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Sponsors and Collaborators: |
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) University of Rochester |
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Information provided by: | Office of Rare Diseases (ORD) |
ClinicalTrials.gov Identifier: | NCT00004285 |
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 | Phase |
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End Stage Renal Disease |
Procedure: Dialysis |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Efficacy Study |
Estimated Enrollment: | 900 |
Study Start Date: | October 1992 |
Estimated Study Completion Date: | December 2001 |
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.
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
--Prior/Concurrent Therapy--
--Patient Characteristics--
United States, New York | |
University of Rochester School of Medicine | |
Rochester, New York, United States, 14642 |
Study Chair: | Daniel B. Ornt | University of Rochester |
Study ID Numbers: | 199/11704, URSMD-HEMO-5813 |
Study First Received: | October 18, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00004285 |
Health Authority: | United States: Federal Government |
end stage renal disease rare disease renal and genitourinary disorders |
Renal Insufficiency Urologic Diseases Renal Insufficiency, Chronic Rare Diseases |
Kidney Failure, Chronic Kidney Diseases Kidney Failure |