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. pmc Effects of daily hemodialysis on heart rate variability: results from the Frequent Hemodialysis Network (FHN) Daily Trial
    Christopher T Chan
    University Health Network, Toronto, Canada
    Nephrol Dial Transplant 29:168-78. 2014
  2. pmc Long-term effects of daily hemodialysis on vascular access outcomes: a prospective controlled study
    Steven G Achinger
    Department of Nephrology, Watson Clinic, LLP Lakeland, FL, USA
    Hemodial Int 17:208-15. 2013
  3. pmc Reexploring differences among for-profit and nonprofit dialysis providers
    Donald K K Lee
    School of Mangement, Yale Univeristy, New Haven, CT
    Health Serv Res 45:633-46. 2010
  4. pmc Chronic kidney disease in the urban poor
    Yoshio N Hall
    Kidney Research Institute, University of Washington, 325 Ninth Avenue, Box 359606, Seattle, WA 98104, USA
    Clin J Am Soc Nephrol 5:828-35. 2010
  5. doi Challenges to enrollment and randomization of the Frequent Hemodialysis Network (FHN) Daily Trial
    Olga Sergeyeva
    Renal Research Institute, New York, NY 10128, USA
    J Nephrol 25:302-9. 2012
  6. pmc Relationship of body size and mortality among US Asians and Pacific Islanders on dialysis
    Yoshio N Hall
    Department of Medicine, University of Washington, Seattle, USA
    Ethn Dis 21:40-6. 2011
  7. pmc Racial ethnic differences in rates and determinants of deceased donor kidney transplantation
    Yoshio N Hall
    University of Washington, Kidney Research Institute, Department of Medicine, 325 9th Avenue, Box 359606, Seattle, WA 98104, USA
    J Am Soc Nephrol 22:743-51. 2011
  8. pmc Baseline characteristics of participants in the Frequent Hemodialysis Network (FHN) daily and nocturnal trials
    Michael V Rocco
    Department of Medicine, Wake Forest University School of Medicine, Winston Salem, NC 27157 1053, USA
    Am J Kidney Dis 57:90-100. 2011
  9. ncbi Use of 3-hour daily hemodialysis and paricalcitol in patients with severe secondary hyperparathyroidism: A case series
    Steven G Achinger
    Physicians Clinical Research, San Antonio, Texas, USA
    Hemodial Int 14:193-9. 2010
  10. pmc 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

Scientific Experts

  • Y N Hall
  • Juan Carlos Ayus
  • M V Rocco
  • Steven G Achinger
  • Glenn M Chertow
  • Juan Carlos Ayus
  • Christopher T Chan
  • Brett Larive
  • Olga Sergeyeva
  • Donald K K Lee
  • J C Ayus
  • John B Stokes
  • Peter Kotanko
  • John T Daugirdas
  • Andreas Pierratos
  • Tom H Greene
  • T Alp Ikizler
  • Ayumi Shintani
  • Aihua Bian
  • Irina Gorodetskaya
  • Nathan W Levin
  • Jochen G Raimann
  • Paul W Eggers
  • Rosio Ramos
  • Brigitte M Schiller
  • Frequent Hemodialysis Network Trials Group
  • George O Ting
  • Alan S Go
  • Stefanos A Zenios
  • Mohammed R Mizani
  • Mohamed H Sayegh
  • Juan C Ayus
  • Shuko Lee
  • M R Mizani
  • S G Achinger
  • G M Chertow
  • S Lee
  • W Furmaga
  • F Rodriguez

Detail Information

Publications14

  1. pmc Effects of daily hemodialysis on heart rate variability: results from the Frequent Hemodialysis Network (FHN) Daily Trial
    Christopher T Chan
    University Health Network, Toronto, Canada
    Nephrol Dial Transplant 29:168-78. 2014
    ..We hypothesized that daily in-center hemodialysis (HD) would increase HRV...
  2. pmc Long-term effects of daily hemodialysis on vascular access outcomes: a prospective controlled study
    Steven G Achinger
    Department of Nephrology, Watson Clinic, LLP Lakeland, FL, USA
    Hemodial Int 17:208-15. 2013
    ..99 95% CI: 0.42, 2.36, P = 0.96). Daily hemodialysis is not associated with increased vascular access complications, or increased vascular access failure rates...
  3. pmc Reexploring differences among for-profit and nonprofit dialysis providers
    Donald K K Lee
    School of Mangement, Yale Univeristy, New Haven, CT
    Health Serv Res 45:633-46. 2010
    ..To determine whether profit status is associated with differences in hospital days per patient, an outcome that may also be influenced by provider financial goals...
  4. pmc Chronic kidney disease in the urban poor
    Yoshio N Hall
    Kidney Research Institute, University of Washington, 325 Ninth Avenue, Box 359606, Seattle, WA 98104, USA
    Clin J Am Soc Nephrol 5:828-35. 2010
    ..The primary study objectives were to describe patient characteristics, incident ESRD, and mortality in adults with nondialysis-dependent CKD receiving care in the health care safety net...
  5. doi Challenges to enrollment and randomization of the Frequent Hemodialysis Network (FHN) Daily Trial
    Olga Sergeyeva
    Renal Research Institute, New York, NY 10128, USA
    J Nephrol 25:302-9. 2012
    ..Herein we report challenges to enrollment and randomization into the trial...
  6. pmc Relationship of body size and mortality among US Asians and Pacific Islanders on dialysis
    Yoshio N Hall
    Department of Medicine, University of Washington, Seattle, USA
    Ethn Dis 21:40-6. 2011
    ..Our study objective was to compare the relations of body size and mortality among patients with end-stage renal disease of different ethnicities...
  7. pmc Racial ethnic differences in rates and determinants of deceased donor kidney transplantation
    Yoshio N Hall
    University of Washington, Kidney Research Institute, Department of Medicine, 325 9th Avenue, Box 359606, Seattle, WA 98104, USA
    J Am Soc Nephrol 22:743-51. 2011
    ..Area-based efforts targeted to address racial- and ethnic-specific delays in transplantation may help to reduce overall disparities in deceased donor kidney transplantation in the United States...
  8. pmc Baseline characteristics of participants in the Frequent Hemodialysis Network (FHN) daily and nocturnal trials
    Michael V Rocco
    Department of Medicine, Wake Forest University School of Medicine, Winston Salem, NC 27157 1053, USA
    Am J Kidney Dis 57:90-100. 2011
    ..This report presents baseline characteristics of FHN Trial participants and compares them with hemodialysis patients tracked in US Renal Data System (USRDS) data...
  9. ncbi Use of 3-hour daily hemodialysis and paricalcitol in patients with severe secondary hyperparathyroidism: A case series
    Steven G Achinger
    Physicians Clinical Research, San Antonio, Texas, USA
    Hemodial Int 14:193-9. 2010
    ..0001), and a 17.6% increase in serum calcium (8.18 +/- 2.04-9.62 +/- 0.93 mg/dL, P<0.01). Three-hour daily hemodialysis with the use of high-dose paricalcitol is associated with improved control of severe secondary hyperparathyroidism...
  10. pmc 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)...
  11. pmc 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...
  12. 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...
  13. 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...