Trial record 1 of 26 for:    Satellite Healthcare
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More Frequent Dialysis (>3 Treatments Per Week) (MFD)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2007 by Satellite Healthcare.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Satellite Healthcare
ClinicalTrials.gov Identifier:
NCT00575497
First received: December 14, 2007
Last updated: December 17, 2007
Last verified: December 2007

December 14, 2007
December 17, 2007
January 2005
Not Provided
Hospitalization days per year [ Time Frame: Ongoing ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00575497 on ClinicalTrials.gov Archive Site
  • Nutritional Status measured by Subjective Global Assessment [ Time Frame: Ongoing ] [ Designated as safety issue: No ]
  • Anemia, measured by erythropoetin dose [ Time Frame: Ongoing ] [ Designated as safety issue: No ]
  • Control of hypertension, as measured by number of antihypertensive tablets taken per day [ Time Frame: Ongoing ] [ Designated as safety issue: No ]
  • Control of hyperphosphatemia, as measured by number of phosphate binder tablets taken per day [ Time Frame: Ongoing ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
More Frequent Dialysis (>3 Treatments Per Week)
Study of Clinical Outcomes of More Frequent Hemodialysis

The study compares the benefits of short daily hemodialysis six days a week, nocturnal (night time) hemodialysis six days a week, every other day and every other night hemodialysis to traditional three days a week hemodialysis.The hypothesis is that increasing hemodialysis treatment time and/or frequency will improve outcomes.

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
  • End Stage Renal Disease
  • Chronic Kidney Disease
  • Procedure: More frequent hemodialysis
    Six Day per week short daily hemodialysis
  • Procedure: More frequent hemodialysis
    Six nights per week nocturnal hemodialysis
  • Procedure: More frequent hemodialysis
    Every other day short daily hemodialysis
  • Procedure: More frequent hemodialysis
    Every other night hemodialysis
  • Procedure: More frequent hemodialysis
    5 days per week short daily hemodialysis
  • Procedure: More frequent hemodialysis
    5 nights per week hemodialysis
  • Procedure: Conventional Hemodialysis
    3 days per week short daily hemodialysis
  • Experimental: A
    Six Day per week short daily hemodialysis
    Intervention: Procedure: More frequent hemodialysis
  • Experimental: B
    Six nights per week nocturnal hemodialysis
    Intervention: Procedure: More frequent hemodialysis
  • Experimental: C
    Every other day short daily hemodialysis
    Intervention: Procedure: More frequent hemodialysis
  • Experimental: D
    Every other night hemodialysis
    Intervention: Procedure: More frequent hemodialysis
  • Experimental: E
    5 days per week short daily hemodialysis
    Intervention: Procedure: More frequent hemodialysis
  • Experimental: F
    5 nights per week hemodialysis
    Intervention: Procedure: More frequent hemodialysis
  • Active Comparator: G
    Conventional three time per week short daily hemodialysis
    Intervention: Procedure: Conventional Hemodialysis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
300
January 2010
Not Provided

Inclusion Criteria:

  • Stable vascular access, i.e., lack of needling difficulties and stable flow rates. Accesses will include fistulae, grafts, catheters and ports.
  • 18 years of age.
  • History of compliance with a dialysis treatment schedule, or if a new patient, express a willingness to be compliant with a treatment schedule.
  • Plan to continue care and follow-up at the investigational site.
  • Able to sign the informed consent and other relevant documents.

Exclusion Criteria:

  • History of poor compliance with thrice (or twice) weekly dialysis schedules as manifested by more than three unexplained missed treatments in the past six (6) months.
  • Pregnancy.
  • Intravenous drug abuser.
  • Expects to receive a transplant or transfer to another facility within six months of entering the study.
Both
Not Provided
No
Contact: Brigitte Schiller-Moran, MD 650-404-3640 schillerb@satellitehealth.com
Contact: Sheila J Doss, RN, CCRA 650-404-3621 dosss@satellitehealth.com
United States
 
NCT00575497
SR002MFD
No
Brigitte Schiller-Moran MD, Satellite Healthcare, Inc.
Satellite Healthcare
Not Provided
Study Director: John Moran, MD Satellite Healthcare, Inc.
Principal Investigator: Brigittte Schiller-Moran, MD Satellite Healthcare, Inc.
Satellite Healthcare
December 2007

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