Effect of Dialysis Dose and Membrane Flux in Maintenance Hemodialysis

NCT00004285 | Completed DMC FDA Device

• 18 other identifiers: 199/11704U01DK046109U01DK046114U01DK046126U01DK046140U01DK046143U01DK049240U01DK049241U01DK049242U01DK049243U01DK049244U01DK049249U01DK049252U01DK049254U01DK049259U01DK049261U01DK049264U01DK049271
• Study Type: interventional
• Target: 1,846
• Locations: 1 country
• Sites: 1

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.

Conditions

End Stage Renal Disease

Keywords

end stage renal disease; rare disease; renal and genitourinary disorders

Outcome Measures

Primary Outcomes (1)

• Death from any cause

  5 years

Secondary Outcomes (8)

• 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

  5 years

• All hospitalizations not related to vascular access

  5 years

• Death due to cardiac causes

  5 years

Study Arms (4)

Standard dose, low flux hemodialysis

ACTIVE COMPARATOR

Device: Standard dose, low flux hemodialysis

Standard dose, high flux hemodialysis

EXPERIMENTAL

Device: Standard dose, high flux hemodialysis

High dose, low flux hemodialysis

EXPERIMENTAL

Device: High dose, low flux hemodialysis

High dose, high flux hemodialysis

EXPERIMENTAL

Device: High dose, high flux hemodialysis

Interventions

Standard dose, low flux hemodialysis DEVICE

Standard dose, low flux hemodialysis

Standard dose, high flux hemodialysis DEVICE

Standard dose, high flux hemodialysis

High dose, low flux hemodialysis DEVICE

High dose, low flux hemodialysis

High dose, high flux hemodialysis DEVICE

High dose, high flux hemodialysis

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): lead
• University of Rochester: collaborator
• The Cleveland Clinic: collaborator
• Tufts Medical Center: collaborator
• Vanderbilt University: collaborator
• Icahn School of Medicine at Mount Sinai: collaborator
• Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center: collaborator
• Washington University School of Medicine: collaborator
• University of Illinois at Chicago: collaborator
• Main Line Health: collaborator
• Emory University: collaborator
• Duke University: collaborator
• University of Texas Southwestern Medical Center: collaborator
• Brigham and Women's Hospital: collaborator
• Wake Forest University Health Sciences: collaborator
• University of Utah: collaborator
• University of California, Davis: collaborator
• University of Alabama at Birmingham: collaborator

Study Sites (1)

University of Rochester School of Medicine

Rochester, New York, 14642, United States

Location

Related Publications (2)

• 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.

  PMID: 11018567 BACKGROUND

• 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.

  PMID: 12490682 RESULT

MeSH Terms

Conditions

Kidney Failure, Chronic; Rare Diseases; Urogenital Diseases

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Daniel B. Ornt

  University of Rochester

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 1999
• First Posted: October 19, 1999
• Study Start: March 1, 1995
• Primary Completion: December 31, 2001
• Study Completion: December 31, 2001
• Last Updated: September 14, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR, ANALYTIC CODE
• Time Frame: Available since 2009

Locations

US (1)