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

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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.
Information provided by Office of Rare Diseases (ORD)

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

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

Official Title ^†

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.

Study Phase

Phase II

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Efficacy Study

Primary Outcome Measure ^†

Secondary Outcome Measure ^†

Condition ^†

End Stage Renal Disease

Intervention ^†

Procedure: Dialysis

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Completed

Enrollment ^†

900

Start Date ^†

October 1992

Completion Date

December 2001

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

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Administrative Information Fields

NCT ID ^†

NCT00004285

Organization ID

199/11704

Secondary IDs ^††

URSMD-HEMO-5813

Study Sponsor ^†

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

Collaborators ^††

University of Rochester

Investigators ^†

Study Chair:

Daniel B. Ornt

University of Rochester

Information Provided By

Office of Rare Diseases (ORD)

Verification Date

July 2002

First Received Date ^†

October 18, 1999

Last Updated Date

June 23, 2005

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.