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

This study has been completed.
Sponsor:
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)
ClinicalTrials.gov Identifier:
NCT00004285
First received: October 18, 1999
Last updated: September 13, 2017
Last verified: September 2017
  Purpose

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.


Condition Intervention
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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Study of Standard vs High Amount of Hemodialysis Using Low vs High Flux Dialyzer Membranes for End Stage Renal Disease

Resource links provided by NLM:


Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Primary Outcome Measures:
  • Death from any cause [ Time Frame: 5 years ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 1846
Actual Study Start Date: March 1995
Study Completion Date: December 31, 2001
Primary Completion Date: December 31, 2001 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Standard dose, low flux hemodialysis Device: Standard dose, low flux hemodialysis
Experimental: Standard dose, high flux hemodialysis Device: Standard dose, high flux hemodialysis
Experimental: High dose, low flux hemodialysis Device: High dose, low flux hemodialysis
Experimental: High dose, high flux hemodialysis Device: High dose, high flux hemodialysis

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004285

Locations
United States, New York
University of Rochester School of Medicine
Rochester, New York, United States, 14642
Sponsors and Collaborators
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
Investigators
Study Chair: Daniel B. Ornt University of Rochester
  More Information

Publications:
Responsible Party: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier: NCT00004285     History of Changes
Other Study ID Numbers: 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 )
Study First Received: October 18, 1999
Last Updated: September 13, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data and samples are available at the NIDDK central repository
Supporting Materials: Study Protocol
Clinical Study Report (CSR)
Analytic Code
Time Frame: Available since 2009
URL: https://www.niddkrepository.org/studies/hemo/?query=hemo

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

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
end stage renal disease
rare disease
renal and genitourinary disorders

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency

ClinicalTrials.gov processed this record on September 19, 2017