End-Stage Renal DiseaseNCT00572533

Intelligent Control Approach to Anemia Management

A study testing ESA Dose Adjustment per standard Anemia Management Protocol and ESA Dose Adjustment per "Smart Anemia Manager" Algorithm in people with End-Stage Renal Disease, run by University of Louisville at 1 site in United States.

Completed

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

Official record

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Trial summary

First clinical evaluation of "Smart Anemia Manager" algorithm. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: End-Stage Renal Disease
What is being tested?: ESA Dose Adjustment per standard Anemia Management Protocol and ESA Dose Adjustment per "Smart Anemia Manager" Algorithm
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 62 participants
Where: 1 siteUnited States
Study dates: Apr 2011to Aug 2012
Phase: Interventional
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

ages 18 to 80,
receiving dialysis treatment,
receiving or expected to receive ESA treatment,
adequacy of dialysis Kt/V >= 1.2,
adequate iron stores (Ferritin > 200 ng/mL, TSat > 20%).

Who cannot join

life expectancy less than 12 months,
frequent uncontrolled blood loss,
frequent dialyzer clotting,
frequent access related problems,
active infections,
severe cardiac disability,

Show all 9Show fewer

coronary bypass within three months prior to the study
documented resistance to ESA
bone marrow suppression due to HIV, leukemia, or pharmacologic agents.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Louisville Kidney Disease Program
Louisville, Kentucky, 40202

Other trials in United States

About this study

Official title: Intelligent Control Approach to Anemia Management (AIM 4)

First clinical evaluation of "Smart Anemia Manager" algorithm.

Read the detailed description

The purpose of this single-center study is to test whether "Smart Anemia Manager" algorithm improves Hemoglobin stability compared to standard Anemia Management Protocol. Study site: Kidney Disease Program dialysis facility, University of Louisville, Louisville, KY.

Conditions: End-Stage Renal Disease
Being tested: ESA Dose Adjustment per standard Anemia Management Protocol, ESA Dose Adjustment per "Smart Anemia Manager" Algorithm
Keywords: End-Stage Renal Disease, Chronic Hemodialysis
Medical subject headings: Kidney Failure, Chronic

What participants receive

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

ESA Dose Adjustment per standard Anemia Management ProtocolOther
Also called AMP
Amount of ESA dose adjustment in Units per week guided by standard Anemia Management Protocol in use at the facility
ESA Dose Adjustment per "Smart Anemia Manager" AlgorithmOther
Also called SAM
Amount of ESA dose adjustment in Units per week individualized to subject's dose-response profile guided by "Smart Anemia Manager" algorithm

Study groups in NCT00572533
Study group	Role	What they receive
Control	Active comparator	ESA Dose Adjustment per standard Anemia Management Protocol Receives: Other: ESA Dose Adjustment per standard Anemia Management Protocol
Treatment	Experimental	ESA Dose Adjustment per "Smart Anemia Manager" Algorithm Receives: Other: ESA Dose Adjustment per "Smart Anemia Manager" Algorithm

What is being measured

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

Percent Hb 10-12 g/dL
Percentage of Hemoglobin concentrations measured (once per month) between 10 and 12 g/dL.
Measured: 12 months

Secondary outcomes (4)

Percent Hb < 10 g/dL
Percentage of Hemoglobin concentrations measured (once per month) less than 10 g/dL.
Measured: 12 months
Percent Hb > 12 g/dL
Percentage of Hemoglobin concentrations measured (once per month) greater than 12 g/dL.
Measured: 12 months
Mean Hb
Mean Hemoglobin concentration over follow-up period
Measured: 12 months
ESA Dose
Mean ESA dose per patient-week. ESA used: Epoetin Alfa (IV)
Measured: 12 months

Timeline

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

Apr 2011Aug 2012

First posted13 Dec 2007 (estimated)
Study startApr 2011
Primary completionApr 2012
Study completionAug 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 End-Stage Renal DiseaseStudies of the same condition, open and under way.
More trials run by University of LouisvilleThe 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: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Care provider
Enrolment: 62 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00572533
Sponsor's protocol ID: K25DK072085
Other IDs: K25DK072085, 1K25DK072085-01A2
Status last verified: Nov 2017
First submitted: 11 Dec 2007
Last updated: 13 Dec 2017
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

RecruitingPhase 1
A Study to Test the Safety of the Study Drug Fosmanogepix and How the Body Handles It in Adults With Severe Kidney Failure on Dialysis
End Stage Renal Disease on Dialysis, Adult
RecruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
Recruiting
Post Market Study for VasQ, an External Support Implant for Arteriovenous Fistula
End Stage Renal Disease
Not yet recruiting
Comparative Feasibility and Effectiveness of Medically Tailored Meals Approaches for Pediatric End-Stage Kidney Disease
End Stage Kidney Disease (ESKD)
Active, not recruiting
Medtronic Hugo™ Robotic Assisted Surgery (RAS) System in Urologic Surgery (Expand URO)
Bladder Cancer, Prostate Cancer

All End-Stage Renal Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Intelligent Control Approach to Anemia Management (AIM 4)
ClinicalTrials.gov ID: NCT00572533
Acronym / sponsor ID: K25DK072085
Conditions: End-Stage Renal Disease
Keywords: End-Stage Renal Disease, Chronic Hemodialysis
Study type: Interventional
Recruitment status: Completed
Enrolment: 62 participants (actual)
Lead sponsor: University of LouisvilleUniversity, hospital or other
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study start: Apr 2011
Primary completion: Apr 2012 (actual)
Study completion: Aug 2012 (actual)
First posted: 13 Dec 2007 (estimated)
Results: Posted 20 Dec 2012

Clinical summary

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

First clinical evaluation of "Smart Anemia Manager" algorithm.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, care provider)
Number of arms: 2

Arm	Type	Receives
Control	Active comparator	Other: ESA Dose Adjustment per standard Anemia Management ProtocolESA Dose Adjustment per standard Anemia Management Protocol
Treatment	Experimental	Other: ESA Dose Adjustment per "Smart Anemia Manager" AlgorithmESA Dose Adjustment per "Smart Anemia Manager" Algorithm

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

ages 18 to 80,
receiving dialysis treatment,
receiving or expected to receive ESA treatment,
adequacy of dialysis Kt/V >= 1.2,
adequate iron stores (Ferritin > 200 ng/mL, TSat > 20%).

Key exclusion criteria (9 listed)

life expectancy less than 12 months,
frequent uncontrolled blood loss,
frequent dialyzer clotting,
frequent access related problems,
active infections,

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

Interventions

Intervention	Type	Arms
ESA Dose Adjustment per standard Anemia Management ProtocolAlso: AMPAmount of ESA dose adjustment in Units per week guided by standard Anemia Management Protocol in use at the facility	Other	Control
ESA Dose Adjustment per "Smart Anemia Manager" AlgorithmAlso: SAMAmount of ESA dose adjustment in Units per week individualized to subject's dose-response profile guided by "Smart Anemia Manager" algorithm	Other	Treatment

Primary outcome

Percent Hb 10-12 g/dL
Time frame: 12 months
Percentage of Hemoglobin concentrations measured (once per month) between 10 and 12 g/dL.

4 secondary outcomes

Percent Hb < 10 g/dL
Time frame: 12 months
Percent Hb > 12 g/dL
Time frame: 12 months
Mean Hb
Time frame: 12 months
ESA Dose
Time frame: 12 months

Results and safety

Results posted to the registry on 20 Dec 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Control	31	24
Treatment	31	28

Primary outcome: Percent Hb 10-12 g/dL

Time frame: 12 months. Number. Unit: Percent

Measure	Control n = 31	Treatment n = 31
Value	61.9	72.5

Population analysed: Intent-To-Treat Analysis, Missing Data Excluded

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: 04/01/2011 - 03/31/2012. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Control	19 of 31 (61.3%)	17 of 31 (54.8%)	Not reported
Treatment	18 of 31 (58.1%)	16 of 31 (51.6%)	Not reported

Limitations and caveats (from the sponsor): 1. Single-center design 2. Small sample size 3. Homogenous population 4. Only maintenance dosing phase tested

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for End-Stage Renal Disease

RecruitingPhase 1
A Study to Test the Safety of the Study Drug Fosmanogepix and How the Body Handles It in Adults With Severe Kidney Failure on Dialysis
End Stage Renal Disease on Dialysis, Adult
RecruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
Recruiting
Post Market Study for VasQ, an External Support Implant for Arteriovenous Fistula
End Stage Renal Disease
Not yet recruiting
Comparative Feasibility and Effectiveness of Medically Tailored Meals Approaches for Pediatric End-Stage Kidney Disease
End Stage Kidney Disease (ESKD)
Active, not recruiting
Medtronic Hugo™ Robotic Assisted Surgery (RAS) System in Urologic Surgery (Expand URO)
Bladder Cancer, Prostate Cancer

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.

Adam E Gaweda, Ph.D. principal investigator

University of Louisville

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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 20 Dec 2012). 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?

Percent Hb 10-12 g/dL (time frame: 12 months). 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 NCT00572533.

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 13 Dec 2017.