Increasing the Removal of Protein-Bound Solutes During Extended Hours Hemodialysis
1 other identifier
interventional
24
1 country
2
Brief Summary
Hemodialysis keeps patients with renal failure alive but does not restore normal health. Retention of chemicals that bind to plasma proteins and are therefore poorly removed by dialysis may contribute to ill health in patients receiving conventional treatment. This proposal will test the effect of a new method designed to improve the removal of protein-bound solutes during dialysis. The effects on blood chemical levels of two different dialysis prescriptions will be tested in patients already undergoing nocturnal in-center hemodialysis three times weekly.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2013
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
First Submitted
Initial submission to the registry
June 27, 2013
CompletedStudy Start
First participant enrolled
July 1, 2013
CompletedFirst Posted
Study publicly available on registry
July 4, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedJuly 13, 2015
July 1, 2015
2.4 years
June 27, 2013
July 9, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Plasma levels of the chemical p-cresol sulfate
Participants will be followed for 2-3 weeks on different dialysis prescriptions and plasma chemical levels will be measured at the end of this period.
Study Arms (2)
high dialysate flow, larger dialyzer
EXPERIMENTALhigh dialysate flow, larger dialyzer
low dialysate flow, smaller dialyzer
ACTIVE COMPARATORlow dialysate flow, smaller dialyzer
Interventions
The subject will receive dialysis on the usual schedule and for the usual time but with a lower than usual dialysate flow and small dialyzer.
The subject will receive dialysis on the usual schedule and for the usual time but with a higher than usual dialysate flow and large dialyzer.
Eligibility Criteria
You may qualify if:
- stable on nocturnal in-center dialysis located close to Stanford University and VA Palo Alto
You may not qualify if:
- recent use of antibiotics
- gastrointestinal disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Satellite Redwood City
Redwood City, California, 94063, United States
Stanford University
Stanford, California, 94301, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Timothy W Meyer, MD
PAIRE
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 27, 2013
First Posted
July 4, 2013
Study Start
July 1, 2013
Primary Completion
December 1, 2015
Study Completion
December 1, 2016
Last Updated
July 13, 2015
Record last verified: 2015-07