Renal FailureSorb2NCT01437761
Sorbent Treatment Prescriptions Pilot Study
An observational study of Renal Failure, run by Renal Research Institute at 1 site in United States.
Trial summary
This study will compare how well blood of renal failure patients is cleaned with the new 2008 Sorbent System using two different dialysate speeds. Read more about this study
- Who is it for?
- Ages 18 to 88 years
- Conditions the study is for
- Renal Failure
- What is being tested?
- 2008 Sorbent System
- Type of treatment
- Medical device
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to Jan 2012
- Phase
- Observational
- 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 88 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: End-stage renal disease patients
Who may be able to join
- age </=18 years
- end-stage renal disease (ESRD) patient on chronic high-flux hemodialysis for </= 6 months at time of enrollment
- well-functioning fistula, graft or catheter as hemodialysis access, achieving blood flow rates of >/= 300 mL/min
- ability to understand the English language
Who cannot join
- Pre-dialysis serum blood urea nitrogen (BUN) concentration below 30 mg/dL in the last three months
- Severe Coronary Heart Disease or Heart Failure (New York Heart Association class IV)
- Active Infections
- Hepatitis B
- Any other active infection that has required antibiotic treatment in the preceding eight weeks
- Pre-study lab values of any of the following (in the most recent routine lab work)
Show all 9Show fewer
- Sodium - Na+ > 150 mmol/L, Na+ < 132 mmol/L
- Potassium - K+ > 6.5 mmol/L, K+ < 3.5 mmol/L
- Total Calcium - Ca > 12 mg/dL (3 mmol/L), total Ca < 7.2 mg/dL (1.8 mmol/L)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hemodialysis With the 2008 Sorbent System: A Pilot Evaluation of Different Treatment Prescriptions
This study will compare how well blood of renal failure patients is cleaned with the new 2008 Sorbent System using two different dialysate speeds.
Read the detailed description
The "2008 Sorbent System" is a new type of hemodialysis machine that requires only about 2 gallons of dialysate for a treatment because it can turn used dialysate into fresh dialysate again by filtering it through a special cleaning cartridge (called a "sorbent"). This new machine is approved by the U.S. Food and Drug Administration to clean the blood of patients whose kidneys have failed.
This study will compare the degree of blood cleansing achieved with the new 2008 Sorbent System using two different speeds at which the dialysate runs through the dialysis machine. This will tell us if the faster speed really does provide better cleaning (and how much) with this new machine.
How well the blood of a patient is cleaned by this procedure is determined by several factors. For example, longer treatment times generally provide better blood cleansing. Higher speeds at which the cleaning fluid runs through the artificial kidney do, too.
Since the 2008 Sorbent System is a new machine (and in some ways different from standard hemodialysis machines), other aspects may be different, too, between the 2008 Sorbent System and regular hemodialysis machines. Specifically, this study looks at how well this new machine corrects the patients' acid-base status (a common requirement in these patients), what effect the treatment has on inflammation in the patients' blood, how the levels of important substances in the blood are influenced (acetate, sulfate, nitrate, carbon dioxide), and if cleaning fluid in the 2008 Sorbent System contains any substances that are not found in the cleaning fluid used by regular hemodialysis machines.
- Conditions
- Renal Failure
- Being tested
- 2008 Sorbent System
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2008 Sorbent SystemDevice
2008 Sorbent System with dialysate flow rates (Qd) of 400 and 500 ml/min while maintaining a constant blood flow rate (Qb) and constant dialyzer (KoA).
| Study group | Role | What they receive |
|---|---|---|
| 2008 Sorbent system | Hemodialysis with the 2008 Sorbent system Receives: Device: 2008 Sorbent System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Adequacy
spKt/V, eKt/V, and Std Weekly Kt/V (Kt/V = dialysis adequacy)
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2011 (estimated)
- Study startAug 2011
- Primary completionNov 2011
- Study completionJan 2012
Why it stopped: Change of Institutional Affliation \& Funding Changes
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal FailureStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Renal Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Renal Solutions, Inc.
- Responsible party
- Sponsor
- Investigators
- Peter Kotanko, MD, Principal investigator, Renal Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01437761
- Sponsor's protocol ID
- 150-11
- Acronym
- Sorb2
- Status last verified
- Apr 2017
- First submitted
- 19 Sep 2011
- Last updated
- 12 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemodialysis With the 2008 Sorbent System: A Pilot Evaluation of Different Treatment Prescriptions
- ClinicalTrials.gov ID
- NCT01437761
- Acronym / sponsor ID
- Sorb2 / 150-11
- Conditions
- Renal Failure
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Change of Institutional Affliation \& Funding Changes
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Renal Research InstituteUniversity, hospital or other
- Collaborators
- Renal Solutions, Inc.
- Study start
- Aug 2011
- Primary completion
- Nov 2011 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 21 Sep 2011 (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.
This study will compare how well blood of renal failure patients is cleaned with the new 2008 Sorbent System using two different dialysate speeds.
Detailed description
The "2008 Sorbent System" is a new type of hemodialysis machine that requires only about 2 gallons of dialysate for a treatment because it can turn used dialysate into fresh dialysate again by filtering it through a special cleaning cartridge (called a "sorbent"). This new machine is approved by the U.S. Food and Drug Administration to clean the blood of patients whose kidneys have failed.
This study will compare the degree of blood cleansing achieved with the new 2008 Sorbent System using two different speeds at which the dialysate runs through the dialysis machine. This will tell us if the faster speed really does provide better cleaning (and how much) with this new machine.
How well the blood of a patient is cleaned by this procedure is determined by several factors. For example, longer treatment times generally provide better blood cleansing. Higher speeds at which the cleaning fluid runs through the artificial kidney do, too.
Since the 2008 Sorbent System is a new machine (and in some ways different from standard hemodialysis machines), other aspects may be different, too, between the 2008 Sorbent System and regular hemodialysis machines. Specifically, this study looks at how well this new machine corrects the patients' acid-base status (a common requirement in these patients), what effect the treatment has on inflammation in the patients' blood, how the levels of important substances in the blood are influenced (acetate, sulfate, nitrate, carbon dioxide), and if cleaning fluid in the 2008 Sorbent System contains any substances that are not found in the cleaning fluid used by regular hemodialysis machines.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 2008 Sorbent system | – | Device: 2008 Sorbent SystemHemodialysis with the 2008 Sorbent system |
Who may qualify
- Ages
- 18 to 88 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- End-stage renal disease patients
Key inclusion criteria (4 listed)
- age </=18 years
- end-stage renal disease (ESRD) patient on chronic high-flux hemodialysis for </= 6 months at time of enrollment
- well-functioning fistula, graft or catheter as hemodialysis access, achieving blood flow rates of >/= 300 mL/min
- ability to understand the English language
Key exclusion criteria (9 listed)
- Pre-dialysis serum blood urea nitrogen (BUN) concentration below 30 mg/dL in the last three months
- Severe Coronary Heart Disease or Heart Failure (New York Heart Association class IV)
- Active Infections
- Hepatitis B
- Any other active infection that has required antibiotic treatment in the preceding eight weeks
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 |
|---|---|---|
| 2008 Sorbent System2008 Sorbent System with dialysate flow rates (Qd) of 400 and 500 ml/min while maintaining a constant blood flow rate (Qb) and constant dialyzer (KoA). | Device | 2008 Sorbent system |
Primary outcome
Treatment Adequacy
Time frame: 4 weeks
spKt/V, eKt/V, and Std Weekly Kt/V (Kt/V = dialysis adequacy)
Results and safety
The study was stopped early (reason given: Change of Institutional Affliation \& Funding Changes). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2017.
- Individual participant dataSharing planned: No
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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.
Peter Kotanko, MD principal investigator
Renal Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Failure, run by Renal Research Institute at 1 site 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 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: stopped early, as of the sponsor's last update on 12 Apr 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?
The study was stopped early (reason given: Change of Institutional Affliation \& Funding Changes). 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?
Treatment Adequacy (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Apr 2017; AzTrials last refreshed its copy on 4 Nov 2026.