Frequent Hemodialysis Network: Daily Trial
NCT00264758 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 245
Last updated 2014-07-03
Summary
The Frequent Hemodialysis Network (FHN) Daily Trial is a randomized controlled trial recruiting subjects from dialysis units associated with designated Clinical Centers in the U.S. and Canada and followed for 1 year. Subjects will be randomized to either conventional hemodialysis Daily HD delivered for at least 2.5 hours (typically 3 to 4 hours), 3 days per week, or to more frequent hemodialysis delivered for 1.5 - 2.75 hours, 6 days per week. The study has two co-primary outcomes: 1) a composite of mortality with the change over 12 months in left ventricular mass by magnetic resonance imaging, and 2) a composite of mortality with the change over 12 months in the SF-36 RAND physical health composite (PHC) quality of life scale.
Conditions
Interventions
- DEVICE
-
Conventional hemodialysis
Three times per week in-center hemodialysis
- DEVICE
-
Frequent hemodialysis
Six times per week in-center hemodialysis
Sponsors & Collaborators
-
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
lead NIH
Principal Investigators
-
Paul W. Eggers, Ph.D. · NIDDK, NIH
-
Glenn Chertow, M.D. · University of California, San Francisco
-
Nathan W. Levin, M.D. · Renal Research Institute
-
Gerald J. Beck, Ph.D. · The Cleveland Clinic
-
Alan S. Kliger, M.D. · Yale New Haven Health System
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 13 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2006-01-31
- Primary Completion
- 2010-03-31
- Completion
- 2010-03-31
Countries
- United States
Study Locations
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