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	Treatment or Intervention	Phase
End Stage Renal Disease	Procedure: Dialysis	Phase II

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   -   80 Years,  Genders Eligible for Study:  Both

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

New York
      University of Rochester School of Medicine, Rochester,  New York,  14642,  United States

Study chairs or principal investigators

Daniel B. Ornt,  Study Chair,  University of Rochester   

Study ID Numbers:  199/11704; URSMD-HEMO-5813
Record last reviewed:  July 2002
Record first received:  October 18, 1999
ClinicalTrials.gov Identifier:  NCT00004285
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2004-10-29