26.4
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Per Facility With Hemoglobin < 10 g/dL
September 2012 (n=45)
|
22.2 percentage of participants per facility
Interval 17.8 to 26.6
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Data were collected monthly from June 2010 until September 2012Population: Facilities with at least one non-missing hemoglobin record for participants included in the primary analysis set (all enrolled participants) at each time point (indicated by n).
The percentage of participants within each small dialysis organization (SDO) facility with hemoglobin \> 12 g/dL over time. Percentage of participants meeting the criteria at the facility-level were calculated for each facility first and then summarized across facilities as a continuous variable, weighted by the number of participants in a facility.
Outcome measures
| Measure |
Cohort
n=51 SDO facilities
Patients with end-stage renal disease (ESRD) treated at small dialysis organizations (SDOs).
|
Q1 2011
First quarter (Q1), 2011
|
Q2 2011
Second quarter (Q2), 2011
|
Q3 2011
Third quarter (Q3) 2011
|
Q4 2011
Fourth quarter, 2011
|
|---|---|---|---|---|---|
|
Percentage of Participants Per Facility With Hemoglobin > 12 g/dL
July 2012 (n=45)
|
11.9 percentage of participants per facility
Interval 9.4 to 14.5
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Per Facility With Hemoglobin > 12 g/dL
August 2012 (n=45)
|
11.6 percentage of participants per facility
Interval 9.4 to 13.9
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Per Facility With Hemoglobin > 12 g/dL
September 2012 (n=45)
|
13.1 percentage of participants per facility
Interval 10.9 to 15.3
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Per Facility With Hemoglobin > 12 g/dL
June 2010 (n=39)
|
30.2 percentage of participants per facility
Interval 25.4 to 35.5
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Per Facility With Hemoglobin > 12 g/dL
July 2010 (n=45)
|
28.3 percentage of participants per facility
Interval 25.1 to 31.6
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Per Facility With Hemoglobin > 12 g/dL
August 2010 (n=50)
|
28.2 percentage of participants per facility
Interval 25.2 to 31.5
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Per Facility With Hemoglobin > 12 g/dL
September 2010 (n=51)
|
30.6 percentage of participants per facility
Interval 27.7 to 34.0
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Per Facility With Hemoglobin > 12 g/dL
October 2010 (n=51)
|
28.7 percentage of participants per facility
Interval 26.4 to 31.3
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Per Facility With Hemoglobin > 12 g/dL
November 2010 (n=51)
|
27.8 percentage of participants per facility
Interval 24.9 to 30.8
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Per Facility With Hemoglobin > 12 g/dL
December 2010 (n=51)
|
24.5 percentage of participants per facility
Interval 22.1 to 27.2
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Per Facility With Hemoglobin > 12 g/dL
January 2011 (n=50)
|
25.6 percentage of participants per facility
Interval 22.7 to 29.0
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Per Facility With Hemoglobin > 12 g/dL
February 2011 (n=50)
|
24.5 percentage of participants per facility
Interval 21.4 to 28.1
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Per Facility With Hemoglobin > 12 g/dL
March 2011 (n=50)
|
22.8 percentage of participants per facility
Interval 19.6 to 26.2
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Per Facility With Hemoglobin > 12 g/dL
April 2011 (n=50)
|
21.8 percentage of participants per facility
Interval 18.7 to 25.5
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Per Facility With Hemoglobin > 12 g/dL
May 2011 (n=50)
|
23.2 percentage of participants per facility
Interval 20.2 to 26.7
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Per Facility With Hemoglobin > 12 g/dL
June 2011 (n=50)
|
18.5 percentage of participants per facility
Interval 15.5 to 22.2
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Per Facility With Hemoglobin > 12 g/dL
July 2011 (n=50)
|
20.2 percentage of participants per facility
Interval 17.3 to 23.6
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Per Facility With Hemoglobin > 12 g/dL
August 2011 (n=50)
|
19.0 percentage of participants per facility
Interval 16.3 to 22.0
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Per Facility With Hemoglobin > 12 g/dL
September 2011 (n=50)
|
18.2 percentage of participants per facility
Interval 15.6 to 21.2
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Per Facility With Hemoglobin > 12 g/dL
October 2011 (n=50)
|
14.3 percentage of participants per facility
Interval 12.3 to 16.3
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Per Facility With Hemoglobin > 12 g/dL
November 2011 (n=50)
|
11.5 percentage of participants per facility
Interval 9.8 to 13.3
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Per Facility With Hemoglobin > 12 g/dL
December 2011 (n=48)
|
11.8 percentage of participants per facility
Interval 9.8 to 13.7
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Per Facility With Hemoglobin > 12 g/dL
January 2012 (n=48)
|
13.7 percentage of participants per facility
Interval 11.8 to 15.9
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Per Facility With Hemoglobin > 12 g/dL
February 2012 (n=48)
|
12.5 percentage of participants per facility
Interval 10.4 to 15.3
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Per Facility With Hemoglobin > 12 g/dL
March 2012 (n=48)
|
11.2 percentage of participants per facility
Interval 9.4 to 13.1
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Per Facility With Hemoglobin > 12 g/dL
April 2012 (n=48)
|
10.3 percentage of participants per facility
Interval 8.7 to 12.2
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Per Facility With Hemoglobin > 12 g/dL
May 2012 (n=48)
|
11.6 percentage of participants per facility
Interval 9.6 to 13.7
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Per Facility With Hemoglobin > 12 g/dL
June 2012 (n=45)
|
12.1 percentage of participants per facility
Interval 10.1 to 14.2
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Data were collected monthly from June 2010 until September 2012Population: Facilities with at least one non-missing URR record for participants included in the primary analysis set (all enrolled participants) at each time point (indicated by n).
The percentage of participants within each small dialysis organization (SDO) facility with a urea reduction ratio ≥ 65% over time. URR is calculated as: Baseline urea level - post-baseline urea level/baseline urea level \* 100. Percentage of participants meeting the criteria at the facility-level were calculated for each facility first and then summarized across facilities as a continuous variable, weighted by the number of participants in a facility.
Outcome measures
| Measure |
Cohort
n=51 SDO facilities
Patients with end-stage renal disease (ESRD) treated at small dialysis organizations (SDOs).
|
Q1 2011
First quarter (Q1), 2011
|
Q2 2011
Second quarter (Q2), 2011
|
Q3 2011
Third quarter (Q3) 2011
|
Q4 2011
Fourth quarter, 2011
|
|---|---|---|---|---|---|
|
Percentage of Participants Per Facility With Urea Reduction Ratio (URR) ≥ 65%
June 2010 (n=37)
|
84.8 percentage of participants per facility
Interval 81.4 to 88.3
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Per Facility With Urea Reduction Ratio (URR) ≥ 65%
July 2010 (n=44)
|
85.0 percentage of participants per facility
Interval 81.5 to 88.5
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Per Facility With Urea Reduction Ratio (URR) ≥ 65%
August 2010 (n=49)
|
85.0 percentage of participants per facility
Interval 82.5 to 87.5
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Per Facility With Urea Reduction Ratio (URR) ≥ 65%
April 2011 (n=49)
|
87.8 percentage of participants per facility
Interval 85.5 to 90.0
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Per Facility With Urea Reduction Ratio (URR) ≥ 65%
September 2010 (n=50)
|
86.9 percentage of participants per facility
Interval 84.3 to 89.5
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Per Facility With Urea Reduction Ratio (URR) ≥ 65%
October 2010 (n=50)
|
87.9 percentage of participants per facility
Interval 85.2 to 90.3
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Per Facility With Urea Reduction Ratio (URR) ≥ 65%
November 2010 (n=50)
|
87.8 percentage of participants per facility
Interval 85.2 to 90.3
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Per Facility With Urea Reduction Ratio (URR) ≥ 65%
December 2010 (n=50)
|
86.9 percentage of participants per facility
Interval 84.3 to 89.3
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Per Facility With Urea Reduction Ratio (URR) ≥ 65%
January 2011 (n=49)
|
85.5 percentage of participants per facility
Interval 82.1 to 88.7
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Per Facility With Urea Reduction Ratio (URR) ≥ 65%
February 2011 (n=49)
|
86.7 percentage of participants per facility
Interval 83.9 to 89.4
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Per Facility With Urea Reduction Ratio (URR) ≥ 65%
March 2011 (n=49)
|
88.4 percentage of participants per facility
Interval 86.1 to 90.6
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Per Facility With Urea Reduction Ratio (URR) ≥ 65%
May 2011 (n=49)
|
88.8 percentage of participants per facility
Interval 85.9 to 91.4
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Per Facility With Urea Reduction Ratio (URR) ≥ 65%
June 2011 (n=49)
|
90.2 percentage of participants per facility
Interval 88.3 to 92.0
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Per Facility With Urea Reduction Ratio (URR) ≥ 65%
July 2011 (n=49)
|
89.0 percentage of participants per facility
Interval 87.0 to 90.9
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Per Facility With Urea Reduction Ratio (URR) ≥ 65%
August 2011 (n=49)
|
89.0 percentage of participants per facility
Interval 86.9 to 91.0
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Per Facility With Urea Reduction Ratio (URR) ≥ 65%
September 2011 (n=49)
|
89.5 percentage of participants per facility
Interval 87.6 to 91.6
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Per Facility With Urea Reduction Ratio (URR) ≥ 65%
October 2011 (n=49)
|
90.4 percentage of participants per facility
Interval 88.1 to 92.4
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Per Facility With Urea Reduction Ratio (URR) ≥ 65%
November 2011 (n=49)
|
89.2 percentage of participants per facility
Interval 86.0 to 91.9
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Per Facility With Urea Reduction Ratio (URR) ≥ 65%
December 2011 (n=47)
|
90.3 percentage of participants per facility
Interval 88.0 to 92.4
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Per Facility With Urea Reduction Ratio (URR) ≥ 65%
January 2012 (n=47)
|
88.7 percentage of participants per facility
Interval 86.1 to 91.2
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Per Facility With Urea Reduction Ratio (URR) ≥ 65%
February 2012 (n=47)
|
89.3 percentage of participants per facility
Interval 86.9 to 91.5
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Per Facility With Urea Reduction Ratio (URR) ≥ 65%
March 2012 (n=48)
|
89.4 percentage of participants per facility
Interval 87.0 to 91.7
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Per Facility With Urea Reduction Ratio (URR) ≥ 65%
April 2012 (n=47)
|
90.9 percentage of participants per facility
Interval 88.4 to 93.5
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Per Facility With Urea Reduction Ratio (URR) ≥ 65%
May 2012 (n=47)
|
91.1 percentage of participants per facility
Interval 89.1 to 93.1
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Per Facility With Urea Reduction Ratio (URR) ≥ 65%
June 2012 (n=44)
|
91.1 percentage of participants per facility
Interval 89.0 to 92.9
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Per Facility With Urea Reduction Ratio (URR) ≥ 65%
July 2012 (n=44)
|
91.3 percentage of participants per facility
Interval 88.9 to 93.4
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Per Facility With Urea Reduction Ratio (URR) ≥ 65%
August 2012 (n=44)
|
91.4 percentage of participants per facility
Interval 88.8 to 94.0
|
—
|
—
|
—
|
—
|
|
Percentage of Participants Per Facility With Urea Reduction Ratio (URR) ≥ 65%
September 2012 (n=44)
|
93.3 percentage of participants per facility
Interval 91.6 to 95.0
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Fourth quarter (Q4) 2010, Q1 2011, Q2 2011, Q3 2011, and Q4 2011.Population: Primary Analysis Set participants on study at each time point
The percentage of participants treated with peritoneal, hemodialysis (in center) or home hemodialysis over the course of the study. For participants who switched modalities within a quarter, the last current modality is reported.
Outcome measures
| Measure |
Cohort
n=1819 Participants
Patients with end-stage renal disease (ESRD) treated at small dialysis organizations (SDOs).
|
Q1 2011
n=1810 Participants
First quarter (Q1), 2011
|
Q2 2011
n=1701 Participants
Second quarter (Q2), 2011
|
Q3 2011
n=1646 Participants
Third quarter (Q3) 2011
|
Q4 2011
n=1554 Participants
Fourth quarter, 2011
|
|---|---|---|---|---|---|
|
Percentage of Participants Treated by Each Dialysis Modality
Peritoneal
|
2.0 percentage of participants
|
2.2 percentage of participants
|
3.6 percentage of participants
|
2.8 percentage of participants
|
2.9 percentage of participants
|
|
Percentage of Participants Treated by Each Dialysis Modality
Hemodialysis (in center)
|
94.4 percentage of participants
|
93.0 percentage of participants
|
93.0 percentage of participants
|
92.6 percentage of participants
|
93.0 percentage of participants
|
|
Percentage of Participants Treated by Each Dialysis Modality
Home hemodialysis
|
0.5 percentage of participants
|
0.7 percentage of participants
|
0.6 percentage of participants
|
0.7 percentage of participants
|
0.6 percentage of participants
|
|
Percentage of Participants Treated by Each Dialysis Modality
Missing
|
3.0 percentage of participants
|
4.2 percentage of participants
|
2.8 percentage of participants
|
3.9 percentage of participants
|
3.5 percentage of participants
|
SECONDARY outcome
Timeframe: Fourth quarter (Q4) 2010, Q1 2011, Q2 2011, Q3 2011, and Q4 2011.Population: Primary Analysis Set participants on study and on hemodialysis at each time point
The percentage of participants in each vascular access type category out of all enrolled participants on hemodialysis over the course of the study.
Outcome measures
| Measure |
Cohort
n=1718 Participants
Patients with end-stage renal disease (ESRD) treated at small dialysis organizations (SDOs).
|
Q1 2011
n=1683 Participants
First quarter (Q1), 2011
|
Q2 2011
n=1582 Participants
Second quarter (Q2), 2011
|
Q3 2011
n=1524 Participants
Third quarter (Q3) 2011
|
Q4 2011
n=1445 Participants
Fourth quarter, 2011
|
|---|---|---|---|---|---|
|
Percentage of Participants in Each Vascular Access Type Category
Missing
|
0.1 percentage of participants
|
0.1 percentage of participants
|
0.1 percentage of participants
|
0.1 percentage of participants
|
0.1 percentage of participants
|
|
Percentage of Participants in Each Vascular Access Type Category
Arteriovenous fistula
|
62.8 percentage of participants
|
63.2 percentage of participants
|
63.5 percentage of participants
|
63.8 percentage of participants
|
63.7 percentage of participants
|
|
Percentage of Participants in Each Vascular Access Type Category
Arteriovenous graft
|
17.2 percentage of participants
|
16.8 percentage of participants
|
16.2 percentage of participants
|
16.0 percentage of participants
|
15.5 percentage of participants
|
|
Percentage of Participants in Each Vascular Access Type Category
Venous catheter
|
19.9 percentage of participants
|
20.0 percentage of participants
|
20.2 percentage of participants
|
20.1 percentage of participants
|
20.7 percentage of participants
|
SECONDARY outcome
Timeframe: Fourth quarter (Q4) 2010, Q1 2011, Q2 2011, Q3 2011, and Q4 2011.Population: Primary Analysis Set facilities / participants on study at each time point.
The percentage of participants who received erythropoietin stimulation agents (ESA) in a facility over the course of the study. Mean and confidence interval (CI) are calculated across facilities and by using total number of participants actively receiving chronic dialysis in each facility per month as weight.
Outcome measures
| Measure |
Cohort
n=50 Facilities
Patients with end-stage renal disease (ESRD) treated at small dialysis organizations (SDOs).
|
Q1 2011
n=48 Facilities
First quarter (Q1), 2011
|
Q2 2011
n=49 Facilities
Second quarter (Q2), 2011
|
Q3 2011
n=49 Facilities
Third quarter (Q3) 2011
|
Q4 2011
n=47 Facilities
Fourth quarter, 2011
|
|---|---|---|---|---|---|
|
Percentage of Participants Per Facility Receiving Erythropoietin Stimulation Agents (ESA)
|
91.2 percentage of participants per facility
Interval 87.0 to 94.5
|
92.0 percentage of participants per facility
Interval 89.1 to 94.5
|
90.9 percentage of participants per facility
Interval 87.7 to 93.7
|
91.2 percentage of participants per facility
Interval 88.5 to 94.0
|
89.4 percentage of participants per facility
Interval 86.4 to 92.2
|
SECONDARY outcome
Timeframe: Fourth quarter (Q4) 2010, Q1 2011, Q2 2011, Q3 2011, and Q4 2011.Population: Primary Analysis Set participants on study at each time point
The percentage of participants receiving cinacalcet (Sensipar) over time
Outcome measures
| Measure |
Cohort
n=1819 Participants
Patients with end-stage renal disease (ESRD) treated at small dialysis organizations (SDOs).
|
Q1 2011
n=1810 Participants
First quarter (Q1), 2011
|
Q2 2011
n=1701 Participants
Second quarter (Q2), 2011
|
Q3 2011
n=1646 Participants
Third quarter (Q3) 2011
|
Q4 2011
n=1554 Participants
Fourth quarter, 2011
|
|---|---|---|---|---|---|
|
Percentage of Participants Receiving Cinacalcet
|
22.3 percentage of participants
|
26.2 percentage of participants
|
29.3 percentage of participants
|
30.0 percentage of participants
|
31.0 percentage of participants
|
SECONDARY outcome
Timeframe: Fourth quarter (Q4) 2010, Q1 2011, Q2 2011, Q3 2011, and Q4 2011.Population: Primary Analysis Set participants on study at each time point
The percentage of participants receiving phosphate binding agents over time
Outcome measures
| Measure |
Cohort
n=1819 Participants
Patients with end-stage renal disease (ESRD) treated at small dialysis organizations (SDOs).
|
Q1 2011
n=1810 Participants
First quarter (Q1), 2011
|
Q2 2011
n=1701 Participants
Second quarter (Q2), 2011
|
Q3 2011
n=1646 Participants
Third quarter (Q3) 2011
|
Q4 2011
n=1554 Participants
Fourth quarter, 2011
|
|---|---|---|---|---|---|
|
Percentage of Participants Receiving Phosphate Binding Agents
|
60.9 percentage of participants
|
66.0 percentage of participants
|
70.4 percentage of participants
|
74.2 percentage of participants
|
73.3 percentage of participants
|
SECONDARY outcome
Timeframe: Fourth quarter (Q4) 2010, Q1 2011, Q2 2011, Q3 2011, and Q4 2011.Population: Primary Analysis Set participants on study at each time point
The percentage of participants receiving a vitamin D sterol (ie, calcitriol, alfacalcidol, paricalcitol or doxercalciferol) over time. Note that participants could receive more than one type of vitamin D sterol.
Outcome measures
| Measure |
Cohort
n=1819 Participants
Patients with end-stage renal disease (ESRD) treated at small dialysis organizations (SDOs).
|
Q1 2011
n=1810 Participants
First quarter (Q1), 2011
|
Q2 2011
n=1701 Participants
Second quarter (Q2), 2011
|
Q3 2011
n=1646 Participants
Third quarter (Q3) 2011
|
Q4 2011
n=1554 Participants
Fourth quarter, 2011
|
|---|---|---|---|---|---|
|
Percentage of Participants Receiving a Vitamin D Sterol
Any Vitamin D sterol
|
80.6 percentage of participants
|
76.2 percentage of participants
|
77.5 percentage of participants
|
77.7 percentage of participants
|
79.4 percentage of participants
|
|
Percentage of Participants Receiving a Vitamin D Sterol
Intravenous
|
76.0 percentage of participants
|
68.0 percentage of participants
|
66.5 percentage of participants
|
62.6 percentage of participants
|
62.7 percentage of participants
|
|
Percentage of Participants Receiving a Vitamin D Sterol
Oral - activated
|
7.6 percentage of participants
|
10.3 percentage of participants
|
15.3 percentage of participants
|
16.2 percentage of participants
|
17.7 percentage of participants
|
|
Percentage of Participants Receiving a Vitamin D Sterol
Oral - not activated
|
2.3 percentage of participants
|
5.9 percentage of participants
|
6.7 percentage of participants
|
9.1 percentage of participants
|
9.7 percentage of participants
|
SECONDARY outcome
Timeframe: Fourth quarter (Q4) 2010, Q1 2011, Q2 2011, Q3 2011, and Q4 2011.Population: Primary Analysis Set participants on study at each time point and with available data.
Outcome measures
| Measure |
Cohort
n=1797 Participants
Patients with end-stage renal disease (ESRD) treated at small dialysis organizations (SDOs).
|
Q1 2011
n=1773 Participants
First quarter (Q1), 2011
|
Q2 2011
n=1675 Participants
Second quarter (Q2), 2011
|
Q3 2011
n=1610 Participants
Third quarter (Q3) 2011
|
Q4 2011
n=1525 Participants
Fourth quarter, 2011
|
|---|---|---|---|---|---|
|
Mean Hemoglobin Concentration by Quarter
|
11.28 g/dL
Standard Deviation 1.35
|
11.17 g/dL
Standard Deviation 1.35
|
11.06 g/dL
Standard Deviation 1.25
|
11.00 g/dL
Standard Deviation 1.32
|
10.78 g/dL
Standard Deviation 1.22
|
SECONDARY outcome
Timeframe: December 2010, March 2011, June 2011, September 2011, December 2011Population: Facilities with at least one non-missing hemoglobin record, for participants included in the primary analysis set who were on study and with available data at each time point.
Facilities were categorized over time based on the percentage of participants at the facility with hemoglobin \< 10 g/dL: Faciities with 0 to \<5% of participants with hemoglobin \< 10 g/dL; Facilities with 5 to \< 10% of participants with hemoglobin \< 10 g/dL; Facilities with 10 to \< 15% participants with hemoglobin \< 10 g/dL; Facilities with 15 to \< 20% of participants with hemoglobin \< 10 g/dL; Facilities with ≥ 20% of participants with hemoglobin \< 10 g/dL.
Outcome measures
| Measure |
Cohort
n=51 Facilities
Patients with end-stage renal disease (ESRD) treated at small dialysis organizations (SDOs).
|
Q1 2011
n=50 Facilities
First quarter (Q1), 2011
|
Q2 2011
n=50 Facilities
Second quarter (Q2), 2011
|
Q3 2011
n=50 Facilities
Third quarter (Q3) 2011
|
Q4 2011
n=48 Facilities
Fourth quarter, 2011
|
|---|---|---|---|---|---|
|
Distribution of Facilities With Percentage of Participants With Hemoglobin < 10 g/dL Over Time
0%-<5% of participants with hemoglobin < 10 g/dL
|
11.8 percentage of facilities
1.36
|
10.0 percentage of facilities
1.33
|
10.0 percentage of facilities
1.23
|
4.0 percentage of facilities
1.29
|
6.3 percentage of facilities
1.21
|
|
Distribution of Facilities With Percentage of Participants With Hemoglobin < 10 g/dL Over Time
5%-<10% of participants with hemoglobin <10 g/dL
|
21.6 percentage of facilities
|
22.0 percentage of facilities
|
20.0 percentage of facilities
|
16.0 percentage of facilities
|
8.3 percentage of facilities
|
|
Distribution of Facilities With Percentage of Participants With Hemoglobin < 10 g/dL Over Time
10%-<15% of participants with hemoglobin <10 g/dL
|
29.4 percentage of facilities
|
24.0 percentage of facilities
|
20.0 percentage of facilities
|
18.0 percentage of facilities
|
16.7 percentage of facilities
|
|
Distribution of Facilities With Percentage of Participants With Hemoglobin < 10 g/dL Over Time
15%-<20% of participants with hemoglobin <10 g/dL
|
11.8 percentage of facilities
|
18.0 percentage of facilities
|
10.0 percentage of facilities
|
20.0 percentage of facilities
|
16.7 percentage of facilities
|
|
Distribution of Facilities With Percentage of Participants With Hemoglobin < 10 g/dL Over Time
≥20% of participants with hemoglobin <10 g/dL
|
25.5 percentage of facilities
|
26.0 percentage of facilities
|
40.0 percentage of facilities
|
42.0 percentage of facilities
|
52.1 percentage of facilities
|
SECONDARY outcome
Timeframe: December 2010, March 2011, June 2011, September 2011, December 2011Population: Facilities / participants with at least one non-missing transferrin saturation or ferritin record at each time point.
The mean percentage of participants per facility with transferrin saturation \< 20% and ferritin level \< 100 ng/mL. Mean and CI are calculated across facilities and by using number of participants with non-missing transferrin saturation and ferritin in each facility as weight.
Outcome measures
| Measure |
Cohort
n=46 Facilities
Patients with end-stage renal disease (ESRD) treated at small dialysis organizations (SDOs).
|
Q1 2011
n=43 Facilities
First quarter (Q1), 2011
|
Q2 2011
n=44 Facilities
Second quarter (Q2), 2011
|
Q3 2011
n=43 Facilities
Third quarter (Q3) 2011
|
Q4 2011
n=40 Facilities
Fourth quarter, 2011
|
|---|---|---|---|---|---|
|
Percentage of Participants Per Facility With Transferrin Saturation < 20% and Ferritin Level < 100 ng/mL
|
2.4 percentage of participants per facility
95% Confidence Interval 1.36 • Interval 1.5 to 3.5
|
0.6 percentage of participants per facility
95% Confidence Interval 1.33 • Interval 0.2 to 1.1
|
1.4 percentage of participants per facility
95% Confidence Interval 1.23 • Interval 0.2 to 3.0
|
1.0 percentage of participants per facility
95% Confidence Interval 1.29 • Interval 0.4 to 1.7
|
0.7 percentage of participants per facility
95% Confidence Interval 1.21 • Interval 0.3 to 1.2
|
SECONDARY outcome
Timeframe: December 2010, March 2011, June 2011, September 2011, December 2011Population: Primary Analysis Set participants on study and on hemodialysis and receiving epoetin alfa at each time point and with available data.
The cumulative monthly intravenous epoetin alfa dose in participants on hemodialysis.
Outcome measures
| Measure |
Cohort
n=1172 Participants
Patients with end-stage renal disease (ESRD) treated at small dialysis organizations (SDOs).
|
Q1 2011
n=1188 Participants
First quarter (Q1), 2011
|
Q2 2011
n=1105 Participants
Second quarter (Q2), 2011
|
Q3 2011
n=1096 Participants
Third quarter (Q3) 2011
|
Q4 2011
n=984 Participants
Fourth quarter, 2011
|
|---|---|---|---|---|---|
|
Cumulative Monthly Dose of Epoetin Alfa Administered
|
39000.0 units
Interval 19100.0 to 71500.0
|
35000.0 units
Interval 16650.0 to 66000.0
|
33800.0 units
Interval 15400.0 to 65000.0
|
28000.0 units
Interval 13000.0 to 52000.0
|
32900.0 units
Interval 16000.0 to 60000.0
|
SECONDARY outcome
Timeframe: December 2010, March 2011, June 2011, September 2011, December 2011Population: Primary Analysis Set participants on study and on hemodialysis at each time point.
The number of participants who took epoetin alfa only, by month, in participants on hemodialysis.
Outcome measures
| Measure |
Cohort
n=1645 Participants
Patients with end-stage renal disease (ESRD) treated at small dialysis organizations (SDOs).
|
Q1 2011
n=1566 Participants
First quarter (Q1), 2011
|
Q2 2011
n=1499 Participants
Second quarter (Q2), 2011
|
Q3 2011
n=1421 Participants
Third quarter (Q3) 2011
|
Q4 2011
n=1342 Participants
Fourth quarter, 2011
|
|---|---|---|---|---|---|
|
Number of Participants Taking Epoetin Alfa by Month
|
1269 participants
57684.5
|
1299 participants
52423.4
|
1244 participants
51344.7
|
1212 participants
48175.3
|
1140 participants
47792.1
|
SECONDARY outcome
Timeframe: June to December 2010, Q1 2011, Q2 2011, Q3 2011, and Q4 2011.Population: Primary Analysis Set participants on study at each time point
Outcome measures
| Measure |
Cohort
n=1873 Participants
Patients with end-stage renal disease (ESRD) treated at small dialysis organizations (SDOs).
|
Q1 2011
n=1810 Participants
First quarter (Q1), 2011
|
Q2 2011
n=1701 Participants
Second quarter (Q2), 2011
|
Q3 2011
n=1646 Participants
Third quarter (Q3) 2011
|
Q4 2011
n=1554 Participants
Fourth quarter, 2011
|
|---|---|---|---|---|---|
|
Number of Participants With Transfusions, Hospitalizations, Mortality, and Transfers Out
Participants who transferred out
|
63 participants
|
51 participants
|
31 participants
|
47 participants
|
21 participants
|
|
Number of Participants With Transfusions, Hospitalizations, Mortality, and Transfers Out
Participants with transfusions
|
54 participants
|
56 participants
|
50 participants
|
39 participants
|
36 participants
|
|
Number of Participants With Transfusions, Hospitalizations, Mortality, and Transfers Out
Participants who died
|
71 participants
|
67 participants
|
52 participants
|
55 participants
|
46 participants
|
|
Number of Participants With Transfusions, Hospitalizations, Mortality, and Transfers Out
Participants with hospitalizations
|
574 participants
|
445 participants
|
354 participants
|
296 participants
|
275 participants
|
Adverse Events
Cohort
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort
n=2248 participants at risk
Patients with end-stage renal disease (ESRD) treated at small dialysis organizations (SDOs).
|
|---|---|
|
Nervous system disorders
Cerebrovascular accident
|
0.04%
1/2248 • Up to 28 months
As this was a non-interventional observational study, only serious adverse drug reactions (SADRs) relating to Amgen products were reported. An adverse drug reaction (ADR) was defined for this study as any undesirable experience or worsening of a pre-existing medical condition associated with the use of a medicine in a clinical study participant.
|
|
Nervous system disorders
Convulsion
|
0.04%
1/2248 • Up to 28 months
As this was a non-interventional observational study, only serious adverse drug reactions (SADRs) relating to Amgen products were reported. An adverse drug reaction (ADR) was defined for this study as any undesirable experience or worsening of a pre-existing medical condition associated with the use of a medicine in a clinical study participant.
|
Other adverse events
Adverse event data not reported
Additional Information
Study Director
Amgen Inc.
Phone: 866-572-6436
Results disclosure agreements
- Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results aftercompletion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
- Publication restrictions are in place
Restriction type: OTHER