The Frequent Hemodialysis Network (FHN) Study is a randomized clinical trial designed to test hypotheses related to the feasibility, safety, and efficacy of frequent (6x per week) vs. conventional (3x per week) hemodialysis. The recently completed NIDDK-funded MEMO 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 125 subjects (adults and children) as requested by the RFA. Subject recruitment, retention and adherence have been excellent;plans are in place to augment recruitment at existing sites by approaching additional local dialysis facilities and to expand recruitment to VA medical centers affiliated with participating universities. The sample size will not be sufficient to demonstrate a difference in survival among groups. Safety and clinical events (e.g., hospitalization) will continue to be carefully tracked. With continued enrollment and randomization, the study should have sufficient power to detect clinically meaningful differences in the co-primary outcomes (the composite of mortality and change in left ventricular mass;and the composite of mortality and change in the Physical Health Composite of the SF-36). The study should also have sufficient power to detect clinically meaningful differences in other secondary outcomes. Dr. Chertow and his colleages have assembled a talented group of investigators and coordinators. The consortium has worked effectively with multiple industry partners. We are collectively committed to working cooperatively and constructively with the other CCC and DCC to reach all FHN study goals.

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Research Project--Cooperative Agreements (U01)
Project #
5U01DK066481-08
Application #
7934040
Study Section
Special Emphasis Panel (ZDK1-GRB-N (J1))
Program Officer
Eggers, Paul Wayne
Project Start
2003-09-30
Project End
2013-01-31
Budget Start
2010-02-01
Budget End
2013-01-31
Support Year
8
Fiscal Year
2010
Total Cost
$350,000
Indirect Cost
Name
Stanford University
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
009214214
City
Stanford
State
CA
Country
United States
Zip Code
94305
Chan, Christopher T; Kaysen, George A; Beck, Gerald J et al. (2018) Changes in Biomarker Profile and Left Ventricular Hypertrophy Regression: Results from the Frequent Hemodialysis Network Trials. Am J Nephrol 47:208-217
Lo, Joan C; Beck, Gerald J; Kaysen, George A et al. (2017) Thyroid function in end stage renal disease and effects of frequent hemodialysis. Hemodial Int 21:534-541
Garg, Amit X; Suri, Rita S; Eggers, Paul et al. (2017) Patients receiving frequent hemodialysis have better health-related quality of life compared to patients receiving conventional hemodialysis. Kidney Int 91:746-754
Ferrario, Manuela; Raimann, Jochen G; Larive, Brett et al. (2015) Non-Linear Heart Rate Variability Indices in the Frequent Hemodialysis Network Trials of Chronic Hemodialysis Patients. Blood Purif 40:99-108
Chan, Christopher T; Chertow, Glenn M; Daugirdas, John T et al. (2014) Effects of daily hemodialysis on heart rate variability: results from the Frequent Hemodialysis Network (FHN) Daily Trial. Nephrol Dial Transplant 29:168-78
Achinger, Steven G; Ikizler, T Alp; Bian, Aihua et al. (2013) Long-term effects of daily hemodialysis on vascular access outcomes: a prospective controlled study. Hemodial Int 17:208-15
Sergeyeva, Olga; Gorodetskaya, Irina; Ramos, Rosio et al. (2012) Challenges to enrollment and randomization of the Frequent Hemodialysis Network (FHN) Daily Trial. J Nephrol 25:302-9
Hall, Yoshio N; Choi, Andy I; Xu, Ping et al. (2011) Racial ethnic differences in rates and determinants of deceased donor kidney transplantation. J Am Soc Nephrol 22:743-51
Hall, Yoshio N; Xu, Ping; Chertow, Glenn M (2011) Relationship of body size and mortality among US Asians and Pacific Islanders on dialysis. Ethn Dis 21:40-6
Rocco, Michael V; Larive, Brett; Eggers, Paul W et al. (2011) Baseline characteristics of participants in the Frequent Hemodialysis Network (FHN) daily and nocturnal trials. Am J Kidney Dis 57:90-100

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