End-stage Renal DiseaseNCT00825318
Comparison Study of Daily Ultrafiltration and Twice-weekly Hemodialysis
A study testing Ultrafiltration in people with End-stage Renal Disease, run by Renal Research Institute at 3 sites in United States.
Trial summary
In this study, the researchers want to find out how patients who have ultrafiltration (removal of excess fluid) 6 times a week and twice-weekly dialysis (removal of excess fluid and waste products) do in terms of their blood pressure and weight. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- End-stage Renal Disease
- What is being tested?
- Ultrafiltration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 3 sitesUnited States
- Study dates
- Jul 2009to Dec 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age greater than or equal to 18 years and less than or equal to 80 years
- Stable three treatments per week dialysis schedule for at least three months prior to beginning the study
- Residual renal clearance <1.5ml/min per 35L of urea volume
- Pre-dialysis serum sodium levels of greater than 136 mEq/L
Who cannot join
- Non-compliance with hemodialysis treatments--defined as missing more than 1 treatment over the 3 month period prior to the study
- Unable to verbally communicate in English or Spanish
- Current requirement for hemodialysis more than three times per week due to medical comorbidity (including fourth session for ultrafiltration)
- Currently on daily or nocturnal hemodialysis, or less than 3 months since discontinued such treatment
- Expected geographic unavailability at dialysis center during any phase of the trial
- Less than 3 months since the patient returned after acute rejection resulting in allograft failure
Show all 13Show fewer
- Currently in acute care or chronic care hospital
- Pregnancy
- Current involvement in any non-observational trial
- Unable or unwilling to follow the study protocol for any reason (including mental incompetence)
- Unable or unwilling to provide informed consent or sign IRB-approved consent form
- Pace maker, implantable pump, artificial joint
- Amputation of a limb
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Irving Place Dialysis Center
New York, New York, 10003
Upper Manhattan Dialysis Center
New York, New York, 10025
Yorkville Dialysis Center
New York, New York, 10128
About this study
Official title: Pilot Trial To Study Blood Pressure, Weight and Hydration State in Patients Undergoing A Treatment Regimen of Daily Ultrafiltration and Twice-weekly Hemodialysis As Compared to Conventional Three Times Per Week Hemodialysis
In this study, the researchers want to find out how patients who have ultrafiltration (removal of excess fluid) 6 times a week and twice-weekly dialysis (removal of excess fluid and waste products) do in terms of their blood pressure and weight. The researchers believe that maintaining patients at their estimated target weight throughout the week using daily ultrafiltration will reduce their blood pressure to levels shown in other similar studies. Such a reduction in blood pressure may reduce the incidence of cerebral vascular disease, peripheral vascular disease, coronary artery disease, and congestive heart failure. The researchers also believe that patients' quality of life will improve while they are undergoing daily ultrafiltration.
Studies show that more frequent dialysis treatments result in fewer symptoms for patients. The patients feel better and avoid the weight gains and symptoms that patients have on three times a week dialysis. In addition, their blood lab results are better controlled, requiring less medication.
- Conditions
- End-stage Renal Disease
- Being tested
- Ultrafiltration
- Keywords
- End-stage renal disease, Chronic kidney disease, Hemodialysis
- Medical subject headings
- Kidney Failure, Chronic, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrafiltrationProcedure or surgery
Frequency of ultrafiltration is increased from the conventional 3 times a week to 6 times a week.
| Study group | Role | What they receive |
|---|---|---|
| Daily ultrafiltration | Experimental | During the treatment phase of the study, the subject will undergo ultrafiltration 6 times a week and hemodialysis 2 times a week. Receives: Procedure: Ultrafiltration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Arterial Blood Pressure
Measured: Prestudy Phase (retrospective analysis, 3 months), Daily Ultrafiltration Phase (4 weeks), Return Phase (4 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2009 (estimated)
- Study startJul 2009
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for End-stage Renal DiseaseStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Renal Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Vizio Medical Devices
- Responsible party
- Sponsor
- Investigators
- Nathan W Levin, MD, Principal investigator, Renal Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00825318
- Sponsor's protocol ID
- 004-09
- Status last verified
- Apr 2014
- First submitted
- 16 Jan 2009
- Last updated
- 26 May 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Bytzer P. [Laxative abuse]. Ugeskr Laeger. 1986 Jun 2;148(23):1387-9. No abstract available. Danish.
PubMed 3727139
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Trial To Study Blood Pressure, Weight and Hydration State in Patients Undergoing A Treatment Regimen of Daily Ultrafiltration and Twice-weekly Hemodialysis As Compared to Conventional Three Times Per Week Hemodialysis
- ClinicalTrials.gov ID
- NCT00825318
- Acronym / sponsor ID
- 004-09
- Conditions
- End-stage Renal Disease
- Keywords
- End-stage renal disease, Chronic kidney disease, Hemodialysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Renal Research InstituteUniversity, hospital or other
- Collaborators
- Vizio Medical Devices
- Study start
- Jul 2009
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 21 Jan 2009 (estimated)
- Results
- Posted 26 May 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study, the researchers want to find out how patients who have ultrafiltration (removal of excess fluid) 6 times a week and twice-weekly dialysis (removal of excess fluid and waste products) do in terms of their blood pressure and weight. The researchers believe that maintaining patients at their estimated target weight throughout the week using daily ultrafiltration will reduce their blood pressure to levels shown in other similar studies. Such a reduction in blood pressure may reduce the incidence of cerebral vascular disease, peripheral vascular disease, coronary artery disease, and congestive heart failure. The researchers also believe that patients' quality of life will improve while they are undergoing daily ultrafiltration.
Studies show that more frequent dialysis treatments result in fewer symptoms for patients. The patients feel better and avoid the weight gains and symptoms that patients have on three times a week dialysis. In addition, their blood lab results are better controlled, requiring less medication.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Daily ultrafiltration | Experimental | Procedure: UltrafiltrationDuring the treatment phase of the study, the subject will undergo ultrafiltration 6 times a week and hemodialysis 2 times a week. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age greater than or equal to 18 years and less than or equal to 80 years
- Stable three treatments per week dialysis schedule for at least three months prior to beginning the study
- Residual renal clearance <1.5ml/min per 35L of urea volume
- Pre-dialysis serum sodium levels of greater than 136 mEq/L
Key exclusion criteria (13 listed)
- Non-compliance with hemodialysis treatments--defined as missing more than 1 treatment over the 3 month period prior to the study
- Unable to verbally communicate in English or Spanish
- Current requirement for hemodialysis more than three times per week due to medical comorbidity (including fourth session for ultrafiltration)
- Currently on daily or nocturnal hemodialysis, or less than 3 months since discontinued such treatment
- Expected geographic unavailability at dialysis center during any phase of the trial
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 |
|---|---|---|
| UltrafiltrationFrequency of ultrafiltration is increased from the conventional 3 times a week to 6 times a week. | Procedure or surgery | Daily ultrafiltration |
Primary outcome
Mean Arterial Blood Pressure
Time frame: Prestudy Phase (retrospective analysis, 3 months), Daily Ultrafiltration Phase (4 weeks), Return Phase (4 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 3727139Bytzer P. [Laxative abuse]. Ugeskr Laeger. 1986 Jun 2;148(23):1387-9. No abstract available. Danish.
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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.
Nathan W Levin, MD principal investigator
Renal Research Institute
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrafiltration in people with End-stage Renal Disease, run by Renal Research Institute at 3 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 4 inclusion and 13 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: finished, as of the sponsor's last update on 26 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Yes. Results are posted in the registry (first posted 26 May 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Arterial Blood Pressure (time frame: Prestudy Phase (retrospective analysis, 3 months), Daily Ultrafiltration Phase (4 weeks), Return Phase (4 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00825318, which also lists 1 linked publication.
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 26 May 2014.