End Stage Renal Failure on DialysisNCT01892839
Increasing the Removal of Protein-Bound Solutes During Extended Hours Hemodialysis
A study testing low dialysate flow, smaller dialyzer and high dialysate flow, larger dialyzer in people with End Stage Renal Failure on Dialysis, run by Palo Alto Veterans Institute for Research at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- End Stage Renal Failure on Dialysis
- What is being tested?
- low dialysate flow, smaller dialyzer and high dialysate flow, larger dialyzer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2013to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- stable on nocturnal in-center dialysis located close to Stanford University and VA Palo Alto
Who cannot join
- recent use of antibiotics
- gastrointestinal disease
Trial locations and contacts
2 sites in 1 country.
tim meyer, md contact
United States2 sites, 2 recruiting
- Recruiting
Satellite Redwood City
Redwood City, California, 94063
Tim Meyer, MD, 650-852-3314, twmeyer@stanford.edu
Orlando Camacho, MD, 650-852-3314, orlandoc@stanford.edu
- Recruiting
Stanford University
Stanford, California, 94301
Timothy Meyer, MD, 650-852-3314, twmeyer@stanford.edu
Orlando Camacho, MD, 650-852-3314, orlandoc@stanford.edu
About this study
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.
- Conditions
- End Stage Renal Failure on Dialysis
- Being tested
- low dialysate flow, smaller dialyzer, high dialysate flow, larger dialyzer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low dialysate flow, smaller dialyzerOther
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.
high dialysate flow, larger dialyzerOther
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.
| Study group | Role | What they receive |
|---|---|---|
| high dialysate flow, larger dialyzer | Experimental | high dialysate flow, larger dialyzer Receives: Other: high dialysate flow, larger dialyzer |
| low dialysate flow, smaller dialyzer | Active comparator | low dialysate flow, smaller dialyzer Receives: Other: low dialysate flow, smaller dialyzer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma levels of the chemical p-cresol sulfate
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2013 (estimated)
- Study startJul 2013
- Primary completionDec 2015 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal Failure on DialysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Palo Alto Veterans Institute for Research
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Timothy W Meyer, MD, Principal investigator, PAIRE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01892839
- Sponsor's protocol ID
- MEY0026APR
- Status last verified
- Jul 2015
- First submitted
- 27 Jun 2013
- Last updated
- 13 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing the Removal of Protein-Bound Solutes During Extended Hours Hemodialysis
- ClinicalTrials.gov ID
- NCT01892839
- Acronym / sponsor ID
- MEY0026APR
- Conditions
- End Stage Renal Failure on Dialysis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Palo Alto Veterans Institute for ResearchUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 4 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| high dialysate flow, larger dialyzer | Experimental | Other: high dialysate flow, larger dialyzerhigh dialysate flow, larger dialyzer |
| low dialysate flow, smaller dialyzer | Active comparator | Other: low dialysate flow, smaller dialyzerlow dialysate flow, smaller dialyzer |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- stable on nocturnal in-center dialysis located close to Stanford University and VA Palo Alto
Key exclusion criteria (2 listed)
- recent use of antibiotics
- gastrointestinal disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| low dialysate flow, smaller dialyzerThe subject will receive dialysis on the usual schedule and for the usual time but with a lower than usual dialysate flow and small dialyzer. | Other | low dialysate flow, smaller dialyzer |
| high dialysate flow, larger dialyzerThe subject will receive dialysis on the usual schedule and for the usual time but with a higher than usual dialysate flow and large dialyzer. | Other | high dialysate flow, larger dialyzer |
Primary outcome
Plasma levels of the chemical p-cresol sulfate
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2015.
Related trials for End Stage Renal Failure on Dialysis
Recruiting
Guiding Optimal Blood Pressure Management in Peritoneal Dialysis Pilot Trial
End Stage Kidney Disease (ESKD), Hypertension (HTN)
RecruitingPhase 4
Empagliflozin in Heart Failure With Reduced Ejection Fraction and End Stage Renal Disease
Heart Failure With Reduced Ejection Fraction, End Stage Renal Disease on Dialysis
Not yet recruiting
Effects of Horticultural Therapy on Acute Stress and Salivary Cortisol Levels in Hemodialysis Patients
End-Stage Renal Disease, Renal Dialysis
Recruiting
Laser Acupuncture for Fatigue in Hemodialysis Patients
ESRD (End Stage Renal Disease), Dialysis
RecruitingObservational study
Sensor-based Congestion ALert for Events in Peritoneal Dialysis (SCALE-PD)
Kidney Disease, Peritoneal Dialysis (PD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
tim meyer, md contact
Timothy W Meyer, MD principal investigator
PAIRE
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing low dialysate flow, smaller dialyzer and high dialysate flow, larger dialyzer in people with End Stage Renal Failure on Dialysis, run by Palo Alto Veterans Institute for Research at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact tim meyer, md (650-852-3314), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma levels of the chemical p-cresol sulfate (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2015; AzTrials last refreshed its copy on 7 Nov 2026.