This is an application from the Department of Medicine, Divisions of Nephrology and Hematology, and the Department of Surgery at the Duke University Medical Center to participate as a clinical center in the NIH- sponsored Hemodialysis Vascular Access Clinical Trials Consortium. The proposed trial is a randomized prospective evaluation of a series of novel agents such as (Elmiron(R) pentosan polsulfonate sodium see appendix A, or Tissue Factor Pathway Inhibitor TFPI see appendix A or other novel interventional agent) versus placebo in the prevention of hemodialysis vascular access stenosis and thrombosis in hemodialysis AV access. Patients will be randomized to therapy with Elmiron(R) (or other trial agent) versus placebo. Randomization criteria will include whether this is a first or a subsequent AV graft as well as graft location and the presence or absence of diabetes mellitus. All patients entering the study will be screened with AV access flow, determined by the ultrasound dilution technique. Grafts with initial flows less than 1000 ml/min will not be randomized. Patients will be prospectively followed with monthly measurements of hemodialysis vascular access flow by ultrasound dilution. Decrements in AV access flow greater than 25% will prompt evaluation by venography. The primary end point in the study will be the development of a greater than 50% stenosis as determined by biplanar venography when associated with a concurrent flow decrement. All episodes of Access thrombosis will also serve as primary endpoints. Secondary end points will include all other AV access complications and hospitalizations. Ancillary studies will include response of AV access to intervention, access patency, and the cost of the placebo and intervention arms of the study.

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Research Project--Cooperative Agreements (U01)
Project #
5U01DK058985-04
Application #
6654999
Study Section
Special Emphasis Panel (ZDK1-GRB-2 (O2))
Program Officer
Kusek, John W
Project Start
2000-09-30
Project End
2005-02-28
Budget Start
2003-08-01
Budget End
2004-02-29
Support Year
4
Fiscal Year
2003
Total Cost
$288,723
Indirect Cost
Name
Duke University
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
044387793
City
Durham
State
NC
Country
United States
Zip Code
27705
Dixon, Bradley S; Beck, Gerald J; Dember, Laura M et al. (2011) Use of aspirin associates with longer primary patency of hemodialysis grafts. J Am Soc Nephrol 22:773-81
Dixon, Bradley S; Beck, Gerald J; Vazquez, Miguel A et al. (2009) Effect of dipyridamole plus aspirin on hemodialysis graft patency. N Engl J Med 360:2191-201
Dember, Laura M; Beck, Gerald J; Allon, Michael et al. (2008) Effect of clopidogrel on early failure of arteriovenous fistulas for hemodialysis: a randomized controlled trial. JAMA 299:2164-71
Dixon, Bradley S; Beck, Gerald J; Dember, Laura M et al. (2005) Design of the Dialysis Access Consortium (DAC) Aggrenox Prevention Of Access Stenosis Trial. Clin Trials 2:400-12
Dember, Laura M; Kaufman, James S; Beck, Gerald J et al. (2005) Design of the Dialysis Access Consortium (DAC) Clopidogrel Prevention of Early AV Fistula Thrombosis Trial. Clin Trials 2:413-22