Effect of Dialysis Dose and Membrane Flux in Maintenance Hemodialysis

End Stage Renal Disease Clinical Trial

— HEMO  

Official title:

Randomized Study of Standard vs High Amount of Hemodialysis Using Low vs High Flux Dialyzer Membranes for End Stage Renal Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00004285
• Other study ID #: 199/11704
• Secondary ID: U01DK046109U01DK
• Status: Completed
• Phase: N/A
• First received: October 18, 1999
• Last updated: September 13, 2017
• Start date: March 1995
• Est. completion date: December 31, 2001

Study information

• Verified date: September 2017
• Source: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1846
• Est. completion date: December 31, 2001
• Est. primary completion date: December 31, 2001
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• End Stage Renal Disease
• Kidney Diseases
• Kidney Failure, Chronic
• Renal Insufficiency, Chronic

Intervention

Device:
• Standard dose, low flux hemodialysis

• Standard dose, high flux hemodialysis

• High dose, low flux hemodialysis

• High dose, high flux hemodialysis

Locations

Country	Name	City	State
United States	University of Rochester School of Medicine	Rochester	New York

Sponsors (18)

Lead Sponsor

Collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Brigham and Women's Hospital, Duke University, Emory University, Icahn School of Medicine at Mount Sinai, Los Angeles Biomedical Research Institute, Main Line Health, The Cleveland Clinic, Tufts Medical Center, University of Alabama at Birmingham, University of California, Davis, University of Illinois at Chicago, University of Rochester, University of Texas Southwestern Medical Center, University of Utah, Vanderbilt University, Wake Forest University Health Sciences, Washington University School of Medicine

Country where clinical trial is conducted

United States, 

References & Publications (2)

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 dial — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Death from any cause		5 years
Secondary	First hospitalization for cardiac causes or death from any cause		5 years
Secondary	First hospitalization for infection or death from any cause		5 years
Secondary	First >15% decrease in albumin or death from any cause		5 years
Secondary	All hospitalizations not related to vascular access		5 years
Secondary	Death due to cardiac causes		5 years
Secondary	First hospitalization or death due to cardiac causes		5 years
Secondary	Death due to infection		5 years
Secondary	First hospitalization or death due to infection		5 years