FREEDOM - Frequent Dialysis Outcomes & Markers Study

Summary

Principal Investigator: G M Chertow
Affiliation: University of California
Country: USA
Abstract: The FREEDOM (Frequent Dialysis Outcomes & Markers) Study is a randomized clinical trial designed to test hypotheses related to the feasibility, safety, and efficacy of frequent (>3 times per week) hemodialysis. The recently completed NIDDK-funded HEMO Study demonstrated that survival and many other outcomes were not appreciably influenced by significant increases in equilibrated Kt/Vurea, a parameter of dialysis dose, when hemodialysis was given thrice weekly. Clinical experience and published anecdotal reports suggest that more frequent dialysis may result in reduced frequency and duration of hospitalization, improved control of volume overload, hypertension and anemia, correction of disorders of mineral metabolism, and enhanced quality of life. Given the high mortality rates and significant morbidity associated with end-stage renal disease, a rigorous evaluation of alternative dialysis strategies is warranted. The Investigators have constructed a consortium of University- and community-based nephrologists and dialysis units throughout the state of California - the California Coordinating Clinical Center (CCC). We serve urban and suburban communities with extensive racial, ethnic and socioeconomic diversity. We intend on enrolling 200 subjects {adults and children) as requested by the RFA with a "recruit to replace" strategy to maximize the information gained and resources utilized. Subjects will be randomized in a 1:1:1:1 ratio to hemodialysis three, four, five, or six days per week, with dialysis efficiency targets kept equivalent on a per treatment basis. We will work closely with the General Clinical Research Centers at UCSF, UCLA, and UC San Diego. The sample size will not be sufficient to demonstrate a difference in survival among groups. However, the study should have sufficient power to detect significant differences in several of the planned safety and efficacy outcomes and measures. The California CCC Investigators and Consultants have considerable expertise in many of the selected outcomes and measures, including vascular access, nutritional status, vascular calcification, inflammation and oxidative stress, physical function, cognitive function, quality of life, depression, mineral metabolism, bone density and dynamics, anemia, and dialysis dose quantification. We are committed to working cooperatively and constructively with the other CCC and Data Analysis Coordinating Center-regardless of the final agreed-upon protocol.
Funding Period: 2003-09-30 - 2007-09-30
more information: NIH RePORT

Top Publications

  1. ncbi Phosphorus balance and mineral metabolism with 3 h daily hemodialysis
    J C Ayus
    Texas Diabetes Institute, Bexar County Hospital District, San Antonio, Texas 78207, USA
    Kidney Int 71:336-42. 2007
  2. ncbi Neighborhood poverty and kidney transplantation among US Asians and Pacific Islanders with end-stage renal disease
    Y N Hall
    Department of Medicine, University of Washington, Seattle, WA, USA
    Am J Transplant 8:2402-9. 2008
  3. ncbi Characteristics of uninsured Americans with chronic kidney disease
    Yoshio N Hall
    Veterans Affairs Puget Sound Health Care System, 1660 S Columbian Way, 111M, Seattle, WA 98108, USA
    J Gen Intern Med 24:917-22. 2009
  4. ncbi Transplant nephrectomy improves survival following a failed renal allograft
    Juan Carlos Ayus
    Department of Clinical Research, Renal Consultants of Houston, 2412 Westgate Street, Houston, TX, USA
    J Am Soc Nephrol 21:374-80. 2010

Scientific Experts

  • Juan Carlos Ayus
  • Y N Hall
  • Juan Carlos Ayus
  • J C Ayus
  • Steven G Achinger
  • Alan S Go
  • Mohamed H Sayegh
  • Shuko Lee
  • M R Mizani
  • S G Achinger
  • G M Chertow
  • S Lee
  • W Furmaga
  • F Rodriguez

Detail Information

Publications4

  1. ncbi Phosphorus balance and mineral metabolism with 3 h daily hemodialysis
    J C Ayus
    Texas Diabetes Institute, Bexar County Hospital District, San Antonio, Texas 78207, USA
    Kidney Int 71:336-42. 2007
    ..The net effect allows for improved achievement of mineral metabolism goals...
  2. ncbi Neighborhood poverty and kidney transplantation among US Asians and Pacific Islanders with end-stage renal disease
    Y N Hall
    Department of Medicine, University of Washington, Seattle, WA, USA
    Am J Transplant 8:2402-9. 2008
    ..Our findings call for studies to identify cultural and local barriers to transplant among Asians and Pacific Islanders, particularly those residing in resource-poor neighborhoods...
  3. ncbi Characteristics of uninsured Americans with chronic kidney disease
    Yoshio N Hall
    Veterans Affairs Puget Sound Health Care System, 1660 S Columbian Way, 111M, Seattle, WA 98108, USA
    J Gen Intern Med 24:917-22. 2009
    ..Little is known about the extent of health insurance coverage for persons with non-dialysis dependent chronic kidney disease (CKD)...
  4. ncbi Transplant nephrectomy improves survival following a failed renal allograft
    Juan Carlos Ayus
    Department of Clinical Research, Renal Consultants of Houston, 2412 Westgate Street, Houston, TX, USA
    J Am Soc Nephrol 21:374-80. 2010
    ..In conclusion, within a large, nationally representative sample of high-risk patients returning to long-term dialysis after failed kidney transplant, receipt of allograft nephrectomy independently associated with improved survival...