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| ID | Type | Description | Link |
|---|---|---|---|
| U01DK046109 | U.S. NIH Grant/Contract | View source | |
| U01DK046114 | U.S. NIH Grant/Contract | View source | |
| U01DK046126 | U.S. NIH Grant/Contract | View source | |
| U01DK046140 | U.S. NIH Grant/Contract | View source | |
| U01DK046143 | U.S. NIH Grant/Contract | View source | |
| U01DK049240 | U.S. NIH Grant/Contract | View source | |
| U01DK049241 | U.S. NIH Grant/Contract | View source | |
| U01DK049242 | U.S. NIH Grant/Contract | View source | |
| U01DK049243 | U.S. NIH Grant/Contract | View source | |
| U01DK049244 | U.S. NIH Grant/Contract | View source | |
| U01DK049249 | U.S. NIH Grant/Contract | View source | |
| U01DK049252 | U.S. NIH Grant/Contract | View source | |
| U01DK049254 | U.S. NIH Grant/Contract | View source | |
| U01DK049259 | U.S. NIH Grant/Contract | View source | |
| U01DK049261 | U.S. NIH Grant/Contract | View source | |
| U01DK049264 | U.S. NIH Grant/Contract | View source | |
| U01DK049271 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of Rochester | OTHER |
| The Cleveland Clinic | OTHER |
| Tufts Medical Center | OTHER |
| Vanderbilt University |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard dose, low flux hemodialysis | Active Comparator |
| |
| Standard dose, high flux hemodialysis | Experimental |
| |
| High dose, low flux hemodialysis | Experimental |
| |
| High dose, high flux hemodialysis | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard dose, low flux hemodialysis | Device |
| ||
| Standard dose, high flux hemodialysis |
| Measure | Description | Time Frame |
|---|---|---|
| Death from any cause | 5 years |
| Measure | Description | 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 |
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PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
--Prior/Concurrent Therapy--
--Patient Characteristics--
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| Name | Affiliation | Role |
|---|---|---|
| Daniel B. Ornt | University of Rochester | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Rochester School of Medicine | Rochester | New York | 14642 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11018567 | Background | 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. | |
| 12490682 | Result | 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. |
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Data and samples are available at the NIDDK central repository
Available since 2009
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| OTHER |
| Icahn School of Medicine at Mount Sinai | OTHER |
| Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center | OTHER |
| Washington University School of Medicine | OTHER |
| University of Illinois at Chicago | OTHER |
| Main Line Health | OTHER |
| Emory University | OTHER |
| Duke University | OTHER |
| University of Texas Southwestern Medical Center | OTHER |
| Brigham and Women's Hospital | OTHER |
| Wake Forest University Health Sciences | OTHER |
| University of Utah | OTHER |
| University of California, Davis | OTHER |
| University of Alabama at Birmingham | OTHER |
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| Device |
|
| High dose, low flux hemodialysis | Device |
|
| High dose, high flux hemodialysis | Device |
|
| 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 |
| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| D035583 | Rare Diseases |
| D000091642 | Urogenital Diseases |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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