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Study to Evaluate the Prospective Payment System

Study to Evaluate the Prospective Payment System Impact on Small Dialysis Organizations

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01717989
Acronym
STEPPS™
Enrollment
2248
Registered
2012-10-31
Start date
2010-06-30
Completion date
2012-09-30
Last updated
2014-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Disease

Keywords

Dialysis, Prospective Payment System, Center for Medicare and Medicaide Services, End Stage Renal Disease, Concomitant Medications Dosage /Treatment patterns

Brief summary

To describe trends in treatment patterns of Small Dialysis Organizations (SDOs) prior to and during the implementation of the Centers for Medicare and Medicaid Services' (CMS') policy \[End Stage Renal Disease (ESRD) Prospective Payment System (PPS)\] to bundle reimbursement for all dialysis services. Specifically, to describe CMS ESRD PPS quality performance measures for dialysis centers over time.

Interventions

None listed

Sponsors

Amgen
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

Patient Inclusion Criteria: * Adults ≥ 18 years of age who have given written informed consent * Documented physician diagnosis of ESRD requiring dialysis and receiving care at a participating dialysis center * Undergoing dialysis on the dialysis schedule assigned to the site Patient

Exclusion criteria

* Patients will be ineligible for the study if they do not consent to have their data collected for research purposes.

Design outcomes

Primary

MeasureTime frameDescription
Percentage of Participants Per Facility With Hemoglobin < 10 g/dLData were collected monthly from June 2010 until September 2012The 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.
Percentage of Participants Per Facility With Hemoglobin > 12 g/dLData were collected monthly from June 2010 until September 2012The 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.
Percentage of Participants Per Facility With Urea Reduction Ratio (URR) ≥ 65%Data were collected monthly from June 2010 until September 2012The 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.

Secondary

MeasureTime frameDescription
Percentage of Participants Receiving CinacalcetFourth quarter (Q4) 2010, Q1 2011, Q2 2011, Q3 2011, and Q4 2011.The percentage of participants receiving cinacalcet (Sensipar) over time
Percentage of Participants Receiving Phosphate Binding AgentsFourth quarter (Q4) 2010, Q1 2011, Q2 2011, Q3 2011, and Q4 2011.The percentage of participants receiving phosphate binding agents over time
Percentage of Participants Receiving a Vitamin D SterolFourth quarter (Q4) 2010, Q1 2011, Q2 2011, Q3 2011, and Q4 2011.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.
Mean Hemoglobin Concentration by QuarterFourth quarter (Q4) 2010, Q1 2011, Q2 2011, Q3 2011, and Q4 2011.
Percentage of Participants Treated by Each Dialysis ModalityFourth quarter (Q4) 2010, Q1 2011, Q2 2011, Q3 2011, and Q4 2011.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.
Percentage of Participants Per Facility With Transferrin Saturation < 20% and Ferritin Level < 100 ng/mLDecember 2010, March 2011, June 2011, September 2011, December 2011The 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.
Cumulative Monthly Dose of Epoetin Alfa AdministeredDecember 2010, March 2011, June 2011, September 2011, December 2011The cumulative monthly intravenous epoetin alfa dose in participants on hemodialysis.
Number of Participants Taking Epoetin Alfa by MonthDecember 2010, March 2011, June 2011, September 2011, December 2011The number of participants who took epoetin alfa only, by month, in participants on hemodialysis.
Number of Participants With Transfusions, Hospitalizations, Mortality, and Transfers OutJune to December 2010, Q1 2011, Q2 2011, Q3 2011, and Q4 2011.
Distribution of Facilities With Percentage of Participants With Hemoglobin < 10 g/dL Over TimeDecember 2010, March 2011, June 2011, September 2011, December 2011Facilities 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.
Percentage of Participants in Each Vascular Access Type CategoryFourth quarter (Q4) 2010, Q1 2011, Q2 2011, Q3 2011, and Q4 2011.The percentage of participants in each vascular access type category out of all enrolled participants on hemodialysis over the course of the study.
Percentage of Participants Per Facility Receiving Erythropoietin Stimulation Agents (ESA)Fourth quarter (Q4) 2010, Q1 2011, Q2 2011, Q3 2011, and Q4 2011.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.

Countries

Puerto Rico, United States

Participant flow

Recruitment details

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.

Participants by arm

ArmCount
Cohort
Patients with end-stage renal disease (ESRD) treated at small dialysis organizations (SDOs).
2,248
Total2,248

Withdrawals & dropouts

PeriodReasonFG000
Overall StudyDeath439
Overall StudyIneligibility determined6
Overall StudyLost to Follow-up11
Overall StudyOther40
Overall StudyPhysician Decision2
Overall StudyProtocol deviation6
Overall StudyProtocol-specified criteria551
Overall StudyWithdrawal by Subject11

Baseline characteristics

CharacteristicCohort
Age, Continuous61.1 years
STANDARD_DEVIATION 15.4
Dialysis modality at enrollment
Hemodialysis (in center)
2107 participants
Dialysis modality at enrollment
Home hemodialysis
13 participants
Dialysis modality at enrollment
Missing
3 participants
Dialysis modality at enrollment
Peritoneal
125 participants
Race/Ethnicity, Customized
American Indian or Alaska Native
7 participants
Race/Ethnicity, Customized
Asian/Pacific Islander
258 participants
Race/Ethnicity, Customized
Black or African American
557 participants
Race/Ethnicity, Customized
Hispanic or Latino
646 participants
Race/Ethnicity, Customized
Neither Hispanic or Latino
1602 participants
Race/Ethnicity, Customized
Other
171 participants
Race/Ethnicity, Customized
Unknown
9 participants
Race/Ethnicity, Customized
White
1246 participants
Sex: Female, Male
Female
966 Participants
Sex: Female, Male
Male
1282 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
0 / 0
serious
Total, serious adverse events
1 / 2,248

Outcome results

Primary

Percentage of Participants Per Facility With Hemoglobin < 10 g/dL

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.

Time frame: Data were collected monthly from June 2010 until September 2012

Population: 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).

ArmMeasureGroupValue (MEAN)
CohortPercentage of Participants Per Facility With Hemoglobin < 10 g/dLJune 2011 (n=50)16.7 percentage of participants per facility
CohortPercentage of Participants Per Facility With Hemoglobin < 10 g/dLJuly 2011 (n=50)14.0 percentage of participants per facility
CohortPercentage of Participants Per Facility With Hemoglobin < 10 g/dLAugust 2011 (n=50)15.5 percentage of participants per facility
CohortPercentage of Participants Per Facility With Hemoglobin < 10 g/dLSeptember 2011 (n=50)19.3 percentage of participants per facility
CohortPercentage of Participants Per Facility With Hemoglobin < 10 g/dLOctober 2011 (n=50)21.7 percentage of participants per facility
CohortPercentage of Participants Per Facility With Hemoglobin < 10 g/dLNovember 2011 (n=50)22.2 percentage of participants per facility
CohortPercentage of Participants Per Facility With Hemoglobin < 10 g/dLDecember 2011 (n=48)21.8 percentage of participants per facility
CohortPercentage of Participants Per Facility With Hemoglobin < 10 g/dLJanuary 2012 (n=48)22.0 percentage of participants per facility
CohortPercentage of Participants Per Facility With Hemoglobin < 10 g/dLFebruary 2012 (n=48)19.5 percentage of participants per facility
CohortPercentage of Participants Per Facility With Hemoglobin < 10 g/dLMarch 2012 (n=48)23.3 percentage of participants per facility
CohortPercentage of Participants Per Facility With Hemoglobin < 10 g/dLApril 2012 (n=48)24.0 percentage of participants per facility
CohortPercentage of Participants Per Facility With Hemoglobin < 10 g/dLMay 2012 (n=48)25.1 percentage of participants per facility
CohortPercentage of Participants Per Facility With Hemoglobin < 10 g/dLJune 2012 (n=45)24.6 percentage of participants per facility
CohortPercentage of Participants Per Facility With Hemoglobin < 10 g/dLJuly 2012 (n=45)23.1 percentage of participants per facility
CohortPercentage of Participants Per Facility With Hemoglobin < 10 g/dLAugust 2012 (n=45)22.6 percentage of participants per facility
CohortPercentage of Participants Per Facility With Hemoglobin < 10 g/dLSeptember 2012 (n=45)22.2 percentage of participants per facility
CohortPercentage of Participants Per Facility With Hemoglobin < 10 g/dLJune 2010 (n=39)11.5 percentage of participants per facility
CohortPercentage of Participants Per Facility With Hemoglobin < 10 g/dLJuly 2010 (n=45)11.0 percentage of participants per facility
CohortPercentage of Participants Per Facility With Hemoglobin < 10 g/dLAugust 2010 (n=50)13.1 percentage of participants per facility
CohortPercentage of Participants Per Facility With Hemoglobin < 10 g/dLSeptember 2010 (n=51)12.0 percentage of participants per facility
CohortPercentage of Participants Per Facility With Hemoglobin < 10 g/dLOctober 2010 (n=51)12.7 percentage of participants per facility
CohortPercentage of Participants Per Facility With Hemoglobin < 10 g/dLNovember 2010 (n=51)13.2 percentage of participants per facility
CohortPercentage of Participants Per Facility With Hemoglobin < 10 g/dLDecember 2010 (n=51)14.3 percentage of participants per facility
CohortPercentage of Participants Per Facility With Hemoglobin < 10 g/dLJanuary 2011 (n=50)13.5 percentage of participants per facility
CohortPercentage of Participants Per Facility With Hemoglobin < 10 g/dLFebruary 2011 (n=50)18.3 percentage of participants per facility
CohortPercentage of Participants Per Facility With Hemoglobin < 10 g/dLMarch 2011 (n=50)16.4 percentage of participants per facility
CohortPercentage of Participants Per Facility With Hemoglobin < 10 g/dLApril 2011 (n=50)16.9 percentage of participants per facility
CohortPercentage of Participants Per Facility With Hemoglobin < 10 g/dLMay 2011 (n=50)15.4 percentage of participants per facility
Primary

Percentage of Participants Per Facility With Hemoglobin > 12 g/dL

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.

Time frame: Data were collected monthly from June 2010 until September 2012

Population: 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).

ArmMeasureGroupValue (MEAN)
CohortPercentage of Participants Per Facility With Hemoglobin > 12 g/dLJune 2010 (n=39)30.2 percentage of participants per facility
CohortPercentage of Participants Per Facility With Hemoglobin > 12 g/dLJuly 2010 (n=45)28.3 percentage of participants per facility
CohortPercentage of Participants Per Facility With Hemoglobin > 12 g/dLAugust 2010 (n=50)28.2 percentage of participants per facility
CohortPercentage of Participants Per Facility With Hemoglobin > 12 g/dLSeptember 2010 (n=51)30.6 percentage of participants per facility
CohortPercentage of Participants Per Facility With Hemoglobin > 12 g/dLOctober 2010 (n=51)28.7 percentage of participants per facility
CohortPercentage of Participants Per Facility With Hemoglobin > 12 g/dLNovember 2010 (n=51)27.8 percentage of participants per facility
CohortPercentage of Participants Per Facility With Hemoglobin > 12 g/dLDecember 2010 (n=51)24.5 percentage of participants per facility
CohortPercentage of Participants Per Facility With Hemoglobin > 12 g/dLJanuary 2011 (n=50)25.6 percentage of participants per facility
CohortPercentage of Participants Per Facility With Hemoglobin > 12 g/dLFebruary 2011 (n=50)24.5 percentage of participants per facility
CohortPercentage of Participants Per Facility With Hemoglobin > 12 g/dLMarch 2011 (n=50)22.8 percentage of participants per facility
CohortPercentage of Participants Per Facility With Hemoglobin > 12 g/dLApril 2011 (n=50)21.8 percentage of participants per facility
CohortPercentage of Participants Per Facility With Hemoglobin > 12 g/dLMay 2011 (n=50)23.2 percentage of participants per facility
CohortPercentage of Participants Per Facility With Hemoglobin > 12 g/dLJune 2011 (n=50)18.5 percentage of participants per facility
CohortPercentage of Participants Per Facility With Hemoglobin > 12 g/dLJuly 2011 (n=50)20.2 percentage of participants per facility
CohortPercentage of Participants Per Facility With Hemoglobin > 12 g/dLAugust 2011 (n=50)19.0 percentage of participants per facility
CohortPercentage of Participants Per Facility With Hemoglobin > 12 g/dLSeptember 2011 (n=50)18.2 percentage of participants per facility
CohortPercentage of Participants Per Facility With Hemoglobin > 12 g/dLOctober 2011 (n=50)14.3 percentage of participants per facility
CohortPercentage of Participants Per Facility With Hemoglobin > 12 g/dLNovember 2011 (n=50)11.5 percentage of participants per facility
CohortPercentage of Participants Per Facility With Hemoglobin > 12 g/dLDecember 2011 (n=48)11.8 percentage of participants per facility
CohortPercentage of Participants Per Facility With Hemoglobin > 12 g/dLJanuary 2012 (n=48)13.7 percentage of participants per facility
CohortPercentage of Participants Per Facility With Hemoglobin > 12 g/dLFebruary 2012 (n=48)12.5 percentage of participants per facility
CohortPercentage of Participants Per Facility With Hemoglobin > 12 g/dLMarch 2012 (n=48)11.2 percentage of participants per facility
CohortPercentage of Participants Per Facility With Hemoglobin > 12 g/dLApril 2012 (n=48)10.3 percentage of participants per facility
CohortPercentage of Participants Per Facility With Hemoglobin > 12 g/dLMay 2012 (n=48)11.6 percentage of participants per facility
CohortPercentage of Participants Per Facility With Hemoglobin > 12 g/dLJune 2012 (n=45)12.1 percentage of participants per facility
CohortPercentage of Participants Per Facility With Hemoglobin > 12 g/dLJuly 2012 (n=45)11.9 percentage of participants per facility
CohortPercentage of Participants Per Facility With Hemoglobin > 12 g/dLAugust 2012 (n=45)11.6 percentage of participants per facility
CohortPercentage of Participants Per Facility With Hemoglobin > 12 g/dLSeptember 2012 (n=45)13.1 percentage of participants per facility
Primary

Percentage of Participants Per Facility With Urea Reduction Ratio (URR) ≥ 65%

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.

Time frame: Data were collected monthly from June 2010 until September 2012

Population: 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).

ArmMeasureGroupValue (MEAN)
CohortPercentage of Participants Per Facility With Urea Reduction Ratio (URR) ≥ 65%June 2010 (n=37)84.8 percentage of participants per facility
CohortPercentage of Participants Per Facility With Urea Reduction Ratio (URR) ≥ 65%July 2010 (n=44)85.0 percentage of participants per facility
CohortPercentage of Participants Per Facility With Urea Reduction Ratio (URR) ≥ 65%August 2010 (n=49)85.0 percentage of participants per facility
CohortPercentage of Participants Per Facility With Urea Reduction Ratio (URR) ≥ 65%September 2010 (n=50)86.9 percentage of participants per facility
CohortPercentage of Participants Per Facility With Urea Reduction Ratio (URR) ≥ 65%October 2010 (n=50)87.9 percentage of participants per facility
CohortPercentage of Participants Per Facility With Urea Reduction Ratio (URR) ≥ 65%November 2010 (n=50)87.8 percentage of participants per facility
CohortPercentage of Participants Per Facility With Urea Reduction Ratio (URR) ≥ 65%December 2010 (n=50)86.9 percentage of participants per facility
CohortPercentage of Participants Per Facility With Urea Reduction Ratio (URR) ≥ 65%January 2011 (n=49)85.5 percentage of participants per facility
CohortPercentage of Participants Per Facility With Urea Reduction Ratio (URR) ≥ 65%February 2011 (n=49)86.7 percentage of participants per facility
CohortPercentage of Participants Per Facility With Urea Reduction Ratio (URR) ≥ 65%March 2011 (n=49)88.4 percentage of participants per facility
CohortPercentage of Participants Per Facility With Urea Reduction Ratio (URR) ≥ 65%April 2011 (n=49)87.8 percentage of participants per facility
CohortPercentage of Participants Per Facility With Urea Reduction Ratio (URR) ≥ 65%May 2011 (n=49)88.8 percentage of participants per facility
CohortPercentage of Participants Per Facility With Urea Reduction Ratio (URR) ≥ 65%June 2011 (n=49)90.2 percentage of participants per facility
CohortPercentage of Participants Per Facility With Urea Reduction Ratio (URR) ≥ 65%July 2011 (n=49)89.0 percentage of participants per facility
CohortPercentage of Participants Per Facility With Urea Reduction Ratio (URR) ≥ 65%August 2011 (n=49)89.0 percentage of participants per facility
CohortPercentage of Participants Per Facility With Urea Reduction Ratio (URR) ≥ 65%September 2011 (n=49)89.5 percentage of participants per facility
CohortPercentage of Participants Per Facility With Urea Reduction Ratio (URR) ≥ 65%October 2011 (n=49)90.4 percentage of participants per facility
CohortPercentage of Participants Per Facility With Urea Reduction Ratio (URR) ≥ 65%November 2011 (n=49)89.2 percentage of participants per facility
CohortPercentage of Participants Per Facility With Urea Reduction Ratio (URR) ≥ 65%December 2011 (n=47)90.3 percentage of participants per facility
CohortPercentage of Participants Per Facility With Urea Reduction Ratio (URR) ≥ 65%January 2012 (n=47)88.7 percentage of participants per facility
CohortPercentage of Participants Per Facility With Urea Reduction Ratio (URR) ≥ 65%February 2012 (n=47)89.3 percentage of participants per facility
CohortPercentage of Participants Per Facility With Urea Reduction Ratio (URR) ≥ 65%March 2012 (n=48)89.4 percentage of participants per facility
CohortPercentage of Participants Per Facility With Urea Reduction Ratio (URR) ≥ 65%April 2012 (n=47)90.9 percentage of participants per facility
CohortPercentage of Participants Per Facility With Urea Reduction Ratio (URR) ≥ 65%May 2012 (n=47)91.1 percentage of participants per facility
CohortPercentage of Participants Per Facility With Urea Reduction Ratio (URR) ≥ 65%June 2012 (n=44)91.1 percentage of participants per facility
CohortPercentage of Participants Per Facility With Urea Reduction Ratio (URR) ≥ 65%July 2012 (n=44)91.3 percentage of participants per facility
CohortPercentage of Participants Per Facility With Urea Reduction Ratio (URR) ≥ 65%August 2012 (n=44)91.4 percentage of participants per facility
CohortPercentage of Participants Per Facility With Urea Reduction Ratio (URR) ≥ 65%September 2012 (n=44)93.3 percentage of participants per facility
Secondary

Cumulative Monthly Dose of Epoetin Alfa Administered

The cumulative monthly intravenous epoetin alfa dose in participants on hemodialysis.

Time frame: December 2010, March 2011, June 2011, September 2011, December 2011

Population: Primary Analysis Set participants on study and on hemodialysis and receiving epoetin alfa at each time point and with available data.

ArmMeasureValue (MEDIAN)
CohortCumulative Monthly Dose of Epoetin Alfa Administered39000.0 units
Q1 2011Cumulative Monthly Dose of Epoetin Alfa Administered35000.0 units
Q2 2011Cumulative Monthly Dose of Epoetin Alfa Administered33800.0 units
Q3 2011Cumulative Monthly Dose of Epoetin Alfa Administered28000.0 units
Q4 2011Cumulative Monthly Dose of Epoetin Alfa Administered32900.0 units
Secondary

Distribution of Facilities With Percentage of Participants With Hemoglobin < 10 g/dL Over Time

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.

Time frame: December 2010, March 2011, June 2011, September 2011, December 2011

Population: 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.

ArmMeasureGroupValue (NUMBER)Dispersion
CohortDistribution of Facilities With Percentage of Participants With Hemoglobin < 10 g/dL Over Time15%-<20% of participants with hemoglobin <10 g/dL11.8 percentage of facilities
CohortDistribution of Facilities With Percentage of Participants With Hemoglobin < 10 g/dL Over Time0%-<5% of participants with hemoglobin < 10 g/dL11.8 percentage of facilities 1.36
CohortDistribution of Facilities With Percentage of Participants With Hemoglobin < 10 g/dL Over Time≥20% of participants with hemoglobin <10 g/dL25.5 percentage of facilities
CohortDistribution of Facilities With Percentage of Participants With Hemoglobin < 10 g/dL Over Time5%-<10% of participants with hemoglobin <10 g/dL21.6 percentage of facilities
CohortDistribution of Facilities With Percentage of Participants With Hemoglobin < 10 g/dL Over Time10%-<15% of participants with hemoglobin <10 g/dL29.4 percentage of facilities
Q1 2011Distribution of Facilities With Percentage of Participants With Hemoglobin < 10 g/dL Over Time15%-<20% of participants with hemoglobin <10 g/dL18.0 percentage of facilities
Q1 2011Distribution of Facilities With Percentage of Participants With Hemoglobin < 10 g/dL Over Time10%-<15% of participants with hemoglobin <10 g/dL24.0 percentage of facilities
Q1 2011Distribution of Facilities With Percentage of Participants With Hemoglobin < 10 g/dL Over Time5%-<10% of participants with hemoglobin <10 g/dL22.0 percentage of facilities
Q1 2011Distribution of Facilities With Percentage of Participants With Hemoglobin < 10 g/dL Over Time≥20% of participants with hemoglobin <10 g/dL26.0 percentage of facilities
Q1 2011Distribution of Facilities With Percentage of Participants With Hemoglobin < 10 g/dL Over Time0%-<5% of participants with hemoglobin < 10 g/dL10.0 percentage of facilities 1.33
Q2 2011Distribution of Facilities With Percentage of Participants With Hemoglobin < 10 g/dL Over Time10%-<15% of participants with hemoglobin <10 g/dL20.0 percentage of facilities
Q2 2011Distribution of Facilities With Percentage of Participants With Hemoglobin < 10 g/dL Over Time0%-<5% of participants with hemoglobin < 10 g/dL10.0 percentage of facilities 1.23
Q2 2011Distribution of Facilities With Percentage of Participants With Hemoglobin < 10 g/dL Over Time5%-<10% of participants with hemoglobin <10 g/dL20.0 percentage of facilities
Q2 2011Distribution of Facilities With Percentage of Participants With Hemoglobin < 10 g/dL Over Time15%-<20% of participants with hemoglobin <10 g/dL10.0 percentage of facilities
Q2 2011Distribution of Facilities With Percentage of Participants With Hemoglobin < 10 g/dL Over Time≥20% of participants with hemoglobin <10 g/dL40.0 percentage of facilities
Q3 2011Distribution of Facilities With Percentage of Participants With Hemoglobin < 10 g/dL Over Time≥20% of participants with hemoglobin <10 g/dL42.0 percentage of facilities
Q3 2011Distribution of Facilities With Percentage of Participants With Hemoglobin < 10 g/dL Over Time0%-<5% of participants with hemoglobin < 10 g/dL4.0 percentage of facilities 1.29
Q3 2011Distribution of Facilities With Percentage of Participants With Hemoglobin < 10 g/dL Over Time15%-<20% of participants with hemoglobin <10 g/dL20.0 percentage of facilities
Q3 2011Distribution of Facilities With Percentage of Participants With Hemoglobin < 10 g/dL Over Time10%-<15% of participants with hemoglobin <10 g/dL18.0 percentage of facilities
Q3 2011Distribution of Facilities With Percentage of Participants With Hemoglobin < 10 g/dL Over Time5%-<10% of participants with hemoglobin <10 g/dL16.0 percentage of facilities
Q4 2011Distribution of Facilities With Percentage of Participants With Hemoglobin < 10 g/dL Over Time10%-<15% of participants with hemoglobin <10 g/dL16.7 percentage of facilities
Q4 2011Distribution of Facilities With Percentage of Participants With Hemoglobin < 10 g/dL Over Time15%-<20% of participants with hemoglobin <10 g/dL16.7 percentage of facilities
Q4 2011Distribution of Facilities With Percentage of Participants With Hemoglobin < 10 g/dL Over Time0%-<5% of participants with hemoglobin < 10 g/dL6.3 percentage of facilities 1.21
Q4 2011Distribution of Facilities With Percentage of Participants With Hemoglobin < 10 g/dL Over Time≥20% of participants with hemoglobin <10 g/dL52.1 percentage of facilities
Q4 2011Distribution of Facilities With Percentage of Participants With Hemoglobin < 10 g/dL Over Time5%-<10% of participants with hemoglobin <10 g/dL8.3 percentage of facilities
Secondary

Mean Hemoglobin Concentration by Quarter

Time frame: 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.

ArmMeasureValue (MEAN)Dispersion
CohortMean Hemoglobin Concentration by Quarter11.28 g/dLStandard Deviation 1.35
Q1 2011Mean Hemoglobin Concentration by Quarter11.17 g/dLStandard Deviation 1.35
Q2 2011Mean Hemoglobin Concentration by Quarter11.06 g/dLStandard Deviation 1.25
Q3 2011Mean Hemoglobin Concentration by Quarter11.00 g/dLStandard Deviation 1.32
Q4 2011Mean Hemoglobin Concentration by Quarter10.78 g/dLStandard Deviation 1.22
Secondary

Number of Participants Taking Epoetin Alfa by Month

The number of participants who took epoetin alfa only, by month, in participants on hemodialysis.

Time frame: December 2010, March 2011, June 2011, September 2011, December 2011

Population: Primary Analysis Set participants on study and on hemodialysis at each time point.

ArmMeasureValue (NUMBER)Dispersion
CohortNumber of Participants Taking Epoetin Alfa by Month1269 participants 57684.5
Q1 2011Number of Participants Taking Epoetin Alfa by Month1299 participants 52423.4
Q2 2011Number of Participants Taking Epoetin Alfa by Month1244 participants 51344.7
Q3 2011Number of Participants Taking Epoetin Alfa by Month1212 participants 48175.3
Q4 2011Number of Participants Taking Epoetin Alfa by Month1140 participants 47792.1
Secondary

Number of Participants With Transfusions, Hospitalizations, Mortality, and Transfers Out

Time frame: June to December 2010, Q1 2011, Q2 2011, Q3 2011, and Q4 2011.

Population: Primary Analysis Set participants on study at each time point

ArmMeasureGroupValue (NUMBER)
CohortNumber of Participants With Transfusions, Hospitalizations, Mortality, and Transfers OutParticipants who died71 participants
CohortNumber of Participants With Transfusions, Hospitalizations, Mortality, and Transfers OutParticipants with hospitalizations574 participants
CohortNumber of Participants With Transfusions, Hospitalizations, Mortality, and Transfers OutParticipants with transfusions54 participants
CohortNumber of Participants With Transfusions, Hospitalizations, Mortality, and Transfers OutParticipants who transferred out63 participants
Q1 2011Number of Participants With Transfusions, Hospitalizations, Mortality, and Transfers OutParticipants who died67 participants
Q1 2011Number of Participants With Transfusions, Hospitalizations, Mortality, and Transfers OutParticipants with transfusions56 participants
Q1 2011Number of Participants With Transfusions, Hospitalizations, Mortality, and Transfers OutParticipants who transferred out51 participants
Q1 2011Number of Participants With Transfusions, Hospitalizations, Mortality, and Transfers OutParticipants with hospitalizations445 participants
Q2 2011Number of Participants With Transfusions, Hospitalizations, Mortality, and Transfers OutParticipants with transfusions50 participants
Q2 2011Number of Participants With Transfusions, Hospitalizations, Mortality, and Transfers OutParticipants who died52 participants
Q2 2011Number of Participants With Transfusions, Hospitalizations, Mortality, and Transfers OutParticipants who transferred out31 participants
Q2 2011Number of Participants With Transfusions, Hospitalizations, Mortality, and Transfers OutParticipants with hospitalizations354 participants
Q3 2011Number of Participants With Transfusions, Hospitalizations, Mortality, and Transfers OutParticipants who transferred out47 participants
Q3 2011Number of Participants With Transfusions, Hospitalizations, Mortality, and Transfers OutParticipants with hospitalizations296 participants
Q3 2011Number of Participants With Transfusions, Hospitalizations, Mortality, and Transfers OutParticipants who died55 participants
Q3 2011Number of Participants With Transfusions, Hospitalizations, Mortality, and Transfers OutParticipants with transfusions39 participants
Q4 2011Number of Participants With Transfusions, Hospitalizations, Mortality, and Transfers OutParticipants who transferred out21 participants
Q4 2011Number of Participants With Transfusions, Hospitalizations, Mortality, and Transfers OutParticipants with transfusions36 participants
Q4 2011Number of Participants With Transfusions, Hospitalizations, Mortality, and Transfers OutParticipants with hospitalizations275 participants
Q4 2011Number of Participants With Transfusions, Hospitalizations, Mortality, and Transfers OutParticipants who died46 participants
Secondary

Percentage of Participants in Each Vascular Access Type Category

The percentage of participants in each vascular access type category out of all enrolled participants on hemodialysis over the course of the study.

Time frame: 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

ArmMeasureGroupValue (NUMBER)
CohortPercentage of Participants in Each Vascular Access Type CategoryVenous catheter19.9 percentage of participants
CohortPercentage of Participants in Each Vascular Access Type CategoryArteriovenous fistula62.8 percentage of participants
CohortPercentage of Participants in Each Vascular Access Type CategoryArteriovenous graft17.2 percentage of participants
CohortPercentage of Participants in Each Vascular Access Type CategoryMissing0.1 percentage of participants
Q1 2011Percentage of Participants in Each Vascular Access Type CategoryArteriovenous graft16.8 percentage of participants
Q1 2011Percentage of Participants in Each Vascular Access Type CategoryArteriovenous fistula63.2 percentage of participants
Q1 2011Percentage of Participants in Each Vascular Access Type CategoryVenous catheter20.0 percentage of participants
Q1 2011Percentage of Participants in Each Vascular Access Type CategoryMissing0.1 percentage of participants
Q2 2011Percentage of Participants in Each Vascular Access Type CategoryArteriovenous fistula63.5 percentage of participants
Q2 2011Percentage of Participants in Each Vascular Access Type CategoryMissing0.1 percentage of participants
Q2 2011Percentage of Participants in Each Vascular Access Type CategoryArteriovenous graft16.2 percentage of participants
Q2 2011Percentage of Participants in Each Vascular Access Type CategoryVenous catheter20.2 percentage of participants
Q3 2011Percentage of Participants in Each Vascular Access Type CategoryArteriovenous fistula63.8 percentage of participants
Q3 2011Percentage of Participants in Each Vascular Access Type CategoryMissing0.1 percentage of participants
Q3 2011Percentage of Participants in Each Vascular Access Type CategoryVenous catheter20.1 percentage of participants
Q3 2011Percentage of Participants in Each Vascular Access Type CategoryArteriovenous graft16.0 percentage of participants
Q4 2011Percentage of Participants in Each Vascular Access Type CategoryArteriovenous graft15.5 percentage of participants
Q4 2011Percentage of Participants in Each Vascular Access Type CategoryArteriovenous fistula63.7 percentage of participants
Q4 2011Percentage of Participants in Each Vascular Access Type CategoryMissing0.1 percentage of participants
Q4 2011Percentage of Participants in Each Vascular Access Type CategoryVenous catheter20.7 percentage of participants
Secondary

Percentage of Participants Per Facility Receiving Erythropoietin Stimulation Agents (ESA)

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.

Time frame: 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.

ArmMeasureValue (MEAN)
CohortPercentage of Participants Per Facility Receiving Erythropoietin Stimulation Agents (ESA)91.2 percentage of participants per facility
Q1 2011Percentage of Participants Per Facility Receiving Erythropoietin Stimulation Agents (ESA)92.0 percentage of participants per facility
Q2 2011Percentage of Participants Per Facility Receiving Erythropoietin Stimulation Agents (ESA)90.9 percentage of participants per facility
Q3 2011Percentage of Participants Per Facility Receiving Erythropoietin Stimulation Agents (ESA)91.2 percentage of participants per facility
Q4 2011Percentage of Participants Per Facility Receiving Erythropoietin Stimulation Agents (ESA)89.4 percentage of participants per facility
Secondary

Percentage of Participants Per Facility With Transferrin Saturation < 20% and Ferritin Level < 100 ng/mL

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.

Time frame: December 2010, March 2011, June 2011, September 2011, December 2011

Population: Facilities / participants with at least one non-missing transferrin saturation or ferritin record at each time point.

ArmMeasureValue (MEAN)Dispersion
CohortPercentage of Participants Per Facility With Transferrin Saturation < 20% and Ferritin Level < 100 ng/mL2.4 percentage of participants per facility95% Confidence Interval 1.36
Q1 2011Percentage of Participants Per Facility With Transferrin Saturation < 20% and Ferritin Level < 100 ng/mL0.6 percentage of participants per facility95% Confidence Interval 1.33
Q2 2011Percentage of Participants Per Facility With Transferrin Saturation < 20% and Ferritin Level < 100 ng/mL1.4 percentage of participants per facility95% Confidence Interval 1.23
Q3 2011Percentage of Participants Per Facility With Transferrin Saturation < 20% and Ferritin Level < 100 ng/mL1.0 percentage of participants per facility95% Confidence Interval 1.29
Q4 2011Percentage of Participants Per Facility With Transferrin Saturation < 20% and Ferritin Level < 100 ng/mL0.7 percentage of participants per facility95% Confidence Interval 1.21
Secondary

Percentage of Participants Receiving a Vitamin D Sterol

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.

Time frame: Fourth quarter (Q4) 2010, Q1 2011, Q2 2011, Q3 2011, and Q4 2011.

Population: Primary Analysis Set participants on study at each time point

ArmMeasureGroupValue (NUMBER)
CohortPercentage of Participants Receiving a Vitamin D SterolOral - activated7.6 percentage of participants
CohortPercentage of Participants Receiving a Vitamin D SterolIntravenous76.0 percentage of participants
CohortPercentage of Participants Receiving a Vitamin D SterolOral - not activated2.3 percentage of participants
CohortPercentage of Participants Receiving a Vitamin D SterolAny Vitamin D sterol80.6 percentage of participants
Q1 2011Percentage of Participants Receiving a Vitamin D SterolIntravenous68.0 percentage of participants
Q1 2011Percentage of Participants Receiving a Vitamin D SterolAny Vitamin D sterol76.2 percentage of participants
Q1 2011Percentage of Participants Receiving a Vitamin D SterolOral - not activated5.9 percentage of participants
Q1 2011Percentage of Participants Receiving a Vitamin D SterolOral - activated10.3 percentage of participants
Q2 2011Percentage of Participants Receiving a Vitamin D SterolIntravenous66.5 percentage of participants
Q2 2011Percentage of Participants Receiving a Vitamin D SterolAny Vitamin D sterol77.5 percentage of participants
Q2 2011Percentage of Participants Receiving a Vitamin D SterolOral - activated15.3 percentage of participants
Q2 2011Percentage of Participants Receiving a Vitamin D SterolOral - not activated6.7 percentage of participants
Q3 2011Percentage of Participants Receiving a Vitamin D SterolAny Vitamin D sterol77.7 percentage of participants
Q3 2011Percentage of Participants Receiving a Vitamin D SterolOral - not activated9.1 percentage of participants
Q3 2011Percentage of Participants Receiving a Vitamin D SterolIntravenous62.6 percentage of participants
Q3 2011Percentage of Participants Receiving a Vitamin D SterolOral - activated16.2 percentage of participants
Q4 2011Percentage of Participants Receiving a Vitamin D SterolAny Vitamin D sterol79.4 percentage of participants
Q4 2011Percentage of Participants Receiving a Vitamin D SterolOral - not activated9.7 percentage of participants
Q4 2011Percentage of Participants Receiving a Vitamin D SterolOral - activated17.7 percentage of participants
Q4 2011Percentage of Participants Receiving a Vitamin D SterolIntravenous62.7 percentage of participants
Secondary

Percentage of Participants Receiving Cinacalcet

The percentage of participants receiving cinacalcet (Sensipar) over time

Time frame: Fourth quarter (Q4) 2010, Q1 2011, Q2 2011, Q3 2011, and Q4 2011.

Population: Primary Analysis Set participants on study at each time point

ArmMeasureValue (NUMBER)
CohortPercentage of Participants Receiving Cinacalcet22.3 percentage of participants
Q1 2011Percentage of Participants Receiving Cinacalcet26.2 percentage of participants
Q2 2011Percentage of Participants Receiving Cinacalcet29.3 percentage of participants
Q3 2011Percentage of Participants Receiving Cinacalcet30.0 percentage of participants
Q4 2011Percentage of Participants Receiving Cinacalcet31.0 percentage of participants
Secondary

Percentage of Participants Receiving Phosphate Binding Agents

The percentage of participants receiving phosphate binding agents over time

Time frame: Fourth quarter (Q4) 2010, Q1 2011, Q2 2011, Q3 2011, and Q4 2011.

Population: Primary Analysis Set participants on study at each time point

ArmMeasureValue (NUMBER)
CohortPercentage of Participants Receiving Phosphate Binding Agents60.9 percentage of participants
Q1 2011Percentage of Participants Receiving Phosphate Binding Agents66.0 percentage of participants
Q2 2011Percentage of Participants Receiving Phosphate Binding Agents70.4 percentage of participants
Q3 2011Percentage of Participants Receiving Phosphate Binding Agents74.2 percentage of participants
Q4 2011Percentage of Participants Receiving Phosphate Binding Agents73.3 percentage of participants
Secondary

Percentage of Participants Treated by Each Dialysis Modality

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.

Time frame: Fourth quarter (Q4) 2010, Q1 2011, Q2 2011, Q3 2011, and Q4 2011.

Population: Primary Analysis Set participants on study at each time point

ArmMeasureGroupValue (NUMBER)
CohortPercentage of Participants Treated by Each Dialysis ModalityPeritoneal2.0 percentage of participants
CohortPercentage of Participants Treated by Each Dialysis ModalityMissing3.0 percentage of participants
CohortPercentage of Participants Treated by Each Dialysis ModalityHome hemodialysis0.5 percentage of participants
CohortPercentage of Participants Treated by Each Dialysis ModalityHemodialysis (in center)94.4 percentage of participants
Q1 2011Percentage of Participants Treated by Each Dialysis ModalityMissing4.2 percentage of participants
Q1 2011Percentage of Participants Treated by Each Dialysis ModalityHemodialysis (in center)93.0 percentage of participants
Q1 2011Percentage of Participants Treated by Each Dialysis ModalityPeritoneal2.2 percentage of participants
Q1 2011Percentage of Participants Treated by Each Dialysis ModalityHome hemodialysis0.7 percentage of participants
Q2 2011Percentage of Participants Treated by Each Dialysis ModalityHome hemodialysis0.6 percentage of participants
Q2 2011Percentage of Participants Treated by Each Dialysis ModalityPeritoneal3.6 percentage of participants
Q2 2011Percentage of Participants Treated by Each Dialysis ModalityMissing2.8 percentage of participants
Q2 2011Percentage of Participants Treated by Each Dialysis ModalityHemodialysis (in center)93.0 percentage of participants
Q3 2011Percentage of Participants Treated by Each Dialysis ModalityHome hemodialysis0.7 percentage of participants
Q3 2011Percentage of Participants Treated by Each Dialysis ModalityHemodialysis (in center)92.6 percentage of participants
Q3 2011Percentage of Participants Treated by Each Dialysis ModalityPeritoneal2.8 percentage of participants
Q3 2011Percentage of Participants Treated by Each Dialysis ModalityMissing3.9 percentage of participants
Q4 2011Percentage of Participants Treated by Each Dialysis ModalityMissing3.5 percentage of participants
Q4 2011Percentage of Participants Treated by Each Dialysis ModalityPeritoneal2.9 percentage of participants
Q4 2011Percentage of Participants Treated by Each Dialysis ModalityHemodialysis (in center)93.0 percentage of participants
Q4 2011Percentage of Participants Treated by Each Dialysis ModalityHome hemodialysis0.6 percentage of participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026