Status:
COMPLETED
Study of How the Dose of Dialysis is Affected by Dialysate Flow Rate
Lead Sponsor:
Vantive Health LLC
Collaborating Sponsors:
University of Louisville
Vanderbilt University Medical Center
Conditions:
Chronic Kidney Disease
Chronic Renal Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to look at how the dose of dialysis is affected by the rate at which dialysate flows through the dialyzer. The dose of dialysis (Kt/V) will be determined by measuring bloo...
Eligibility Criteria
Inclusion
- Adult subject ≥18 years of age undergoing chronic hemodialysis for end- stage renal disease (ESRD) three times a week for at least three months with a stable treatment prescription
- Subject has no hospitalizations in previous three months for a significant illness related to a renal or dialysis problem except for vascular access surgery
- Subject with an AV fistula or graft capable of routinely delivering a blood flow rate of 400 mL/min
Exclusion
- Subject who is non-compliant with dialysis prescription
- Subject whose hemodialysis schedule is not three times a week
- Subject using a catheter for blood access
- Subject who is not anticoagulated with heparin during hemodialysis
- Subject with a current malignancy involving sites other than skin
- Subject with a history of drug or alcohol abuse within the last six months
- Subject who is believed to be unable to complete the entire study (e.g., due to a concurrent disease, life expectancy of less than a year, or scheduled kidney transplant
- Subject who is pregnant
- Subject who is considered incompetent to give an informed consent
- Subject with a positive test for hepatitis B surface antigen within the past 30 days (testing for hepatitis B surface antigen is not required for subjects who have tested positive for hepatitis B antibody within the past year and any such patients will not be subject to this exclusion criterion)
- Subject with known HIV infection (if this is not known, no HIV testing will be performed
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT00962000
Start Date
September 1 2009
End Date
June 1 2010
Last Update
July 24 2025
Active Locations (3)
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1
University of California Davis
Sacramento, California, United States, 95817-1460
2
University of Louisville
Louisville, Kentucky, United States, 40202
3
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232-2372