End Stage Renal Disease
Conditions
Keywords
end stage renal disease, rare disease, renal and genitourinary disorders
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.
Interventions
DEVICEStandard dose, low flux hemodialysis
DEVICEStandard dose, high flux hemodialysis
DEVICEHigh dose, low flux hemodialysis
DEVICEHigh dose, high flux hemodialysis
Sponsors
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
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Death from any cause | 5 years |
Secondary
| Measure | Time frame |
|---|---|
| First hospitalization for cardiac causes or death from any cause | 5 years |
| First hospitalization for infection or death from any cause | 5 years |
| First >15% decrease in albumin or death from any cause | 5 years |
| All hospitalizations not related to vascular access | 5 years |
| Death due to cardiac causes | 5 years |
| First hospitalization or death due to cardiac causes | 5 years |
| Death due to infection | 5 years |
| First hospitalization or death due to infection | 5 years |
Countries
United States
Outcome results
None listed