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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

October 18, 1999
June 23, 2005
October 1992
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Complete list of historical versions of study NCT00004285 on ClinicalTrials.gov Archive Site
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Phase II Randomized Study of Standard Vs High Amount of Hemodialysis Using Low Vs High Flux Dialyzer Membranes for End Stage Renal Disease
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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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Primary Purpose: Treatment
End Stage Renal Disease
Procedure: Dialysis
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
900
December 2001
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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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00004285
199/11704, URSMD-HEMO-5813
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of Rochester
Study Chair: Daniel B. Ornt University of Rochester
Office of Rare Diseases (ORD)
July 2002

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP