Chronic Kidney DiseaseSTEPPS™NCT01717989

Study to Evaluate the Prospective Payment System

An observational study of Chronic Kidney Disease, run by Amgen at 41 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Any age
Conditions the study is for: Chronic Kidney Disease
How many people: 2,248 participants
Where: 41 sitesin 2 countries
Study dates: Jun 2010to Sep 2012
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: 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.

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.

Trial locations and contacts

41 sites in 2 countries.

Country

City, postcode or hospital

41 sites in 2 countries

United States40 sites

Research Site
Arlington, Texas, 76015
Research Site
Azusa, California, 91702
Research Site
Bakersfield, California, 93309
Research Site
Blairsville, Georgia, 30512
Research Site
Brooklyn, New York, 11235
Research Site
Columbia, Mississippi, 39429
Research Site
Covina, California, 91723
Research Site
East Point, Georgia, 30344
Research Site
Fairfax, Virginia, 22030
Research Site
Glendale, California, 91205
Research Site
Gulf Shores, Alabama, 36542
Research Site
Hacienda Heights, California, 91745
Research Site
Honolulu, Hawaii, 96816
Research Site
Honolulu, Hawaii, 96817
Research Site
Houston, Texas, 77004
Research Site
Houston, Texas, 77021
Research Site
Houston, Texas, 77074
Research Site
Inglewood, California, 90301
Research Site
King, North Carolina, 27021
Research Site
Lancaster, California, 93534
Research Site
Lincoln, Nebraska, 68510
Research Site
Lincoln, Nebraska, 68512
Research Site
Lincoln, Nebraska, 68521
Research Site
Livingston, New Jersey, 07039
Research Site
Los Angeles, California, 90095
Research Site
Maspeth, New York, 11378
Research Site
New York, New York, 10016
Research Site
Northridge, California, 91324
Research Site
Pachuta, Mississippi, 39347
Research Site
Pembroke Pines, Florida, 33028
Research Site
Quincy, Illinois, 62301
Research Site
San Dimas, California, 91773
Research Site
Siloam Springs, Arkansas, 72761
Research Site
South Charleston, West Virginia, 25015
Research Site
Springdale, Arkansas, 72764
Research Site
The Bronx, New York, 10461
Research Site
West Covina, California, 91790
Research Site
Whittier, California, 90606
Research Site
Winston-Salem, North Carolina, 27103
Research Site
Yadkinville, North Carolina, 27055

Other trials in United States

Puerto Rico1 site

Research Site
San Juan, 00936

Other trials in Puerto Rico

About this study

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

Conditions: Chronic Kidney Disease
Keywords: Dialysis, Prospective Payment System, Center for Medicare and Medicaide Services, End Stage Renal Disease, Concomitant Medications Dosage /Treatment patterns
Medical subject headings: Renal Insufficiency, Chronic, Kidney Failure, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01717989
Study group	Role	What they receive
Cohort		Patients with end-stage renal disease (ESRD) treated at small dialysis organizations (SDOs).

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: Data were collected monthly from June 2010 until September 2012

Secondary outcomes (12)

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.
Measured: Fourth quarter (Q4) 2010, Q1 2011, Q2 2011, Q3 2011, and Q4 2011.
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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: Fourth quarter (Q4) 2010, Q1 2011, Q2 2011, Q3 2011, and Q4 2011.
Mean Hemoglobin Concentration by Quarter
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: December 2010, March 2011, June 2011, September 2011, December 2011
Number of Participants With Transfusions, Hospitalizations, Mortality, and Transfers Out
Measured: June to December 2010, Q1 2011, Q2 2011, Q3 2011, and Q4 2011.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2010Sep 2012

First posted31 Oct 2012 (estimated)
Study startJun 2010
Primary completionSep 2012
Study completionSep 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
More trials run by AmgenThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 2,248 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01717989
Sponsor's protocol ID: 20080234
Acronym: STEPPS™
Status last verified: Nov 2013
First submitted: 12 Sep 2012
Last updated: 14 Jan 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Chronic Kidney Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Study to Evaluate the Prospective Payment System Impact on Small Dialysis Organizations
ClinicalTrials.gov ID: NCT01717989
Acronym / sponsor ID: STEPPS™ / 20080234
Conditions: Chronic Kidney Disease
Keywords: Dialysis, Prospective Payment System, Center for Medicare and Medicaide Services, End Stage Renal Disease, Concomitant Medications Dosage /Treatment patterns
Study type: Observational
Recruitment status: Completed
Enrolment: 2,248 participants (actual)
Lead sponsor: AmgenIndustry (pharma, biotech, devices)
Study start: Jun 2010
Primary completion: Sep 2012 (actual)
Study completion: Sep 2012 (actual)
First posted: 31 Oct 2012 (estimated)
Results: Posted 14 Jan 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Cohort	–	–Patients with end-stage renal disease (ESRD) treated at small dialysis organizations (SDOs).

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: 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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Percentage of Participants Per Facility With Hemoglobin < 10 g/dL
Time frame: 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
Time frame: 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%
Time frame: 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.

12 secondary outcomes

Percentage of Participants Treated by Each Dialysis Modality
Time frame: Fourth quarter (Q4) 2010, Q1 2011, Q2 2011, Q3 2011, and Q4 2011.
Percentage of Participants in Each Vascular Access Type Category
Time frame: Fourth quarter (Q4) 2010, Q1 2011, Q2 2011, Q3 2011, and Q4 2011.
Percentage of Participants Per Facility Receiving Erythropoietin Stimulation Agents (ESA)
Time frame: Fourth quarter (Q4) 2010, Q1 2011, Q2 2011, Q3 2011, and Q4 2011.
Percentage of Participants Receiving Cinacalcet
Time frame: Fourth quarter (Q4) 2010, Q1 2011, Q2 2011, Q3 2011, and Q4 2011.
Percentage of Participants Receiving Phosphate Binding Agents
Time frame: Fourth quarter (Q4) 2010, Q1 2011, Q2 2011, Q3 2011, and Q4 2011.
Percentage of Participants Receiving a Vitamin D Sterol
Time frame: Fourth quarter (Q4) 2010, Q1 2011, Q2 2011, Q3 2011, and Q4 2011.
Mean Hemoglobin Concentration by Quarter
Time frame: 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
Time frame: 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
Time frame: December 2010, March 2011, June 2011, September 2011, December 2011
Cumulative Monthly Dose of Epoetin Alfa Administered
Time frame: December 2010, March 2011, June 2011, September 2011, December 2011
Number of Participants Taking Epoetin Alfa by Month
Time frame: December 2010, March 2011, June 2011, September 2011, December 2011
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.

Results and safety

Results posted to the registry on 14 Jan 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cohort	2,248	1,182

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

Time frame: Data were collected monthly from June 2010 until September 2012. Mean (95% Confidence Interval). Unit: percentage of participants per facility

Measure	Cohort n = 2248
June 2010 (n=39)	11.5 (9.4 to 13.6)
July 2010 (n=45)	11.0 (8.3 to 13.8)
August 2010 (n=50)	13.1 (10.9 to 15.0)
September 2010 (n=51)	12.0 (10.0 to 13.9)
October 2010 (n=51)	12.7 (11.1 to 14.2)
November 2010 (n=51)	13.2 (11.3 to 15.0)
December 2010 (n=51)	14.3 (11.9 to 16.4)
January 2011 (n=50)	13.5 (11.6 to 15.3)

Population analysed: 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).

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

Time frame: Data were collected monthly from June 2010 until September 2012. Mean (95% Confidence Interval). Unit: percentage of participants per facility

Measure	Cohort n = 2248
June 2010 (n=39)	30.2 (25.4 to 35.5)
July 2010 (n=45)	28.3 (25.1 to 31.6)
August 2010 (n=50)	28.2 (25.2 to 31.5)
September 2010 (n=51)	30.6 (27.7 to 34.0)
October 2010 (n=51)	28.7 (26.4 to 31.3)
November 2010 (n=51)	27.8 (24.9 to 30.8)
December 2010 (n=51)	24.5 (22.1 to 27.2)
January 2011 (n=50)	25.6 (22.7 to 29.0)

Population analysed: 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).

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

Time frame: Data were collected monthly from June 2010 until September 2012. Mean (95% Confidence Interval). Unit: percentage of participants per facility

Measure	Cohort n = 2248
June 2010 (n=37)	84.8 (81.4 to 88.3)
July 2010 (n=44)	85.0 (81.5 to 88.5)
August 2010 (n=49)	85.0 (82.5 to 87.5)
September 2010 (n=50)	86.9 (84.3 to 89.5)
October 2010 (n=50)	87.9 (85.2 to 90.3)
November 2010 (n=50)	87.8 (85.2 to 90.3)
December 2010 (n=50)	86.9 (84.3 to 89.3)
January 2011 (n=49)	85.5 (82.1 to 88.7)

Population analysed: 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).

12 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 28 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cohort	1 of 2,248 (0%)	0 of 0	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
AmgenTrials clinical trials websiteLink provided by the sponsor.

Related trials for Chronic Kidney Disease

Recruiting
Post Market Study for VasQ, an External Support Implant for Arteriovenous Fistula
End Stage Renal Disease
RecruitingObservational study
A Natural History Study of Metabolic Sizing in Health and Disease
Metabolic Disorders, Cancer
Not yet recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

MD study director

Amgen

41 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Kidney Disease, run by Amgen at 41 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 41 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Jan 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Per Facility With Hemoglobin < 10 g/dL (time frame: Data were collected monthly from June 2010 until September 2012). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01717989.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2014.