End Stage Renal DiseaseNCT00788905
Comparison of Conventional Dialysis and the Allient System
A study testing Allient System in people with End Stage Renal Disease and Chronic Kidney Failure, run by Renal Research Institute at 3 sites in United States.
Trial summary
The purpose of the study to determine whether the level of inflammation may be decreased, the lifespan of red blood cells increased and the clearance of waste products in the blood improved through the use of the Allient System as compared to conventional hemodialysis. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- End Stage Renal Disease, Chronic Kidney Failure
- What is being tested?
- Allient System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 3 sitesUnited States
- Study dates
- Nov 2008to Jan 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Maintenance in-center hemodialysis
- Age greater than or equal to 18 years
- Has been on hemodialysis for at least 4 months
- Uses a standard single-pass dialysis machine with a high-flux dialyzer
Who cannot join
- Hospitalization during the 8 weeks preceding enrollment
- Infection requiring antibiotic treatment during the 8 weeks preceding enrollment
- Central venous cather as dialysis access
- Uncontrollable blood coagulation anomalies
- Smokers
- Dialysis regimen other than 3 times weekly
- In ability to understand the English language and give informed consent for participation in the study
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Irving Place Dialysis Center
New York, New York, 10003
Upper Manhattan Dialysis Center
New York, New York, 10025
Yorkville Dialysis Center
New York, New York, 10128
About this study
Official title: Uremic Toxin Removal, Blood Cell Kinetics, and Inflammatory Response in Patients Treated With the Allient System
The purpose of the study to determine whether the level of inflammation may be decreased, the lifespan of red blood cells increased and the clearance of waste products in the blood improved through the use of the Allient System as compared to conventional hemodialysis.
- Conditions
- End Stage Renal Disease, Chronic Kidney Failure
- Being tested
- Allient System
- Keywords
- 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.
Allient SystemDevice
The Allient System uses a different type of blood pump and a lower volume of dialysate.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Subject will continue conventional hemodialysis therapy for one week ("no intervention" phase) and then swtich to the Allient system for two weeks ("active comparator" phase). Receives: Device: Allient System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clearance of specific waste products from blood determined through subject blood and dialysate samples
Measured: 3 weeks
Secondary outcomes (2)
Inflammation as determined by levels of specific inflammatory markers
Measured: 3 weeks
Red blood cell lifespan determined through a measurement of CO in the subject's breath
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2008 (estimated)
- Study startNov 2008
- Primary completionFeb 2011
- Study completionJan 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Renal Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Renal Solutions, Inc.
- Responsible party
- Sponsor
- Investigators
- Nathan W. Levin, MD, Principal investigator, Renal Research InstitutePeter Kotanko, MD, Study director, Renal Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00788905
- Sponsor's protocol ID
- 065-08
- Status last verified
- Mar 2013
- First submitted
- 23 Sep 2008
- Last updated
- 29 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Rosales L, Thijssen S, Kruse A, Sipahioglu MH, Hirachan P, Raimann JG, Kuntsevich V, Carter M, Levin NW, Kotanko P. Inflammatory Response to Sorbent Hemodialysis. ASAIO J. 2015 Jul-Aug;61(4):463-7. doi: 10.1097/MAT.0000000000000212.
PubMed 25710773
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Uremic Toxin Removal, Blood Cell Kinetics, and Inflammatory Response in Patients Treated With the Allient System
- ClinicalTrials.gov ID
- NCT00788905
- Acronym / sponsor ID
- 065-08
- Conditions
- End Stage Renal Disease, Chronic Kidney Failure
- Keywords
- Hemodialysis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Renal Research InstituteUniversity, hospital or other
- Collaborators
- Renal Solutions, Inc.
- Study start
- Nov 2008
- Primary completion
- Feb 2011 (actual)
- Study completion
- Jan 2014 (estimated)
- First posted
- 11 Nov 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study to determine whether the level of inflammation may be decreased, the lifespan of red blood cells increased and the clearance of waste products in the blood improved through the use of the Allient System as compared to conventional hemodialysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Device: Allient SystemSubject will continue conventional hemodialysis therapy for one week ("no intervention" phase) and then swtich to the Allient system for two weeks ("active comparator" phase). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Maintenance in-center hemodialysis
- Age greater than or equal to 18 years
- Has been on hemodialysis for at least 4 months
- Uses a standard single-pass dialysis machine with a high-flux dialyzer
Key exclusion criteria (7 listed)
- Hospitalization during the 8 weeks preceding enrollment
- Infection requiring antibiotic treatment during the 8 weeks preceding enrollment
- Central venous cather as dialysis access
- Uncontrollable blood coagulation anomalies
- Smokers
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 |
|---|---|---|
| Allient SystemThe Allient System uses a different type of blood pump and a lower volume of dialysate. | Device | A |
Primary outcome
Clearance of specific waste products from blood determined through subject blood and dialysate samples
Time frame: 3 weeks
2 secondary outcomes
Inflammation as determined by levels of specific inflammatory markers
Time frame: 3 weeks
Red blood cell lifespan determined through a measurement of CO in the subject's breath
Time frame: 3 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2013.
- Derived from this study: PubMed 25710773Rosales L, Thijssen S, Kruse A, Sipahioglu MH, Hirachan P, Raimann JG, Kuntsevich V, Carter M, Levin NW, Kotanko P. Inflammatory Response to Sorbent Hemodialysis. ASAIO J. 2015 Jul-Aug;61(4):463-7. doi: 10.1097/MAT.0000000000000212.
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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.
Nathan W. Levin, MD principal investigator
Renal Research Institute
Peter Kotanko, MD study director
Renal Research Institute
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Allient System in people with End Stage Renal Disease and Chronic Kidney Failure, run by Renal Research Institute at 3 sites in United States.
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 4 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 29 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Results are not available in the source record.
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?
Clearance of specific waste products from blood determined through subject blood and dialysate samples (time frame: 3 weeks). 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 NCT00788905, which also lists 1 linked publication.
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 29 Mar 2013.