More Frequent Dialysis (>3 Treatments Per Week) - Full Text View

Sponsored by:	Satellite Healthcare
Information provided by:	Satellite Healthcare
ClinicalTrials.gov Identifier:	NCT00575497

Purpose

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.

Condition	Intervention	Phase
End Stage Renal Disease Chronic Kidney Disease	Procedure: More frequent hemodialysis Procedure: Conventional Hemodialysis	Phase IV

MedlinePlus related topics: Dialysis Kidney Failure

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study
Official Title:	Study of Clinical Outcomes of More Frequent Hemodialysis

Further study details as provided by Satellite Healthcare:

Primary Outcome Measures:

Hospitalization days per year [ Time Frame: Ongoing ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	300
Study Start Date:	January 2005
Estimated Study Completion Date:	January 2010

Arms	Assigned Interventions
A: Experimental Six Day per week short daily hemodialysis	Procedure: More frequent hemodialysis Six Day per week short daily hemodialysis
B: Experimental Six nights per week nocturnal hemodialysis	Procedure: More frequent hemodialysis Six nights per week nocturnal hemodialysis
C: Experimental Every other day short daily hemodialysis	Procedure: More frequent hemodialysis Every other day short daily hemodialysis
D: Experimental Every other night hemodialysis	Procedure: More frequent hemodialysis Every other night hemodialysis
E: Experimental 5 days per week short daily hemodialysis	Procedure: More frequent hemodialysis 5 days per week short daily hemodialysis
F: Experimental 5 nights per week hemodialysis	Procedure: More frequent hemodialysis 5 nights per week hemodialysis
G: Active Comparator Conventional three time per week short daily hemodialysis	Procedure: Conventional Hemodialysis 3 days per week short daily hemodialysis

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00575497

Contacts

Contact: Brigitte Schiller-Moran, MD	650-404-3640	schillerb@satellitehealth.com
Contact: Sheila J Doss, RN, CCRA	650-404-3621	dosss@satellitehealth.com

Locations

United States, California
Satellite Healthcare, Inc.	Recruiting
Mountain View, California, United States, 64041
Contact: Sheila J Doss, RN, CCRA 650-404-3621 dosss@satellitehealth.com
Principal Investigator: Brigitte Schiller-Moran, MD
WellBound, Inc.	Recruiting
Mountain View, California, United States, 94041
Contact: John Moran, MD 650-404-3620 moranj@satellitehealth.com
Contact: Sheila J Doss, RN, CCRA 650-404-3621 dosss@satellitehealth.com
Principal Investigator: Brigitte Schiller-Moran, MD

Sponsors and Collaborators

Satellite Healthcare

Investigators

Study Director:	John Moran, MD	Satellite Healthcare, Inc.
Principal Investigator:	Brigittte Schiller-Moran, MD	Satellite Healthcare, Inc.

More Information

No publications provided

Responsible Party:	Satellite Healthcare, Inc. ( Brigitte Schiller-Moran MD )
Study ID Numbers:	SR002MFD
Study First Received:	December 14, 2007
Last Updated:	December 17, 2007
ClinicalTrials.gov Identifier:	NCT00575497 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Satellite Healthcare:

Hemodialysis
Adequacy
Frequency

Study placed in the following topic categories:

Renal Insufficiency
Urologic Diseases
Renal Insufficiency, Chronic

Kidney Failure, Chronic
Kidney Diseases
Kidney Failure

Additional relevant MeSH terms:

Renal Insufficiency
Urologic Diseases
Renal Insufficiency, Chronic

Kidney Failure, Chronic
Kidney Diseases
Kidney Failure

ClinicalTrials.gov processed this record on May 07, 2009