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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort | Patients with end-stage renal disease (ESRD) treated at small dialysis organizations (SDOs). |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Data were collected monthly from June 2010 until September 2012 |
| 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. | Data were collected monthly from June 2010 until September 2012 |
| 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. | Data were collected monthly from June 2010 until September 2012 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Fourth quarter (Q4) 2010, Q1 2011, Q2 2011, Q3 2011, and Q4 2011. |
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Patient Inclusion Criteria:
Patient Exclusion Criteria:
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The study population will consist of approximately 50 SDOs selected to participate in the registry. All efforts will be made to select a diversified group of facilities by evaluating geography, facility size (i.e., number of patients treated) and setting (i.e., rural and urban settings) and potentially, dialysis modalities offered as well as payor mix.
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Gulf Shores | Alabama | 36542 | United States | ||
| Research Site |
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| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort | Patients with end-stage renal disease (ESRD) treated at small dialysis organizations (SDOs). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| 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. | Fourth quarter (Q4) 2010, Q1 2011, Q2 2011, Q3 2011, and Q4 2011. |
| 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. | Fourth quarter (Q4) 2010, Q1 2011, Q2 2011, Q3 2011, and Q4 2011. |
| Percentage of Participants Receiving Cinacalcet | The percentage of participants receiving cinacalcet (Sensipar) over time | Fourth quarter (Q4) 2010, Q1 2011, Q2 2011, Q3 2011, and Q4 2011. |
| Percentage of Participants Receiving Phosphate Binding Agents | The percentage of participants receiving phosphate binding agents over time | Fourth quarter (Q4) 2010, Q1 2011, Q2 2011, Q3 2011, and Q4 2011. |
| 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. | Fourth quarter (Q4) 2010, Q1 2011, Q2 2011, Q3 2011, and Q4 2011. |
| Mean Hemoglobin Concentration by Quarter | Fourth quarter (Q4) 2010, Q1 2011, Q2 2011, Q3 2011, and Q4 2011. |
| 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. | December 2010, March 2011, June 2011, September 2011, December 2011 |
| 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. | December 2010, March 2011, June 2011, September 2011, December 2011 |
| Cumulative Monthly Dose of Epoetin Alfa Administered | The cumulative monthly intravenous epoetin alfa dose in participants on hemodialysis. | December 2010, March 2011, June 2011, September 2011, December 2011 |
| Number of Participants Taking Epoetin Alfa by Month | The number of participants who took epoetin alfa only, by month, in participants on hemodialysis. | December 2010, March 2011, June 2011, September 2011, December 2011 |
| Number of Participants With Transfusions, Hospitalizations, Mortality, and Transfers Out | June to December 2010, Q1 2011, Q2 2011, Q3 2011, and Q4 2011. |
| Siloam Springs |
| Arkansas |
| 72761 |
| United States |
| Research Site | Springdale | Arkansas | 72764 | United States |
| Research Site | Azusa | California | 91702 | United States |
| Research Site | Bakersfield | California | 93309 | United States |
| Research Site | Covina | California | 91723 | United States |
| Research Site | Glendale | California | 91205 | United States |
| Research Site | Hacienda Heights | California | 91745 | United States |
| Research Site | Inglewood | California | 90301 | United States |
| Research Site | Lancaster | California | 93534 | United States |
| Research Site | Los Angeles | California | 90095 | United States |
| Research Site | Northridge | California | 91324 | United States |
| Research Site | San Dimas | California | 91773 | United States |
| Research Site | West Covina | California | 91790 | United States |
| Research Site | Whittier | California | 90606 | United States |
| Research Site | Pembroke Pines | Florida | 33028 | United States |
| Research Site | Blairsville | Georgia | 30512 | United States |
| Research Site | East Point | Georgia | 30344 | United States |
| Research Site | Honolulu | Hawaii | 96816 | United States |
| Research Site | Honolulu | Hawaii | 96817 | United States |
| Research Site | Quincy | Illinois | 62301 | United States |
| Research Site | Columbia | Mississippi | 39429 | United States |
| Research Site | Pachuta | Mississippi | 39347 | United States |
| Research Site | Lincoln | Nebraska | 68510 | United States |
| Research Site | Lincoln | Nebraska | 68512 | United States |
| Research Site | Lincoln | Nebraska | 68521 | United States |
| Research Site | Livingston | New Jersey | 07039 | United States |
| Research Site | Brooklyn | New York | 11235 | United States |
| Research Site | Maspeth | New York | 11378 | United States |
| Research Site | New York | New York | 10016 | United States |
| Research Site | The Bronx | New York | 10461 | United States |
| Research Site | King | North Carolina | 27021 | United States |
| Research Site | Winston-Salem | North Carolina | 27103 | United States |
| Research Site | Yadkinville | North Carolina | 27055 | United States |
| Research Site | Arlington | Texas | 76015 | United States |
| Research Site | Houston | Texas | 77004 | United States |
| Research Site | Houston | Texas | 77021 | United States |
| Research Site | Houston | Texas | 77074 | United States |
| Research Site | Fairfax | Virginia | 22030 | United States |
| Research Site | South Charleston | West Virginia | 25015 | United States |
| Research Site | San Juan | 00936 | Puerto Rico |
| COMPLETED |
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| NOT COMPLETED |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort | Patients with end-stage renal disease (ESRD) treated at small dialysis organizations (SDOs). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Dialysis modality at enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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). | Posted | Mean | 95% Confidence Interval | percentage of participants per facility | Data were collected monthly from June 2010 until September 2012 | SDO facilities | 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. | Primary Analysis Set participants on study at each time point | Posted | Number | percentage of participants | Fourth quarter (Q4) 2010, Q1 2011, Q2 2011, Q3 2011, and Q4 2011. |
| ||||||||||||||||||||||||||||||||||||||||
| 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. | 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). | Posted | Mean | 95% Confidence Interval | percentage of participants per facility | Data were collected monthly from June 2010 until September 2012 | SDO facilities | Participants |
|
| ||||||||||||||||||||||||||||||||||||
| 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. | 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). | Posted | Mean | 95% Confidence Interval | percentage of participants per facility | Data were collected monthly from June 2010 until September 2012 | SDO facilities | Participants |
|
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| 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. | Primary Analysis Set participants on study and on hemodialysis at each time point | Posted | Number | percentage of participants | Fourth quarter (Q4) 2010, Q1 2011, Q2 2011, Q3 2011, and Q4 2011. |
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| 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. | Primary Analysis Set facilities / participants on study at each time point. | Posted | Mean | 95% Confidence Interval | percentage of participants per facility | Fourth quarter (Q4) 2010, Q1 2011, Q2 2011, Q3 2011, and Q4 2011. | Facilities | Participants |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Receiving Cinacalcet | The percentage of participants receiving cinacalcet (Sensipar) over time | Primary Analysis Set participants on study at each time point | Posted | Number | percentage of participants | Fourth quarter (Q4) 2010, Q1 2011, Q2 2011, Q3 2011, and Q4 2011. |
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Receiving Phosphate Binding Agents | The percentage of participants receiving phosphate binding agents over time | Primary Analysis Set participants on study at each time point | Posted | Number | percentage of participants | Fourth quarter (Q4) 2010, Q1 2011, Q2 2011, Q3 2011, and Q4 2011. |
| ||||||||||||||||||||||||||||||||||||||||
| 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. | Primary Analysis Set participants on study at each time point | Posted | Number | percentage of participants | Fourth quarter (Q4) 2010, Q1 2011, Q2 2011, Q3 2011, and Q4 2011. |
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Hemoglobin Concentration by Quarter | Primary Analysis Set participants on study at each time point and with available data. | Posted | Mean | Standard Deviation | g/dL | Fourth quarter (Q4) 2010, Q1 2011, Q2 2011, Q3 2011, and Q4 2011. |
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| 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. | 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. | Posted | Number | percentage of facilities | December 2010, March 2011, June 2011, September 2011, December 2011 | Facilities | Participants |
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| 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. | Facilities / participants with at least one non-missing transferrin saturation or ferritin record at each time point. | Posted | Mean | 95% Confidence Interval | percentage of participants per facility | December 2010, March 2011, June 2011, September 2011, December 2011 | Facilities | Participants |
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| Secondary | Cumulative Monthly Dose of Epoetin Alfa Administered | The cumulative monthly intravenous epoetin alfa dose in participants on hemodialysis. | Primary Analysis Set participants on study and on hemodialysis and receiving epoetin alfa at each time point and with available data. | Posted | Median | Inter-Quartile Range | units | December 2010, March 2011, June 2011, September 2011, December 2011 |
|
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| Secondary | Number of Participants Taking Epoetin Alfa by Month | The number of participants who took epoetin alfa only, by month, in participants on hemodialysis. | Primary Analysis Set participants on study and on hemodialysis at each time point. | Posted | Number | participants | December 2010, March 2011, June 2011, September 2011, December 2011 |
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| Secondary | Number of Participants With Transfusions, Hospitalizations, Mortality, and Transfers Out | Primary Analysis Set participants on study at each time point | Posted | Number | participants | June to December 2010, Q1 2011, Q2 2011, Q3 2011, and Q4 2011. |
|
|
Up to 28 months
As this was a non-interventional observational study, only serious adverse drug reactions (SADRs) relating to Amgen products were reported. An adverse drug reaction (ADR) was defined for this study as any undesirable experience or worsening of a pre-existing medical condition associated with the use of a medicine in a clinical study participant.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort | Patients with end-stage renal disease (ESRD) treated at small dialysis organizations (SDOs). | 1 | 2,248 | 0 | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cerebrovascular accident | Nervous system disorders | MedDRA version 15.1 | Systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA version 15.1 | Systematic Assessment |
|
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The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results aftercompletion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Amgen Inc. | 866-572-6436 |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Black or African American |
|
| White |
|
| Other |
|
| Unknown |
|
| Home hemodialysis |
|
| Missing |
|
| Title | Measurements |
|---|---|
|
| September 2010 (n=51) |
|
| October 2010 (n=51) |
|
| November 2010 (n=51) |
|
| December 2010 (n=51) |
|
| January 2011 (n=50) |
|
| February 2011 (n=50) |
|
| March 2011 (n=50) |
|
| April 2011 (n=50) |
|
| May 2011 (n=50) |
|
| June 2011 (n=50) |
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| July 2011 (n=50) |
|
| August 2011 (n=50) |
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| September 2011 (n=50) |
|
| October 2011 (n=50) |
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| November 2011 (n=50) |
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| December 2011 (n=48) |
|
| January 2012 (n=48) |
|
| February 2012 (n=48) |
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| March 2012 (n=48) |
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| April 2012 (n=48) |
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| May 2012 (n=48) |
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| June 2012 (n=45) |
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| July 2012 (n=45) |
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| August 2012 (n=45) |
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| September 2012 (n=45) |
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| SDO facilities |
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| SDO facilities |
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| Units | Counts |
|---|---|
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| Q4 2011 |
Fourth quarter, 2011 |
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| Participants |
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| Participants |
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| Participants |
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