Effect of Dialysis Dose and Membrane Flux in Maintenance Hemodialysis

Summary

OBJECTIVES: I. Evaluate whether hemodialysis providing a 2-pool, variable volume urea kinetic modelling value of 1.05 versus 1.45 reduces mortality and morbidity in patients with end stage renal disease.

II. Compare the efficacy of high versus low flux dialyzer membranes.

Conditions

• End Stage Renal Disease

Interventions

DEVICE

Standard dose, low flux hemodialysis

DEVICE

Standard dose, high flux hemodialysis

DEVICE

High dose, low flux hemodialysis

DEVICE

High dose, high flux hemodialysis

Sponsors & Collaborators

• University of Rochester

  collaborator OTHER

• The Cleveland Clinic

  collaborator OTHER

• Tufts Medical Center

  collaborator OTHER

• Vanderbilt University

  collaborator OTHER

• Icahn School of Medicine at Mount Sinai

  collaborator OTHER

• Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

  collaborator OTHER

• Washington University School of Medicine

  collaborator OTHER

• University of Illinois at Chicago

  collaborator OTHER

• Main Line Health

  collaborator OTHER

• Emory University

  collaborator OTHER

• Duke University

  collaborator OTHER

• University of Texas Southwestern Medical Center

  collaborator OTHER

• Brigham and Women's Hospital

  collaborator OTHER

• Wake Forest University Health Sciences

  collaborator OTHER

• University of Utah

  collaborator OTHER

• University of California, Davis

  collaborator OTHER

• University of Alabama at Birmingham

  collaborator OTHER

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

  lead NIH

Principal Investigators

• Daniel B. Ornt · University of Rochester

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

FACTORIAL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

1995-03-31

Primary Completion

2001-12-31

Completion

2001-12-31

FDA Device

Yes

Countries

• United States

Study Locations