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

This study has been completed.
Sponsor:
Collaborator:
University of Rochester
Information provided by:
Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier:
NCT00004285
First received: October 18, 1999
Last updated: June 23, 2005
Last verified: July 2002
  Purpose

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
End Stage Renal Disease
Procedure: Dialysis
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Office of Rare Diseases (ORD):

Estimated Enrollment: 900
Study Start Date: October 1992
Estimated Study Completion Date: December 2001
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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00004285

Locations
United States, New York
University of Rochester School of Medicine
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
Investigators
Study Chair: Daniel B. Ornt University of Rochester
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00004285     History of Changes
Other Study ID Numbers: 199/11704, URSMD-HEMO-5813
Study First Received: October 18, 1999
Last Updated: June 23, 2005
Health Authority: United States: Federal Government

Keywords provided by Office of Rare Diseases (ORD):
end stage renal disease
rare disease
renal and genitourinary disorders

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency

ClinicalTrials.gov processed this record on September 18, 2014