Kidney FailurePhase 2hemodialysisNCT00633308
Phosphorus and Calcium Removal During Long Hemodialysis Treatment Sessions
A Phase 2 study testing NxStage System One (NxStage Medical, Lawrence, MA) in people with Kidney Failure, run by Indiana University.
Trial summary
The purpose of this sudy is to determined the effect of dialysate volume and treatment time on phosphate and calcium removal in stage V chronickidney disease patients treated by hemodialysis using the System One (NxStage Medical, Lawrence, MA) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Failure
- What is being tested?
- NxStage System One (NxStage Medical, Lawrence, MA)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Mar 2008to Feb 2011
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stage V chronic kidney patients with minimal or no residual renal functin
Who cannot join
- Medically unstable
- Hematocrit less than 28%
- Hepatitis B positive, hepatitis C positive or HIV positive
- Pregnant women
- Minors below 18 years of age
- Active psychiatric disease
About this study
The purpose of this sudy is to determined the effect of dialysate volume and treatment time on phosphate and calcium removal in stage V chronickidney disease patients treated by hemodialysis using the System One (NxStage Medical, Lawrence, MA)
Read the detailed description
Ten patients will be recruited from those routinely treated in-center or at home using the Systerm One at the clinical centers. Each patient will be studiesd on 4 separate occastions. Treatments under the following conditions will each be performed on each study patient, at least one week apart:
- Treatment for 8 hrs uding 40L of dialysate
- Treatment for 8 hrs using 60L of dialysate
- Treatment for 5 hrs using 40L of dialysate
- Treatment for 5 hrs using 60L of dialysate
Blood samples will be collected and assayed for the concentrations of urea, phosphate, calcium, bicarbonate, beta-2-microglobulin and albumin using standard assays.
- Conditions
- Kidney Failure
- Being tested
- NxStage System One (NxStage Medical, Lawrence, MA)
- Keywords
- hemodialysis
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NxStage System One (NxStage Medical, Lawrence, MA)Device
Also called The System One (NxStage Medical, Lawrence, MA)
Each patient will be studied on 4 separate occasions. The study sessions are longer than routine daily hemodialysis therapy using the System One.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Long hemodialysis Receives: Device: NxStage System One (NxStage Medical, Lawrence, MA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
the effect of dialysate volume and treatment time on phosphage and calcium removal
Measured: 4 treatments
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2008 (estimated)
- Study startMar 2008
- Primary completionJan 2010 (estimated)
- Study completionFeb 2011 (estimated)
Why it stopped: No coordinator available to work on study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney FailureStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Investigators
- Michael Kraus, M.D., Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00633308
- Sponsor's protocol ID
- NxStage LongHD
- Acronym
- hemodialysis
- Status last verified
- Feb 2016
- First submitted
- 21 Feb 2008
- Last updated
- 1 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phosphorus and Calcium Removal During Long Hemodialysis Treatment Sessions
- ClinicalTrials.gov ID
- NCT00633308
- Acronym / sponsor ID
- hemodialysis / NxStage LongHD
- Conditions
- Kidney Failure
- Keywords
- hemodialysis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No coordinator available to work on study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Jan 2010 (estimated)
- Study completion
- Feb 2011 (estimated)
- First posted
- 12 Mar 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 this sudy is to determined the effect of dialysate volume and treatment time on phosphate and calcium removal in stage V chronickidney disease patients treated by hemodialysis using the System One (NxStage Medical, Lawrence, MA)
Detailed description
Ten patients will be recruited from those routinely treated in-center or at home using the Systerm One at the clinical centers. Each patient will be studiesd on 4 separate occastions. Treatments under the following conditions will each be performed on each study patient, at least one week apart:
- Treatment for 8 hrs uding 40L of dialysate
- Treatment for 8 hrs using 60L of dialysate
- Treatment for 5 hrs using 40L of dialysate
- Treatment for 5 hrs using 60L of dialysate
Blood samples will be collected and assayed for the concentrations of urea, phosphate, calcium, bicarbonate, beta-2-microglobulin and albumin using standard assays.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Device: NxStage System One (NxStage Medical, Lawrence, MA)Long hemodialysis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Stage V chronic kidney patients with minimal or no residual renal functin
Key exclusion criteria (6 listed)
- Medically unstable
- Hematocrit less than 28%
- Hepatitis B positive, hepatitis C positive or HIV positive
- Pregnant women
- Minors below 18 years of age
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 |
|---|---|---|
| NxStage System One (NxStage Medical, Lawrence, MA)Also: The System One (NxStage Medical, Lawrence, MA)Each patient will be studied on 4 separate occasions. The study sessions are longer than routine daily hemodialysis therapy using the System One. | Device | A |
Primary outcome
the effect of dialysate volume and treatment time on phosphage and calcium removal
Time frame: 4 treatments
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2016.
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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.
Michael Kraus, M.D. principal investigator
Indiana University
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NxStage System One (NxStage Medical, Lawrence, MA) in people with Kidney Failure, run by Indiana University.
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 1 inclusion and 6 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: withdrawn, as of the sponsor's last update on 1 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
the effect of dialysate volume and treatment time on phosphage and calcium removal (time frame: 4 treatments). 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 1 Mar 2016.