Background: Hemodialysis is the majority treatment modality for renal disease, and improvements in its delivery are desperately needed to curb the staggering 20% annual mortality rate for patients with endstage renal failure. Recent physiologic and observational studies have highlighted improved outcomes with more frequent hemodialysis. Clinical trials are now needed to establish the efficacy of this promising treatment. Objectives: The Renal Research Institute/University of Western Ontario Clinical Consortium seeks to conduct a randomized controlled trial of 200 patients comparing short daily 6 times per week hemodialysis (target standard Kt/V of 3.5 +/- 0.5 per week) against conventional 3 times per week hemodialysis (target equilibrated KtN of 1.2 +/- 0.1 per session, approximately equal to a standard Kt/V of 2.2 per week). Patients will be followed for 12 to 18 months.
The aims of this study include: 1) to determine if the improvements in intermediate cardiovascular, social, nutritional, metabolic, and economic outcomes with daily over conventional hemodialysis, which our consortium has documented in observational studies, persist in a randomized controlled trial, 2) to quantify the adverse events and define potential risks associated with short-daily hemodialysis, and 3) to develop ancillary substudies advancing our knowledge of the physiology of daily hemodialysis. Key design elements to this trial include 1) stratification of the randomization by center and patient preference for in center or home hemodialysis, 2) a run in period of 2 weeks on in center daily hemodialysis, 3) careful standardization of specific co-interventions to provide optimal care and to avoid potential bias associated with the unblinded nature of the trial, and 4) statistical methods which account for missing data due to death and transplantation, and the multiple comparisons on intermediate outcomes used in the trial. Implications: This study will guide the feasibility, sample size and cost of a definitive clinical trial, which examines the effectiveness of daily hemodialysis to prevent death and hospitalization.

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Research Project--Cooperative Agreements (U01)
Project #
5U01DK066579-03
Application #
6947718
Study Section
Special Emphasis Panel (ZDK1-GRB-2 (O1))
Program Officer
Eggers, Paul Wayne
Project Start
2003-09-30
Project End
2007-08-31
Budget Start
2005-09-01
Budget End
2006-08-31
Support Year
3
Fiscal Year
2005
Total Cost
$10,000
Indirect Cost
Name
Renal Research Institute (Joint Venture)
Department
Type
DUNS #
931622732
City
New York
State
NY
Country
United States
Zip Code
10128
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
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
Kotanko, Peter; Garg, Amit X; Depner, Tom et al. (2015) Effects of frequent hemodialysis on blood pressure: Results from the randomized frequent hemodialysis network trials. Hemodial Int 19:386-401
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
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