BACKGROUND: The annual mortality rate for maintenance hemodialysis patients in the United States is unacceptably high at 15%-20%. In 2004, we initiated the Frequent Hemodialysis Network (FHN) clinical trials. This report presents baseline characteristics of FHN Trial participants and compares them with hemodialysis patients tracked in US Renal Data System (USRDS) data. STUDY DESIGN: 2 separate randomized clinical trials. SETTINGS & PARTICIPANTS: FHN includes 332 patients with chronic kidney disease requiring long-term dialysis therapy enrolled in 2 separate randomized clinical trials. The FHN Daily Trial (245 randomly assigned participants) was designed to compare outcomes of 6-times-weekly in-center daily hemodialysis (1.5-2.75 h/session) with conventional 3-times-weekly in-center hemodialysis. The FHN Nocturnal Trial (87 randomly assigned participants) was designed to compare outcomes of 6-times-weekly home nocturnal (6-8 h/session) with conventional 3-times-weekly hemodialysis. USRDS data include 338,109 incident and prevalent long-term hemodialysis patients from the calendar year 2007. RESULTS:Participants in both trials were on average younger than the average hemodialysis patient in the United States (Daily Trial, 50.4 years; P < 0.001; Nocturnal Trial, 52.8 years; P < 0.001). Compared with USRDS data, whites were under-represented in the Daily Trial (36% vs 55%; P < 0.001), whereas Hispanics were under-represented in the Nocturnal Trial and over-represented in the Daily Trial (0% vs 28%; P < 0.001). In addition, there were more fistulas and fewer catheters in the Daily Trial (61% and 20%, respectively; P < 0.001 for both) and fewer grafts and more catheters in the Nocturnal Trial (10% and 44%, respectively; P < 0.005 for both). LIMITATIONS: Clinical trial exclusion criteria and patient willingness to participate limit comparisons with the USRDS. CONCLUSIONS:FHN participants were younger and the racial composition for each study was different from the racial composition of the aggregate US dialysis population. Catheters for vascular access were more common in FHN Nocturnal Trial participants.
RCT Entities:
BACKGROUND: The annual mortality rate for maintenance hemodialysis patients in the United States is unacceptably high at 15%-20%. In 2004, we initiated the Frequent Hemodialysis Network (FHN) clinical trials. This report presents baseline characteristics of FHN Trial participants and compares them with hemodialysis patients tracked in US Renal Data System (USRDS) data. STUDY DESIGN: 2 separate randomized clinical trials. SETTINGS & PARTICIPANTS: FHN includes 332 patients with chronic kidney disease requiring long-term dialysis therapy enrolled in 2 separate randomized clinical trials. The FHN Daily Trial (245 randomly assigned participants) was designed to compare outcomes of 6-times-weekly in-center daily hemodialysis (1.5-2.75 h/session) with conventional 3-times-weekly in-center hemodialysis. The FHN Nocturnal Trial (87 randomly assigned participants) was designed to compare outcomes of 6-times-weekly home nocturnal (6-8 h/session) with conventional 3-times-weekly hemodialysis. USRDS data include 338,109 incident and prevalent long-term hemodialysis patients from the calendar year 2007. RESULTS:Participants in both trials were on average younger than the average hemodialysis patient in the United States (Daily Trial, 50.4 years; P < 0.001; Nocturnal Trial, 52.8 years; P < 0.001). Compared with USRDS data, whites were under-represented in the Daily Trial (36% vs 55%; P < 0.001), whereas Hispanics were under-represented in the Nocturnal Trial and over-represented in the Daily Trial (0% vs 28%; P < 0.001). In addition, there were more fistulas and fewer catheters in the Daily Trial (61% and 20%, respectively; P < 0.001 for both) and fewer grafts and more catheters in the Nocturnal Trial (10% and 44%, respectively; P < 0.005 for both). LIMITATIONS: Clinical trial exclusion criteria and patient willingness to participate limit comparisons with the USRDS. CONCLUSIONS: FHN participants were younger and the racial composition for each study was different from the racial composition of the aggregate US dialysis population. Catheters for vascular access were more common in FHN Nocturnal Trialparticipants.
Authors: Rita S Suri; Gihad E Nesrallah; Rahul Mainra; Amit X Garg; Robert M Lindsay; Tom Greene; John T Daugirdas Journal: Clin J Am Soc Nephrol Date: 2005-11-16 Impact factor: 8.237
Authors: R S Suri; A X Garg; G M Chertow; N W Levin; M V Rocco; T Greene; G J Beck; J J Gassman; P W Eggers; R A Star; D B Ornt; A S Kliger Journal: Kidney Int Date: 2006-12-13 Impact factor: 10.612
Authors: Michael V Rocco; Johanna T Dwyer; Brett Larive; Tom Greene; David B Cockram; W Cameron Chumlea; John W Kusek; June Leung; Jerrilynn D Burrowes; Sandy L McLeroy; Diane Poole; Leigh Uhlin Journal: Kidney Int Date: 2004-06 Impact factor: 10.612
Authors: Mark Unruh; Robert Benz; Tom Greene; Guofen Yan; Srinivasan Beddhu; Maria DeVita; Johanna T Dwyer; Paul L Kimmel; John W Kusek; Alice Martin; Josephine Rehm-McGillicuddy; Brendan P Teehan; Klemens B Meyer Journal: Kidney Int Date: 2004-07 Impact factor: 10.612
Authors: Garabed Eknoyan; Gerald J Beck; Alfred K Cheung; John T Daugirdas; Tom Greene; John W Kusek; Michael Allon; James Bailey; James A Delmez; Thomas A Depner; Johanna T Dwyer; Andrew S Levey; Nathan W Levin; Edgar Milford; Daniel B Ornt; Michael V Rocco; Gerald Schulman; Steve J Schwab; Brendan P Teehan; Robert Toto Journal: N Engl J Med Date: 2002-12-19 Impact factor: 91.245
Authors: Glenn M Chertow; Nathan W Levin; Gerald J Beck; John T Daugirdas; Paul W Eggers; Alan S Kliger; Brett Larive; Michael V Rocco; Tom Greene Journal: J Am Soc Nephrol Date: 2015-10-14 Impact factor: 10.121
Authors: Christopher T Chan; George A Kaysen; Gerald J Beck; Minwei Li; Joan Lo; Michael V Rocco; Alan S Kliger Journal: Am J Nephrol Date: 2018-04-05 Impact factor: 3.754
Authors: Peter Kotanko; Amit X Garg; Tom Depner; Andreas Pierratos; Christopher T Chan; Nathan W Levin; Tom Greene; Brett Larive; Gerald J Beck; Jennifer Gassman; Alan S Kliger; John B Stokes Journal: Hemodial Int Date: 2015-01-05 Impact factor: 1.812
Authors: Yoshio N Hall; Brett Larive; Patricia Painter; George A Kaysen; Robert M Lindsay; Allen R Nissenson; Mark L Unruh; Michael V Rocco; Glenn M Chertow Journal: Clin J Am Soc Nephrol Date: 2012-03-15 Impact factor: 8.237
Authors: Christopher T Chan; Tom Greene; Glenn M Chertow; Alan S Kliger; John B Stokes; Gerald J Beck; John T Daugirdas; Peter Kotanko; Brett Larive; Nathan W Levin; Ravindra L Mehta; Michael Rocco; Javier Sanz; Brigitte M Schiller; Phillip C Yang; Sanjay Rajagopalan Journal: Circ Cardiovasc Imaging Date: 2012-02-23 Impact factor: 7.792
Authors: Amit X Garg; Rita S Suri; Paul Eggers; Fredric O Finkelstein; Tom Greene; Paul L Kimmel; Alan S Kliger; Brett Larive; Robert M Lindsay; Andreas Pierratos; Mark Unruh; Glenn M Chertow Journal: Kidney Int Date: 2017-01-13 Impact factor: 10.612
Authors: Jochen G Raimann; Samer R Abbas; Li Liu; Fansan Zhu; Brett Larive; Peter Kotanko; Nathan W Levin; George A Kaysen Journal: Nephron Clin Pract Date: 2014-11-07
Authors: Charles Chazot; Ken Farrington; Ionut Nistor; Wim Van Biesen; Hanneke Joosten; Daniel Teta; Dimitrie Siriopol; Adrian Covic Journal: Int Urol Nephrol Date: 2015-09-16 Impact factor: 2.370
Authors: Mark L Unruh; Brett Larive; Paul W Eggers; Amit X Garg; Jennifer J Gassman; Fredric O Finkelstein; Paul L Kimmel; Glenn M Chertow Journal: Nephrol Dial Transplant Date: 2016-04-15 Impact factor: 5.992
Authors: Mark L Unruh; Brett Larive; Glenn M Chertow; Paul W Eggers; Amit X Garg; Jennifer Gassman; Maria Tarallo; Fredric O Finkelstein; Paul L Kimmel Journal: Am J Kidney Dis Date: 2013-01-15 Impact factor: 8.860