More Frequent Dialysis (>3 Treatments Per Week)
MFD
Study of Clinical Outcomes of More Frequent Hemodialysis
1 other identifier
interventional
46
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2005
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2005
CompletedFirst Submitted
Initial submission to the registry
December 14, 2007
CompletedFirst Posted
Study publicly available on registry
December 18, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 7, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
August 7, 2012
CompletedApril 19, 2019
April 1, 2019
7.6 years
December 14, 2007
April 17, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hospitalization days per year
Ongoing
Secondary Outcomes (4)
Nutritional Status measured by Subjective Global Assessment
Ongoing
Anemia, measured by erythropoetin dose
Ongoing
Control of hypertension, as measured by number of antihypertensive tablets taken per day
Ongoing
Control of hyperphosphatemia, as measured by number of phosphate binder tablets taken per day
Ongoing
Study Arms (7)
A
EXPERIMENTALSix Day per week short daily hemodialysis
B
EXPERIMENTALSix nights per week nocturnal hemodialysis
C
EXPERIMENTALEvery other day short daily hemodialysis
D
EXPERIMENTALEvery other night hemodialysis
E
EXPERIMENTAL5 days per week short daily hemodialysis
F
EXPERIMENTAL5 nights per week hemodialysis
G
ACTIVE COMPARATORConventional three time per week short daily hemodialysis
Interventions
Eligibility Criteria
You may qualify if:
- Stable vascular access, i.e., lack of needling difficulties and stable flow rates. Accesses will include fistulae, grafts, catheters and ports.
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Satellite Healthcare, Inc.
Mountain View, California, 64041, United States
WellBound, Inc.
Mountain View, California, 94041, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
John Moran, MD
Satellite Healthcare, Inc.
- PRINCIPAL INVESTIGATOR
Brigittte Schiller-Moran, MD
Satellite Healthcare, Inc.
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 14, 2007
First Posted
December 18, 2007
Study Start
January 1, 2005
Primary Completion
August 7, 2012
Study Completion
August 7, 2012
Last Updated
April 19, 2019
Record last verified: 2019-04