Frequent Hemodialysis Network: Daily Trial

NCT00264758 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 245

Last updated 2014-07-03

No results posted yet for this study

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00264758 on ClinicalTrials.gov