Phosphorus and Calcium Removal During Long Hemodialysis Treatment Sessions (hemodialysis)
Primary Purpose
Kidney Failure
Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
NxStage System One (NxStage Medical, Lawrence, MA)
Sponsored by
About this trial
This is an interventional treatment trial for Kidney Failure focused on measuring hemodialysis
Eligibility Criteria
Inclusion Criteria:
- Stage V chronic kidney patients with minimal or no residual renal functin
Exclusion Criteria:
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
A
Arm Description
Long hemodialysis
Outcomes
Primary Outcome Measures
the effect of dialysate volume and treatment time on phosphage and calcium removal
Secondary Outcome Measures
Full Information
NCT ID
NCT00633308
First Posted
February 21, 2008
Last Updated
February 29, 2016
Sponsor
Indiana University
1. Study Identification
Unique Protocol Identification Number
NCT00633308
Brief Title
Phosphorus and Calcium Removal During Long Hemodialysis Treatment Sessions
Acronym
hemodialysis
Official Title
Phosphorus and Calcium Removal During Long Hemodialysis Treatment Sessions
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Withdrawn
Why Stopped
No coordinator available to work on study.
Study Start Date
March 2008 (undefined)
Primary Completion Date
January 2010 (Anticipated)
Study Completion Date
February 2011 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Indiana University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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)
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Failure
Keywords
hemodialysis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Description
Long hemodialysis
Intervention Type
Device
Intervention Name(s)
NxStage System One (NxStage Medical, Lawrence, MA)
Other Intervention Name(s)
The System One (NxStage Medical, Lawrence, MA)
Intervention Description
Each patient will be studied on 4 separate occasions. The study sessions are longer than routine daily hemodialysis therapy using the System One.
Primary Outcome Measure Information:
Title
the effect of dialysate volume and treatment time on phosphage and calcium removal
Time Frame
4 treatments
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Stage V chronic kidney patients with minimal or no residual renal functin
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Kraus, M.D.
Organizational Affiliation
Indiana University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Phosphorus and Calcium Removal During Long Hemodialysis Treatment Sessions
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