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Comparison of Daily Nocturnal Hemodialysis With Daily Hemodialysis

Primary Purpose

Kidney Failure, Chronic

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
hemodialysis
Sponsored by
National Center for Research Resources (NCRR)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney Failure, Chronic focused on measuring Renal Dialysis

Eligibility Criteria

21 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Adult patients with chronic renal failure requiring intermittent hemodialysis with a life expectancy of greater than 2 years

Sites / Locations

  • Washington University School of MedicineRecruiting

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
March 6, 2001
Last Updated
June 23, 2005
Sponsor
National Center for Research Resources (NCRR)
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1. Study Identification

Unique Protocol Identification Number
NCT00012441
Brief Title
Comparison of Daily Nocturnal Hemodialysis With Daily Hemodialysis
Official Title
Comparison of Daily Nocturnal Hemodialysis With Daily Hemodialysis
Study Type
Interventional

2. Study Status

Record Verification Date
December 2003
Overall Recruitment Status
Unknown status
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Center for Research Resources (NCRR)

4. Oversight

5. Study Description

Brief Summary
Hemodialysis remains associated with a high mortality (approximately 22% per year) and many complications despite improvements over the last twenty years. Several nephrologists have suggested that increasing the frequency and amount of dialysis will result in improved outcomes. In fact, various forms of daily dialysis have been performed in over 300 patients in the last 30 years with improvements in blood pressure, quality-of-life, bone disease, and other complications of renal failure. Whether this form of treatment can be expanded to the 220,000 Americans on hemodialysis is unknown. The primary outcome of this study is to determine the effectiveness of nocturnal dialysis in hemodialysis patients in St. Louis. If the pilot study is effective, then participation in a larger, multicenter trial is expected. The endpoints measured are use of antihypertensive medications, improvement in secondary hyperparathyroidism and use of phosphorus binders, quality-of-life measured by SF-36 surveys, and improvement in physical function as measured by maximal oxygen uptake.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Failure, Chronic
Keywords
Renal Dialysis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Allocation
Non-Randomized

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
hemodialysis

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Adult patients with chronic renal failure requiring intermittent hemodialysis with a life expectancy of greater than 2 years
Facility Information:
Facility Name
Washington University School of Medicine
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63108
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brent W. Miller, M.D.
Phone
314-286-0801
First Name & Middle Initial & Last Name & Degree
Brent W. Miller, M.D.

12. IPD Sharing Statement

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Comparison of Daily Nocturnal Hemodialysis With Daily Hemodialysis

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