Clinical trial NCT00004285: Effect of Dialysis Dose and Membrane Flux in Maintenance Hemodialysis
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
Overall status: COMPLETED
Phase: NA
Conditions: End Stage Renal Disease
Keywords: end stage renal disease
rare disease
renal and genitourinary disorders
Lead sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Sponsor class: NIH
Collaborators: name: University of Rochester
name: The Cleveland Clinic
name: Tufts Medical Center
name: Vanderbilt University
name: Icahn School of Medicine at Mount Sinai
name: Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
name: Washington University School of Medicine
name: University of Illinois at Chicago
name: Main Line Health
name: Emory University
name: Duke University
name: University of Texas Southwestern Medical Center
name: Brigham and Women's Hospital
name: Wake Forest University Health Sciences
name: University of Utah
name: University of California, Davis
name: University of Alabama at Birmingham
First posted: 1999-10-19
Enrollment: 1846
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Death from any cause
timeFrame: 5 years
Secondary outcomes:
measure: First hospitalization for cardiac causes or death from any cause
timeFrame: 5 years
measure: First hospitalization for infection or death from any cause
timeFrame: 5 years
measure: First >15% decrease in albumin or death from any cause
timeFrame: 5 years
measure: All hospitalizations not related to vascular access
timeFrame: 5 years
measure: Death due to cardiac causes
timeFrame: 5 years
measure: First hospitalization or death due to cardiac causes
timeFrame: 5 years
measure: Death due to infection
timeFrame: 5 years
measure: First hospitalization or death due to infection
timeFrame: 5 years
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester School of Medicine
state: New York
Study officials:
affiliation: University of Rochester
name: Daniel B. Ornt
role: STUDY_CHAIR
References:
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.
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.