We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effect of Dialysis Dose and Membrane Flux in Maintenance Hemodialysis (HEMO)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00004285
First Posted: October 19, 1999
Last Update Posted: September 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
University of Rochester
The Cleveland Clinic
Tufts Medical Center
Vanderbilt University
Icahn School of Medicine at Mount Sinai
Los Angeles Biomedical Research Institute
Washington University School of Medicine
University of Illinois at Chicago
Main Line Health
Emory University
Duke University
University of Texas Southwestern Medical Center
Brigham and Women's Hospital
Wake Forest University Health Sciences
University of Utah
University of California, Davis
University of Alabama at Birmingham
Information provided by (Responsible Party):
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
October 18, 1999
October 19, 1999
September 14, 2017
March 1995
December 31, 2001   (Final data collection date for primary outcome measure)
Death from any cause [ Time Frame: 5 years ]
Not Provided
Complete list of historical versions of study NCT00004285 on ClinicalTrials.gov Archive Site
  • First hospitalization for cardiac causes or death from any cause [ Time Frame: 5 years ]
  • First hospitalization for infection or death from any cause [ Time Frame: 5 years ]
  • First >15% decrease in albumin or death from any cause [ Time Frame: 5 years ]
  • All hospitalizations not related to vascular access [ Time Frame: 5 years ]
  • Death due to cardiac causes [ Time Frame: 5 years ]
  • First hospitalization or death due to cardiac causes [ Time Frame: 5 years ]
  • Death due to infection [ Time Frame: 5 years ]
  • First hospitalization or death due to infection [ Time Frame: 5 years ]
Not Provided
Not Provided
Not Provided
 
Effect of Dialysis Dose and Membrane Flux in Maintenance Hemodialysis
Randomized Study of Standard vs High Amount of Hemodialysis Using Low vs High Flux Dialyzer Membranes for End Stage Renal Disease

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.

PROTOCOL OUTLINE: This is a randomized, multicenter study. Patients are stratified by center, age, and diabetes prior to dialysis initiation.

Patients are randomly assigned to 1 of 4 groups: moderate dose dialysis, low flux membrane; high dose dialysis, low flux membrane; moderate dose dialysis, high flux membrane; or high dose dialysis, high flux membrane. Moderate dose is a target eKt/V of 1.05 and high dose is 1.45. The dose and delivery of dialysis are measured monthly by the equilibrated fractional clearance of urea (eKt/V) calculated with double pool kinetics.

Patients are dialyzed 3 times a week in the shortest possible time (minimum 2.5 hours), adjusted for adequate fluid removal. General medical care, protein and calorie intake, and dialyzer reuse and other aspects of dialysis therapy are standardized. The protocol document lists approved dialyzers; no unsubstituted cellulosic membranes are permitted.

The intervention phase of this study is 5 years. Patients are followed for survival.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
End Stage Renal Disease
  • Device: Standard dose, low flux hemodialysis
  • Device: Standard dose, high flux hemodialysis
  • Device: High dose, low flux hemodialysis
  • Device: High dose, high flux hemodialysis
  • Active Comparator: Standard dose, low flux hemodialysis
    Intervention: Device: Standard dose, low flux hemodialysis
  • Experimental: Standard dose, high flux hemodialysis
    Intervention: Device: Standard dose, high flux hemodialysis
  • Experimental: High dose, low flux hemodialysis
    Intervention: Device: High dose, low flux hemodialysis
  • Experimental: High dose, high flux hemodialysis
    Intervention: Device: High dose, high flux hemodialysis

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1846
December 31, 2001
December 31, 2001   (Final data collection date for primary outcome measure)

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

  • End stage renal disease that requires in-center hemodialysis 3 times/week On hemodialysis for at least 3 months (6 months following renal transplant)
  • No scheduled renal transplant from living donor

--Prior/Concurrent Therapy--

  • No concurrent intervention studies unless ancillary to this protocol No concurrent investigational drugs

--Patient Characteristics--

  • Hepatic: Albumin at least 2.6 g/dL by nephelometry No cirrhosis with encephalopathy or abnormal PT
  • Renal: Urea clearance (interdialytic) no greater than 1.5 mL/min per 35 liters total urea volume
  • Cardiovascular: No New York Heart Association class IV congestive heart failure despite maximal therapy No unstable angina No new onset angina No recent exacerbation of frequency, duration, or severity of angina
  • Pulmonary: No chronic pulmonary disease requiring supplemental oxygen
  • Other: Not hospitalized in acute or long term care facility at entry No active malignancy requiring chemotherapy or radiotherapy No AIDS No active systemic infection, e.g., tuberculosis or fungal infection No mental incompetence or other contraindication to protocol therapy Not pregnant Geographically available for treatment at participating institution No more than 20 missed treatments/year
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00004285
199/11704
U01DK046109 ( U.S. NIH Grant/Contract )
U01DK046114 ( U.S. NIH Grant/Contract )
U01DK046126 ( U.S. NIH Grant/Contract )
U01DK046140 ( U.S. NIH Grant/Contract )
U01DK046143 ( U.S. NIH Grant/Contract )
U01DK049240 ( U.S. NIH Grant/Contract )
U01DK049241 ( U.S. NIH Grant/Contract )
U01DK049242 ( U.S. NIH Grant/Contract )
U01DK049243 ( U.S. NIH Grant/Contract )
U01DK049244 ( U.S. NIH Grant/Contract )
U01DK049249 ( U.S. NIH Grant/Contract )
U01DK049252 ( U.S. NIH Grant/Contract )
U01DK049254 ( U.S. NIH Grant/Contract )
U01DK049259 ( U.S. NIH Grant/Contract )
U01DK049261 ( U.S. NIH Grant/Contract )
U01DK049264 ( U.S. NIH Grant/Contract )
U01DK049271 ( U.S. NIH Grant/Contract )
Yes
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Plan to Share IPD: Yes
Plan Description: Data and samples are available at the NIDDK central repository
Supporting Materials: Study Protocol
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: Analytic Code
Time Frame: Available since 2009
URL: https://www.niddkrepository.org/studies/hemo/?query=hemo
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • University of Rochester
  • The Cleveland Clinic
  • Tufts Medical Center
  • Vanderbilt University
  • Icahn School of Medicine at Mount Sinai
  • Los Angeles Biomedical Research Institute
  • Washington University School of Medicine
  • University of Illinois at Chicago
  • Main Line Health
  • Emory University
  • Duke University
  • University of Texas Southwestern Medical Center
  • Brigham and Women's Hospital
  • Wake Forest University Health Sciences
  • University of Utah
  • University of California, Davis
  • University of Alabama at Birmingham
Study Chair: Daniel B. Ornt University of Rochester
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP