Phosphorus and Calcium Removal During Long Hemodialysis Treatment Sessions (hemodialysis)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2008 by Indiana University.
Recruitment status was Not yet recruiting
Recruitment status was Not yet recruiting
Sponsor:
Indiana University
Information provided by:
Indiana University
ClinicalTrials.gov Identifier:
NCT00633308
First received: February 21, 2008
Last updated: March 11, 2008
Last verified: March 2008
| Tracking Information | |||||||||
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| First Received Date ICMJE | February 21, 2008 | ||||||||
| Last Updated Date | March 11, 2008 | ||||||||
| Start Date ICMJE | March 2008 | ||||||||
| Estimated Primary Completion Date | February 2010 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
the effect of dialysate volume and treatment time on phosphage and calcium removal [ Time Frame: 4 treatments ] [ Designated as safety issue: Yes ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00633308 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Phosphorus and Calcium Removal During Long Hemodialysis Treatment Sessions | ||||||||
| Official Title ICMJE | Phosphorus and Calcium Removal During Long Hemodialysis Treatment Sessions | ||||||||
| Brief 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) |
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| 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:
Blood samples will be collected and assayed for the concentrations of urea, phosphate, calcium, bicarbonate, beta-2-microglobulin and albumin using standard assays. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 2 | ||||||||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Kidney Failure | ||||||||
| Intervention ICMJE | Device: NxStage 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.
Other Name: The System One (NxStage Medical, Lawrence, MA) |
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| Study Arm (s) | Experimental: A
Long hemodialysis
Intervention: Device: NxStage System One (NxStage Medical, Lawrence, MA) |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Not yet recruiting | ||||||||
| Estimated Enrollment ICMJE | 10 | ||||||||
| Estimated Completion Date | February 2011 | ||||||||
| Estimated Primary Completion Date | February 2010 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Not Provided | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00633308 | ||||||||
| Other Study ID Numbers ICMJE | NxStage LongHD | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Michael Kraus, M.D., Indiana University | ||||||||
| Study Sponsor ICMJE | Indiana University | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Indiana University | ||||||||
| Verification Date | March 2008 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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