Back to resultsEffect of Dialysis Dose and Membrane Flux in Maintenance Hemodialysis (HEMO)
Primary Purpose
End Stage Renal Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Standard dose, low flux hemodialysis
Standard dose, high flux hemodialysis
High dose, low flux hemodialysis
High dose, high flux hemodialysis
Sponsored by
About this trial
This is an interventional treatment trial for End Stage Renal Disease focused on measuring end stage renal disease, rare disease, renal and genitourinary disorders
Eligibility 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
Sites / Locations
- University of Rochester School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Experimental
Experimental
Experimental
Arm Label
Standard dose, low flux hemodialysis
Standard dose, high flux hemodialysis
High dose, low flux hemodialysis
High dose, high flux hemodialysis
Arm Description
Outcomes
Primary Outcome Measures
Death from any cause
Secondary Outcome Measures
First hospitalization for cardiac causes or death from any cause
First hospitalization for infection or death from any cause
First >15% decrease in albumin or death from any cause
All hospitalizations not related to vascular access
Death due to cardiac causes
First hospitalization or death due to cardiac causes
Death due to infection
First hospitalization or death due to infection
Full Information
NCT ID
NCT00004285
First Posted
October 18, 1999
Last Updated
September 13, 2017
Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborators
University of Rochester, The Cleveland Clinic, Tufts Medical Center, Vanderbilt University, Icahn School of Medicine at Mount Sinai, Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, 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
1. Study Identification
Unique Protocol Identification Number
NCT00004285
Brief Title
Effect of Dialysis Dose and Membrane Flux in Maintenance Hemodialysis
Acronym
HEMO
Official Title
Randomized Study of Standard vs High Amount of Hemodialysis Using Low vs High Flux Dialyzer Membranes for End Stage Renal Disease
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
March 1995 (Actual)
Primary Completion Date
December 31, 2001 (Actual)
Study Completion Date
December 31, 2001 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborators
University of Rochester, The Cleveland Clinic, Tufts Medical Center, Vanderbilt University, Icahn School of Medicine at Mount Sinai, Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, 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
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease
Keywords
end stage renal disease, rare disease, renal and genitourinary disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1846 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard dose, low flux hemodialysis
Arm Type
Active Comparator
Arm Title
Standard dose, high flux hemodialysis
Arm Type
Experimental
Arm Title
High dose, low flux hemodialysis
Arm Type
Experimental
Arm Title
High dose, high flux hemodialysis
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Standard dose, low flux hemodialysis
Intervention Type
Device
Intervention Name(s)
Standard dose, high flux hemodialysis
Intervention Type
Device
Intervention Name(s)
High dose, low flux hemodialysis
Intervention Type
Device
Intervention Name(s)
High dose, high flux hemodialysis
Primary Outcome Measure Information:
Title
Death from any cause
Time Frame
5 years
Secondary Outcome Measure Information:
Title
First hospitalization for cardiac causes or death from any cause
Time Frame
5 years
Title
First hospitalization for infection or death from any cause
Time Frame
5 years
Title
First >15% decrease in albumin or death from any cause
Time Frame
5 years
Title
All hospitalizations not related to vascular access
Time Frame
5 years
Title
Death due to cardiac causes
Time Frame
5 years
Title
First hospitalization or death due to cardiac causes
Time Frame
5 years
Title
Death due to infection
Time Frame
5 years
Title
First hospitalization or death due to infection
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel B. Ornt
Organizational Affiliation
University of Rochester
Official's Role
Study Chair
Facility Information:
Facility Name
University of Rochester School of Medicine
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Data and samples are available at the NIDDK central repository
IPD Sharing Time Frame
Available since 2009
IPD Sharing URL
https://www.niddkrepository.org/studies/hemo/?query=hemo
Citations:
PubMed Identifier
11018567
Citation
Greene T, Beck GJ, Gassman JJ, Gotch FA, Kusek JW, Levey AS, Levin NW, Schulman G, Eknoyan G. Design and statistical issues of the hemodialysis (HEMO) study. Control Clin Trials. 2000 Oct;21(5):502-25. doi: 10.1016/s0197-2456(00)00062-3.
Results Reference
background
PubMed Identifier
12490682
Citation
Eknoyan G, Beck GJ, Cheung AK, Daugirdas JT, Greene T, Kusek JW, Allon M, Bailey J, Delmez JA, Depner TA, Dwyer JT, Levey AS, Levin NW, Milford E, Ornt DB, Rocco MV, Schulman G, Schwab SJ, Teehan BP, Toto R; Hemodialysis (HEMO) Study Group. Effect of dialysis dose and membrane flux in maintenance hemodialysis. N Engl J Med. 2002 Dec 19;347(25):2010-9. doi: 10.1056/NEJMoa021583.
Results Reference
result
Learn more about this trial
Effect of Dialysis Dose and Membrane Flux in Maintenance Hemodialysis
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