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Sponsored by: |
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
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Information provided by: | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
ClinicalTrials.gov Identifier: | NCT00271999 |
The Frequent Hemodialysis (FHN) Nocturnal 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 12 months. Subjects will be randomized to conventional hemodialysis delivered three days per week home arm or to the six times per week nocturnal home hemodialysis arm which will follow any dialysis prescription provided their prescribed standardized Kt/V is at least 4.0 and treatment time is at least 6.0 hours, six times per week.
Condition | Intervention | Phase |
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End Stage Renal Disease Hemodialysis |
Behavioral: Nocturnal home hemodialysis |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Frequent Hemodialysis Network: Nocturnal Trial |
Estimated Enrollment: | 150 |
Study Start Date: | January 2006 |
Estimated Study Completion Date: | January 2010 |
Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Three times a week conventional at home hemodialysis
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Behavioral: Nocturnal home hemodialysis
Six times per week nocturnal home hemodialysis
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2: Experimental
Six times a week nocturnal home hemodialysis
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Behavioral: Nocturnal home hemodialysis
Six times per week nocturnal home hemodialysis
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Paul W. Eggers, Ph.D. | 301-594-8305 | eggersp@extra.niddk.nih.gov |
Contact: Andrew S Narva, M.D. | 301-594-7717 | narvaa@niddk.nih.gov |
United States, North Carolina | |
Wake Forest University - Core center plus other centers in U.S. and Canada | Recruiting |
Winston-Salem, North Carolina, United States, 27157 | |
Contact: Michael V. Rocco, M.D. 336-716-2097 mrocco@wfubmc.edu |
Study Director: | Paul W. Eggers, Ph.D. | NIDDK, NIH |
Principal Investigator: | Michael V. Rocco, M.D. | Wake Forest University |
Principal Investigator: | Gerald J. Beck, Ph.D. | The Cleveland Clinic |
Study Chair: | Alan S. Kliger, M.D. | Hospital of St. Raphael |
Responsible Party: | NIH/NIDDK ( Paul Eggers, Ph.D., Project Officer ) |
Study ID Numbers: | beck-night, 5 U01 DK)66597 |
Study First Received: | January 3, 2006 |
Last Updated: | October 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00271999 |
Health Authority: | United States: Food and Drug Administration |
randomized controlled clinical trial hemodialysis End Stage Renal Disease |
Renal Insufficiency Urologic Diseases Renal Insufficiency, Chronic |
Kidney Failure, Chronic Kidney Diseases Kidney Failure |