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
  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 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Study of Clinical Outcomes of More Frequent Hemodialysis

Resource links provided by NLM:


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
Experimental: A
Six Day per week short daily hemodialysis
Procedure: More frequent hemodialysis
Six Day per week short daily hemodialysis
Experimental: B
Six nights per week nocturnal hemodialysis
Procedure: More frequent hemodialysis
Six nights per week nocturnal hemodialysis
Experimental: C
Every other day short daily hemodialysis
Procedure: More frequent hemodialysis
Every other day short daily hemodialysis
Experimental: D
Every other night hemodialysis
Procedure: More frequent hemodialysis
Every other night hemodialysis
Experimental: E
5 days per week short daily hemodialysis
Procedure: More frequent hemodialysis
5 days per week short daily hemodialysis
Experimental: F
5 nights per week hemodialysis
Procedure: More frequent hemodialysis
5 nights per week hemodialysis
Active Comparator: G
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Keywords provided by Satellite Healthcare:
Hemodialysis
Adequacy
Frequency

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency

ClinicalTrials.gov processed this record on September 16, 2014