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

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 II

Genetics Home Reference related topics:

Kidney Failure

MedlinePlus related topics:

Kidney Failure

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Efficacy Study

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

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

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

University of Rochester

Investigators


Study Chair:	Daniel B. Ornt	University of Rochester

More Information

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

Keywords provided by Office of Rare Diseases (ORD):

end stage renal disease

rare disease

renal and genitourinary disorders

Study placed in the following topic categories:

Renal Insufficiency

Pregnancy Complications

Urologic Diseases

Renal Insufficiency, Chronic

Rare Diseases

Kidney Failure, Chronic

Kidney Diseases

Kidney Failure

Additional relevant MeSH terms:

Female Urogenital Diseases and Pregnancy Complications

Male Urogenital Diseases

Female Urogenital Diseases

ClinicalTrials.gov processed this record on May 11, 2008

Sponsors and Collaborators:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) University of Rochester
Information provided by:	Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier:	NCT00004285