Chronic Kidney Disease
Conditions
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
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Per Facility With Hemoglobin < 10 g/dL | Data were collected monthly from June 2010 until September 2012 | 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. |
| Percentage of Participants Per Facility With Hemoglobin > 12 g/dL | Data were collected monthly from June 2010 until September 2012 | 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. |
| Percentage of Participants Per Facility With Urea Reduction Ratio (URR) ≥ 65% | Data were collected monthly from June 2010 until September 2012 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Receiving Cinacalcet | Fourth 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 Agents | Fourth 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 Sterol | Fourth 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 Quarter | Fourth quarter (Q4) 2010, Q1 2011, Q2 2011, Q3 2011, and Q4 2011. | — |
| Percentage of Participants Treated by Each Dialysis Modality | Fourth 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/mL | December 2010, March 2011, June 2011, September 2011, December 2011 | 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. |
| Cumulative Monthly Dose of Epoetin Alfa Administered | December 2010, March 2011, June 2011, September 2011, December 2011 | The cumulative monthly intravenous epoetin alfa dose in participants on hemodialysis. |
| Number of Participants Taking Epoetin Alfa by Month | December 2010, March 2011, June 2011, September 2011, December 2011 | The number of participants who took epoetin alfa only, by month, in participants on hemodialysis. |
| Number of Participants With Transfusions, Hospitalizations, Mortality, and Transfers Out | June 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 Time | December 2010, March 2011, June 2011, September 2011, December 2011 | 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. |
| Percentage of Participants in Each Vascular Access Type Category | Fourth 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
| Arm | Count |
|---|---|
| Cohort Patients with end-stage renal disease (ESRD) treated at small dialysis organizations (SDOs). | 2,248 |
| Total | 2,248 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 439 |
| Overall Study | Ineligibility determined | 6 |
| Overall Study | Lost to Follow-up | 11 |
| Overall Study | Other | 40 |
| Overall Study | Physician Decision | 2 |
| Overall Study | Protocol deviation | 6 |
| Overall Study | Protocol-specified criteria | 551 |
| Overall Study | Withdrawal by Subject | 11 |
Baseline characteristics
| Characteristic | Cohort |
|---|---|
| Age, Continuous | 61.1 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 type | EG000 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
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).
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Cohort | Percentage of Participants Per Facility With Hemoglobin < 10 g/dL | June 2011 (n=50) | 16.7 percentage of participants per facility |
| Cohort | Percentage of Participants Per Facility With Hemoglobin < 10 g/dL | July 2011 (n=50) | 14.0 percentage of participants per facility |
| Cohort | Percentage of Participants Per Facility With Hemoglobin < 10 g/dL | August 2011 (n=50) | 15.5 percentage of participants per facility |
| Cohort | Percentage of Participants Per Facility With Hemoglobin < 10 g/dL | September 2011 (n=50) | 19.3 percentage of participants per facility |
| Cohort | Percentage of Participants Per Facility With Hemoglobin < 10 g/dL | October 2011 (n=50) | 21.7 percentage of participants per facility |
| Cohort | Percentage of Participants Per Facility With Hemoglobin < 10 g/dL | November 2011 (n=50) | 22.2 percentage of participants per facility |
| Cohort | Percentage of Participants Per Facility With Hemoglobin < 10 g/dL | December 2011 (n=48) | 21.8 percentage of participants per facility |
| Cohort | Percentage of Participants Per Facility With Hemoglobin < 10 g/dL | January 2012 (n=48) | 22.0 percentage of participants per facility |
| Cohort | Percentage of Participants Per Facility With Hemoglobin < 10 g/dL | February 2012 (n=48) | 19.5 percentage of participants per facility |
| Cohort | Percentage of Participants Per Facility With Hemoglobin < 10 g/dL | March 2012 (n=48) | 23.3 percentage of participants per facility |
| Cohort | Percentage of Participants Per Facility With Hemoglobin < 10 g/dL | April 2012 (n=48) | 24.0 percentage of participants per facility |
| Cohort | Percentage of Participants Per Facility With Hemoglobin < 10 g/dL | May 2012 (n=48) | 25.1 percentage of participants per facility |
| Cohort | Percentage of Participants Per Facility With Hemoglobin < 10 g/dL | June 2012 (n=45) | 24.6 percentage of participants per facility |
| Cohort | Percentage of Participants Per Facility With Hemoglobin < 10 g/dL | July 2012 (n=45) | 23.1 percentage of participants per facility |
| Cohort | Percentage of Participants Per Facility With Hemoglobin < 10 g/dL | August 2012 (n=45) | 22.6 percentage of participants per facility |
| Cohort | Percentage of Participants Per Facility With Hemoglobin < 10 g/dL | September 2012 (n=45) | 22.2 percentage of participants per facility |
| Cohort | Percentage of Participants Per Facility With Hemoglobin < 10 g/dL | June 2010 (n=39) | 11.5 percentage of participants per facility |
| Cohort | Percentage of Participants Per Facility With Hemoglobin < 10 g/dL | July 2010 (n=45) | 11.0 percentage of participants per facility |
| Cohort | Percentage of Participants Per Facility With Hemoglobin < 10 g/dL | August 2010 (n=50) | 13.1 percentage of participants per facility |
| Cohort | Percentage of Participants Per Facility With Hemoglobin < 10 g/dL | September 2010 (n=51) | 12.0 percentage of participants per facility |
| Cohort | Percentage of Participants Per Facility With Hemoglobin < 10 g/dL | October 2010 (n=51) | 12.7 percentage of participants per facility |
| Cohort | Percentage of Participants Per Facility With Hemoglobin < 10 g/dL | November 2010 (n=51) | 13.2 percentage of participants per facility |
| Cohort | Percentage of Participants Per Facility With Hemoglobin < 10 g/dL | December 2010 (n=51) | 14.3 percentage of participants per facility |
| Cohort | Percentage of Participants Per Facility With Hemoglobin < 10 g/dL | January 2011 (n=50) | 13.5 percentage of participants per facility |
| Cohort | Percentage of Participants Per Facility With Hemoglobin < 10 g/dL | February 2011 (n=50) | 18.3 percentage of participants per facility |
| Cohort | Percentage of Participants Per Facility With Hemoglobin < 10 g/dL | March 2011 (n=50) | 16.4 percentage of participants per facility |
| Cohort | Percentage of Participants Per Facility With Hemoglobin < 10 g/dL | April 2011 (n=50) | 16.9 percentage of participants per facility |
| Cohort | Percentage of Participants Per Facility With Hemoglobin < 10 g/dL | May 2011 (n=50) | 15.4 percentage of participants per facility |
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).
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Cohort | Percentage of Participants Per Facility With Hemoglobin > 12 g/dL | June 2010 (n=39) | 30.2 percentage of participants per facility |
| Cohort | Percentage of Participants Per Facility With Hemoglobin > 12 g/dL | July 2010 (n=45) | 28.3 percentage of participants per facility |
| Cohort | Percentage of Participants Per Facility With Hemoglobin > 12 g/dL | August 2010 (n=50) | 28.2 percentage of participants per facility |
| Cohort | Percentage of Participants Per Facility With Hemoglobin > 12 g/dL | September 2010 (n=51) | 30.6 percentage of participants per facility |
| Cohort | Percentage of Participants Per Facility With Hemoglobin > 12 g/dL | October 2010 (n=51) | 28.7 percentage of participants per facility |
| Cohort | Percentage of Participants Per Facility With Hemoglobin > 12 g/dL | November 2010 (n=51) | 27.8 percentage of participants per facility |
| Cohort | Percentage of Participants Per Facility With Hemoglobin > 12 g/dL | December 2010 (n=51) | 24.5 percentage of participants per facility |
| Cohort | Percentage of Participants Per Facility With Hemoglobin > 12 g/dL | January 2011 (n=50) | 25.6 percentage of participants per facility |
| Cohort | Percentage of Participants Per Facility With Hemoglobin > 12 g/dL | February 2011 (n=50) | 24.5 percentage of participants per facility |
| Cohort | Percentage of Participants Per Facility With Hemoglobin > 12 g/dL | March 2011 (n=50) | 22.8 percentage of participants per facility |
| Cohort | Percentage of Participants Per Facility With Hemoglobin > 12 g/dL | April 2011 (n=50) | 21.8 percentage of participants per facility |
| Cohort | Percentage of Participants Per Facility With Hemoglobin > 12 g/dL | May 2011 (n=50) | 23.2 percentage of participants per facility |
| Cohort | Percentage of Participants Per Facility With Hemoglobin > 12 g/dL | June 2011 (n=50) | 18.5 percentage of participants per facility |
| Cohort | Percentage of Participants Per Facility With Hemoglobin > 12 g/dL | July 2011 (n=50) | 20.2 percentage of participants per facility |
| Cohort | Percentage of Participants Per Facility With Hemoglobin > 12 g/dL | August 2011 (n=50) | 19.0 percentage of participants per facility |
| Cohort | Percentage of Participants Per Facility With Hemoglobin > 12 g/dL | September 2011 (n=50) | 18.2 percentage of participants per facility |
| Cohort | Percentage of Participants Per Facility With Hemoglobin > 12 g/dL | October 2011 (n=50) | 14.3 percentage of participants per facility |
| Cohort | Percentage of Participants Per Facility With Hemoglobin > 12 g/dL | November 2011 (n=50) | 11.5 percentage of participants per facility |
| Cohort | Percentage of Participants Per Facility With Hemoglobin > 12 g/dL | December 2011 (n=48) | 11.8 percentage of participants per facility |
| Cohort | Percentage of Participants Per Facility With Hemoglobin > 12 g/dL | January 2012 (n=48) | 13.7 percentage of participants per facility |
| Cohort | Percentage of Participants Per Facility With Hemoglobin > 12 g/dL | February 2012 (n=48) | 12.5 percentage of participants per facility |
| Cohort | Percentage of Participants Per Facility With Hemoglobin > 12 g/dL | March 2012 (n=48) | 11.2 percentage of participants per facility |
| Cohort | Percentage of Participants Per Facility With Hemoglobin > 12 g/dL | April 2012 (n=48) | 10.3 percentage of participants per facility |
| Cohort | Percentage of Participants Per Facility With Hemoglobin > 12 g/dL | May 2012 (n=48) | 11.6 percentage of participants per facility |
| Cohort | Percentage of Participants Per Facility With Hemoglobin > 12 g/dL | June 2012 (n=45) | 12.1 percentage of participants per facility |
| Cohort | Percentage of Participants Per Facility With Hemoglobin > 12 g/dL | July 2012 (n=45) | 11.9 percentage of participants per facility |
| Cohort | Percentage of Participants Per Facility With Hemoglobin > 12 g/dL | August 2012 (n=45) | 11.6 percentage of participants per facility |
| Cohort | Percentage of Participants Per Facility With Hemoglobin > 12 g/dL | September 2012 (n=45) | 13.1 percentage of participants per facility |
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).
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Cohort | Percentage of Participants Per Facility With Urea Reduction Ratio (URR) ≥ 65% | June 2010 (n=37) | 84.8 percentage of participants per facility |
| Cohort | Percentage of Participants Per Facility With Urea Reduction Ratio (URR) ≥ 65% | July 2010 (n=44) | 85.0 percentage of participants per facility |
| Cohort | Percentage of Participants Per Facility With Urea Reduction Ratio (URR) ≥ 65% | August 2010 (n=49) | 85.0 percentage of participants per facility |
| Cohort | Percentage of Participants Per Facility With Urea Reduction Ratio (URR) ≥ 65% | September 2010 (n=50) | 86.9 percentage of participants per facility |
| Cohort | Percentage of Participants Per Facility With Urea Reduction Ratio (URR) ≥ 65% | October 2010 (n=50) | 87.9 percentage of participants per facility |
| Cohort | Percentage of Participants Per Facility With Urea Reduction Ratio (URR) ≥ 65% | November 2010 (n=50) | 87.8 percentage of participants per facility |
| Cohort | Percentage of Participants Per Facility With Urea Reduction Ratio (URR) ≥ 65% | December 2010 (n=50) | 86.9 percentage of participants per facility |
| Cohort | Percentage of Participants Per Facility With Urea Reduction Ratio (URR) ≥ 65% | January 2011 (n=49) | 85.5 percentage of participants per facility |
| Cohort | Percentage of Participants Per Facility With Urea Reduction Ratio (URR) ≥ 65% | February 2011 (n=49) | 86.7 percentage of participants per facility |
| Cohort | Percentage of Participants Per Facility With Urea Reduction Ratio (URR) ≥ 65% | March 2011 (n=49) | 88.4 percentage of participants per facility |
| Cohort | Percentage of Participants Per Facility With Urea Reduction Ratio (URR) ≥ 65% | April 2011 (n=49) | 87.8 percentage of participants per facility |
| Cohort | Percentage of Participants Per Facility With Urea Reduction Ratio (URR) ≥ 65% | May 2011 (n=49) | 88.8 percentage of participants per facility |
| Cohort | Percentage of Participants Per Facility With Urea Reduction Ratio (URR) ≥ 65% | June 2011 (n=49) | 90.2 percentage of participants per facility |
| Cohort | Percentage of Participants Per Facility With Urea Reduction Ratio (URR) ≥ 65% | July 2011 (n=49) | 89.0 percentage of participants per facility |
| Cohort | Percentage of Participants Per Facility With Urea Reduction Ratio (URR) ≥ 65% | August 2011 (n=49) | 89.0 percentage of participants per facility |
| Cohort | Percentage of Participants Per Facility With Urea Reduction Ratio (URR) ≥ 65% | September 2011 (n=49) | 89.5 percentage of participants per facility |
| Cohort | Percentage of Participants Per Facility With Urea Reduction Ratio (URR) ≥ 65% | October 2011 (n=49) | 90.4 percentage of participants per facility |
| Cohort | Percentage of Participants Per Facility With Urea Reduction Ratio (URR) ≥ 65% | November 2011 (n=49) | 89.2 percentage of participants per facility |
| Cohort | Percentage of Participants Per Facility With Urea Reduction Ratio (URR) ≥ 65% | December 2011 (n=47) | 90.3 percentage of participants per facility |
| Cohort | Percentage of Participants Per Facility With Urea Reduction Ratio (URR) ≥ 65% | January 2012 (n=47) | 88.7 percentage of participants per facility |
| Cohort | Percentage of Participants Per Facility With Urea Reduction Ratio (URR) ≥ 65% | February 2012 (n=47) | 89.3 percentage of participants per facility |
| Cohort | Percentage of Participants Per Facility With Urea Reduction Ratio (URR) ≥ 65% | March 2012 (n=48) | 89.4 percentage of participants per facility |
| Cohort | Percentage of Participants Per Facility With Urea Reduction Ratio (URR) ≥ 65% | April 2012 (n=47) | 90.9 percentage of participants per facility |
| Cohort | Percentage of Participants Per Facility With Urea Reduction Ratio (URR) ≥ 65% | May 2012 (n=47) | 91.1 percentage of participants per facility |
| Cohort | Percentage of Participants Per Facility With Urea Reduction Ratio (URR) ≥ 65% | June 2012 (n=44) | 91.1 percentage of participants per facility |
| Cohort | Percentage of Participants Per Facility With Urea Reduction Ratio (URR) ≥ 65% | July 2012 (n=44) | 91.3 percentage of participants per facility |
| Cohort | Percentage of Participants Per Facility With Urea Reduction Ratio (URR) ≥ 65% | August 2012 (n=44) | 91.4 percentage of participants per facility |
| Cohort | Percentage of Participants Per Facility With Urea Reduction Ratio (URR) ≥ 65% | September 2012 (n=44) | 93.3 percentage of participants per facility |
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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cohort | Cumulative Monthly Dose of Epoetin Alfa Administered | 39000.0 units |
| Q1 2011 | Cumulative Monthly Dose of Epoetin Alfa Administered | 35000.0 units |
| Q2 2011 | Cumulative Monthly Dose of Epoetin Alfa Administered | 33800.0 units |
| Q3 2011 | Cumulative Monthly Dose of Epoetin Alfa Administered | 28000.0 units |
| Q4 2011 | Cumulative Monthly Dose of Epoetin Alfa Administered | 32900.0 units |
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.
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Cohort | 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 | — |
| Cohort | 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 |
| Cohort | 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 | — |
| Cohort | 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 | — |
| Cohort | 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 | — |
| Q1 2011 | Distribution of Facilities With Percentage of Participants With Hemoglobin < 10 g/dL Over Time | 15%-<20% of participants with hemoglobin <10 g/dL | 18.0 percentage of facilities | — |
| Q1 2011 | Distribution of Facilities With Percentage of Participants With Hemoglobin < 10 g/dL Over Time | 10%-<15% of participants with hemoglobin <10 g/dL | 24.0 percentage of facilities | — |
| Q1 2011 | Distribution of Facilities With Percentage of Participants With Hemoglobin < 10 g/dL Over Time | 5%-<10% of participants with hemoglobin <10 g/dL | 22.0 percentage of facilities | — |
| Q1 2011 | Distribution of Facilities With Percentage of Participants With Hemoglobin < 10 g/dL Over Time | ≥20% of participants with hemoglobin <10 g/dL | 26.0 percentage of facilities | — |
| Q1 2011 | Distribution of Facilities With Percentage of Participants With Hemoglobin < 10 g/dL Over Time | 0%-<5% of participants with hemoglobin < 10 g/dL | 10.0 percentage of facilities | 1.33 |
| Q2 2011 | Distribution of Facilities With Percentage of Participants With Hemoglobin < 10 g/dL Over Time | 10%-<15% of participants with hemoglobin <10 g/dL | 20.0 percentage of facilities | — |
| Q2 2011 | Distribution of Facilities With Percentage of Participants With Hemoglobin < 10 g/dL Over Time | 0%-<5% of participants with hemoglobin < 10 g/dL | 10.0 percentage of facilities | 1.23 |
| Q2 2011 | Distribution of Facilities With Percentage of Participants With Hemoglobin < 10 g/dL Over Time | 5%-<10% of participants with hemoglobin <10 g/dL | 20.0 percentage of facilities | — |
| Q2 2011 | Distribution of Facilities With Percentage of Participants With Hemoglobin < 10 g/dL Over Time | 15%-<20% of participants with hemoglobin <10 g/dL | 10.0 percentage of facilities | — |
| Q2 2011 | Distribution of Facilities With Percentage of Participants With Hemoglobin < 10 g/dL Over Time | ≥20% of participants with hemoglobin <10 g/dL | 40.0 percentage of facilities | — |
| Q3 2011 | Distribution of Facilities With Percentage of Participants With Hemoglobin < 10 g/dL Over Time | ≥20% of participants with hemoglobin <10 g/dL | 42.0 percentage of facilities | — |
| Q3 2011 | Distribution of Facilities With Percentage of Participants With Hemoglobin < 10 g/dL Over Time | 0%-<5% of participants with hemoglobin < 10 g/dL | 4.0 percentage of facilities | 1.29 |
| Q3 2011 | Distribution of Facilities With Percentage of Participants With Hemoglobin < 10 g/dL Over Time | 15%-<20% of participants with hemoglobin <10 g/dL | 20.0 percentage of facilities | — |
| Q3 2011 | Distribution of Facilities With Percentage of Participants With Hemoglobin < 10 g/dL Over Time | 10%-<15% of participants with hemoglobin <10 g/dL | 18.0 percentage of facilities | — |
| Q3 2011 | Distribution of Facilities With Percentage of Participants With Hemoglobin < 10 g/dL Over Time | 5%-<10% of participants with hemoglobin <10 g/dL | 16.0 percentage of facilities | — |
| Q4 2011 | Distribution of Facilities With Percentage of Participants With Hemoglobin < 10 g/dL Over Time | 10%-<15% of participants with hemoglobin <10 g/dL | 16.7 percentage of facilities | — |
| Q4 2011 | Distribution of Facilities With Percentage of Participants With Hemoglobin < 10 g/dL Over Time | 15%-<20% of participants with hemoglobin <10 g/dL | 16.7 percentage of facilities | — |
| Q4 2011 | Distribution of Facilities With Percentage of Participants With Hemoglobin < 10 g/dL Over Time | 0%-<5% of participants with hemoglobin < 10 g/dL | 6.3 percentage of facilities | 1.21 |
| Q4 2011 | Distribution of Facilities With Percentage of Participants With Hemoglobin < 10 g/dL Over Time | ≥20% of participants with hemoglobin <10 g/dL | 52.1 percentage of facilities | — |
| Q4 2011 | Distribution of Facilities With Percentage of Participants With Hemoglobin < 10 g/dL Over Time | 5%-<10% of participants with hemoglobin <10 g/dL | 8.3 percentage of facilities | — |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort | Mean Hemoglobin Concentration by Quarter | 11.28 g/dL | Standard Deviation 1.35 |
| Q1 2011 | Mean Hemoglobin Concentration by Quarter | 11.17 g/dL | Standard Deviation 1.35 |
| Q2 2011 | Mean Hemoglobin Concentration by Quarter | 11.06 g/dL | Standard Deviation 1.25 |
| Q3 2011 | Mean Hemoglobin Concentration by Quarter | 11.00 g/dL | Standard Deviation 1.32 |
| Q4 2011 | Mean Hemoglobin Concentration by Quarter | 10.78 g/dL | Standard Deviation 1.22 |
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.
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Cohort | Number of Participants Taking Epoetin Alfa by Month | 1269 participants | 57684.5 |
| Q1 2011 | Number of Participants Taking Epoetin Alfa by Month | 1299 participants | 52423.4 |
| Q2 2011 | Number of Participants Taking Epoetin Alfa by Month | 1244 participants | 51344.7 |
| Q3 2011 | Number of Participants Taking Epoetin Alfa by Month | 1212 participants | 48175.3 |
| Q4 2011 | Number of Participants Taking Epoetin Alfa by Month | 1140 participants | 47792.1 |
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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort | Number of Participants With Transfusions, Hospitalizations, Mortality, and Transfers Out | Participants who died | 71 participants |
| Cohort | Number of Participants With Transfusions, Hospitalizations, Mortality, and Transfers Out | Participants with hospitalizations | 574 participants |
| Cohort | Number of Participants With Transfusions, Hospitalizations, Mortality, and Transfers Out | Participants with transfusions | 54 participants |
| Cohort | Number of Participants With Transfusions, Hospitalizations, Mortality, and Transfers Out | Participants who transferred out | 63 participants |
| Q1 2011 | Number of Participants With Transfusions, Hospitalizations, Mortality, and Transfers Out | Participants who died | 67 participants |
| Q1 2011 | Number of Participants With Transfusions, Hospitalizations, Mortality, and Transfers Out | Participants with transfusions | 56 participants |
| Q1 2011 | Number of Participants With Transfusions, Hospitalizations, Mortality, and Transfers Out | Participants who transferred out | 51 participants |
| Q1 2011 | Number of Participants With Transfusions, Hospitalizations, Mortality, and Transfers Out | Participants with hospitalizations | 445 participants |
| Q2 2011 | Number of Participants With Transfusions, Hospitalizations, Mortality, and Transfers Out | Participants with transfusions | 50 participants |
| Q2 2011 | Number of Participants With Transfusions, Hospitalizations, Mortality, and Transfers Out | Participants who died | 52 participants |
| Q2 2011 | Number of Participants With Transfusions, Hospitalizations, Mortality, and Transfers Out | Participants who transferred out | 31 participants |
| Q2 2011 | Number of Participants With Transfusions, Hospitalizations, Mortality, and Transfers Out | Participants with hospitalizations | 354 participants |
| Q3 2011 | Number of Participants With Transfusions, Hospitalizations, Mortality, and Transfers Out | Participants who transferred out | 47 participants |
| Q3 2011 | Number of Participants With Transfusions, Hospitalizations, Mortality, and Transfers Out | Participants with hospitalizations | 296 participants |
| Q3 2011 | Number of Participants With Transfusions, Hospitalizations, Mortality, and Transfers Out | Participants who died | 55 participants |
| Q3 2011 | Number of Participants With Transfusions, Hospitalizations, Mortality, and Transfers Out | Participants with transfusions | 39 participants |
| Q4 2011 | Number of Participants With Transfusions, Hospitalizations, Mortality, and Transfers Out | Participants who transferred out | 21 participants |
| Q4 2011 | Number of Participants With Transfusions, Hospitalizations, Mortality, and Transfers Out | Participants with transfusions | 36 participants |
| Q4 2011 | Number of Participants With Transfusions, Hospitalizations, Mortality, and Transfers Out | Participants with hospitalizations | 275 participants |
| Q4 2011 | Number of Participants With Transfusions, Hospitalizations, Mortality, and Transfers Out | Participants who died | 46 participants |
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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort | Percentage of Participants in Each Vascular Access Type Category | Venous catheter | 19.9 percentage of participants |
| Cohort | Percentage of Participants in Each Vascular Access Type Category | Arteriovenous fistula | 62.8 percentage of participants |
| Cohort | Percentage of Participants in Each Vascular Access Type Category | Arteriovenous graft | 17.2 percentage of participants |
| Cohort | Percentage of Participants in Each Vascular Access Type Category | Missing | 0.1 percentage of participants |
| Q1 2011 | Percentage of Participants in Each Vascular Access Type Category | Arteriovenous graft | 16.8 percentage of participants |
| Q1 2011 | Percentage of Participants in Each Vascular Access Type Category | Arteriovenous fistula | 63.2 percentage of participants |
| Q1 2011 | Percentage of Participants in Each Vascular Access Type Category | Venous catheter | 20.0 percentage of participants |
| Q1 2011 | Percentage of Participants in Each Vascular Access Type Category | Missing | 0.1 percentage of participants |
| Q2 2011 | Percentage of Participants in Each Vascular Access Type Category | Arteriovenous fistula | 63.5 percentage of participants |
| Q2 2011 | Percentage of Participants in Each Vascular Access Type Category | Missing | 0.1 percentage of participants |
| Q2 2011 | Percentage of Participants in Each Vascular Access Type Category | Arteriovenous graft | 16.2 percentage of participants |
| Q2 2011 | Percentage of Participants in Each Vascular Access Type Category | Venous catheter | 20.2 percentage of participants |
| Q3 2011 | Percentage of Participants in Each Vascular Access Type Category | Arteriovenous fistula | 63.8 percentage of participants |
| Q3 2011 | Percentage of Participants in Each Vascular Access Type Category | Missing | 0.1 percentage of participants |
| Q3 2011 | Percentage of Participants in Each Vascular Access Type Category | Venous catheter | 20.1 percentage of participants |
| Q3 2011 | Percentage of Participants in Each Vascular Access Type Category | Arteriovenous graft | 16.0 percentage of participants |
| Q4 2011 | Percentage of Participants in Each Vascular Access Type Category | Arteriovenous graft | 15.5 percentage of participants |
| Q4 2011 | Percentage of Participants in Each Vascular Access Type Category | Arteriovenous fistula | 63.7 percentage of participants |
| Q4 2011 | Percentage of Participants in Each Vascular Access Type Category | Missing | 0.1 percentage of participants |
| Q4 2011 | Percentage of Participants in Each Vascular Access Type Category | Venous catheter | 20.7 percentage of participants |
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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Cohort | Percentage of Participants Per Facility Receiving Erythropoietin Stimulation Agents (ESA) | 91.2 percentage of participants per facility |
| Q1 2011 | Percentage of Participants Per Facility Receiving Erythropoietin Stimulation Agents (ESA) | 92.0 percentage of participants per facility |
| Q2 2011 | Percentage of Participants Per Facility Receiving Erythropoietin Stimulation Agents (ESA) | 90.9 percentage of participants per facility |
| Q3 2011 | Percentage of Participants Per Facility Receiving Erythropoietin Stimulation Agents (ESA) | 91.2 percentage of participants per facility |
| Q4 2011 | Percentage of Participants Per Facility Receiving Erythropoietin Stimulation Agents (ESA) | 89.4 percentage of participants per facility |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort | 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 |
| Q1 2011 | Percentage of Participants Per Facility With Transferrin Saturation < 20% and Ferritin Level < 100 ng/mL | 0.6 percentage of participants per facility | 95% Confidence Interval 1.33 |
| Q2 2011 | Percentage of Participants Per Facility With Transferrin Saturation < 20% and Ferritin Level < 100 ng/mL | 1.4 percentage of participants per facility | 95% Confidence Interval 1.23 |
| Q3 2011 | Percentage of Participants Per Facility With Transferrin Saturation < 20% and Ferritin Level < 100 ng/mL | 1.0 percentage of participants per facility | 95% Confidence Interval 1.29 |
| Q4 2011 | Percentage of Participants Per Facility With Transferrin Saturation < 20% and Ferritin Level < 100 ng/mL | 0.7 percentage of participants per facility | 95% Confidence Interval 1.21 |
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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort | Percentage of Participants Receiving a Vitamin D Sterol | Oral - activated | 7.6 percentage of participants |
| Cohort | Percentage of Participants Receiving a Vitamin D Sterol | Intravenous | 76.0 percentage of participants |
| Cohort | Percentage of Participants Receiving a Vitamin D Sterol | Oral - not activated | 2.3 percentage of participants |
| Cohort | Percentage of Participants Receiving a Vitamin D Sterol | Any Vitamin D sterol | 80.6 percentage of participants |
| Q1 2011 | Percentage of Participants Receiving a Vitamin D Sterol | Intravenous | 68.0 percentage of participants |
| Q1 2011 | Percentage of Participants Receiving a Vitamin D Sterol | Any Vitamin D sterol | 76.2 percentage of participants |
| Q1 2011 | Percentage of Participants Receiving a Vitamin D Sterol | Oral - not activated | 5.9 percentage of participants |
| Q1 2011 | Percentage of Participants Receiving a Vitamin D Sterol | Oral - activated | 10.3 percentage of participants |
| Q2 2011 | Percentage of Participants Receiving a Vitamin D Sterol | Intravenous | 66.5 percentage of participants |
| Q2 2011 | Percentage of Participants Receiving a Vitamin D Sterol | Any Vitamin D sterol | 77.5 percentage of participants |
| Q2 2011 | Percentage of Participants Receiving a Vitamin D Sterol | Oral - activated | 15.3 percentage of participants |
| Q2 2011 | Percentage of Participants Receiving a Vitamin D Sterol | Oral - not activated | 6.7 percentage of participants |
| Q3 2011 | Percentage of Participants Receiving a Vitamin D Sterol | Any Vitamin D sterol | 77.7 percentage of participants |
| Q3 2011 | Percentage of Participants Receiving a Vitamin D Sterol | Oral - not activated | 9.1 percentage of participants |
| Q3 2011 | Percentage of Participants Receiving a Vitamin D Sterol | Intravenous | 62.6 percentage of participants |
| Q3 2011 | Percentage of Participants Receiving a Vitamin D Sterol | Oral - activated | 16.2 percentage of participants |
| Q4 2011 | Percentage of Participants Receiving a Vitamin D Sterol | Any Vitamin D sterol | 79.4 percentage of participants |
| Q4 2011 | Percentage of Participants Receiving a Vitamin D Sterol | Oral - not activated | 9.7 percentage of participants |
| Q4 2011 | Percentage of Participants Receiving a Vitamin D Sterol | Oral - activated | 17.7 percentage of participants |
| Q4 2011 | Percentage of Participants Receiving a Vitamin D Sterol | Intravenous | 62.7 percentage of participants |
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort | Percentage of Participants Receiving Cinacalcet | 22.3 percentage of participants |
| Q1 2011 | Percentage of Participants Receiving Cinacalcet | 26.2 percentage of participants |
| Q2 2011 | Percentage of Participants Receiving Cinacalcet | 29.3 percentage of participants |
| Q3 2011 | Percentage of Participants Receiving Cinacalcet | 30.0 percentage of participants |
| Q4 2011 | Percentage of Participants Receiving Cinacalcet | 31.0 percentage of participants |
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort | Percentage of Participants Receiving Phosphate Binding Agents | 60.9 percentage of participants |
| Q1 2011 | Percentage of Participants Receiving Phosphate Binding Agents | 66.0 percentage of participants |
| Q2 2011 | Percentage of Participants Receiving Phosphate Binding Agents | 70.4 percentage of participants |
| Q3 2011 | Percentage of Participants Receiving Phosphate Binding Agents | 74.2 percentage of participants |
| Q4 2011 | Percentage of Participants Receiving Phosphate Binding Agents | 73.3 percentage of participants |
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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort | Percentage of Participants Treated by Each Dialysis Modality | Peritoneal | 2.0 percentage of participants |
| Cohort | Percentage of Participants Treated by Each Dialysis Modality | Missing | 3.0 percentage of participants |
| Cohort | Percentage of Participants Treated by Each Dialysis Modality | Home hemodialysis | 0.5 percentage of participants |
| Cohort | Percentage of Participants Treated by Each Dialysis Modality | Hemodialysis (in center) | 94.4 percentage of participants |
| Q1 2011 | Percentage of Participants Treated by Each Dialysis Modality | Missing | 4.2 percentage of participants |
| Q1 2011 | Percentage of Participants Treated by Each Dialysis Modality | Hemodialysis (in center) | 93.0 percentage of participants |
| Q1 2011 | Percentage of Participants Treated by Each Dialysis Modality | Peritoneal | 2.2 percentage of participants |
| Q1 2011 | Percentage of Participants Treated by Each Dialysis Modality | Home hemodialysis | 0.7 percentage of participants |
| Q2 2011 | Percentage of Participants Treated by Each Dialysis Modality | Home hemodialysis | 0.6 percentage of participants |
| Q2 2011 | Percentage of Participants Treated by Each Dialysis Modality | Peritoneal | 3.6 percentage of participants |
| Q2 2011 | Percentage of Participants Treated by Each Dialysis Modality | Missing | 2.8 percentage of participants |
| Q2 2011 | Percentage of Participants Treated by Each Dialysis Modality | Hemodialysis (in center) | 93.0 percentage of participants |
| Q3 2011 | Percentage of Participants Treated by Each Dialysis Modality | Home hemodialysis | 0.7 percentage of participants |
| Q3 2011 | Percentage of Participants Treated by Each Dialysis Modality | Hemodialysis (in center) | 92.6 percentage of participants |
| Q3 2011 | Percentage of Participants Treated by Each Dialysis Modality | Peritoneal | 2.8 percentage of participants |
| Q3 2011 | Percentage of Participants Treated by Each Dialysis Modality | Missing | 3.9 percentage of participants |
| Q4 2011 | Percentage of Participants Treated by Each Dialysis Modality | Missing | 3.5 percentage of participants |
| Q4 2011 | Percentage of Participants Treated by Each Dialysis Modality | Peritoneal | 2.9 percentage of participants |
| Q4 2011 | Percentage of Participants Treated by Each Dialysis Modality | Hemodialysis (in center) | 93.0 percentage of participants |
| Q4 2011 | Percentage of Participants Treated by Each Dialysis Modality | Home hemodialysis | 0.6 percentage of participants |