Renal Failure Chronic Requiring HemodialysisNCT01015313
Effects of Intensified Sodium Management in Hemodialysis Patients
A study testing intensive sodium management in people with Renal Failure Chronic Requiring Hemodialysis, run by Renal Research Institute at 3 sites in United States.
Trial summary
The primary aim of this study is to investigate whether intensive sodium management by dietary sodium restriction and by preventing positive sodium balance during dialysis can be successfully applied in chronic hemodialysis patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Failure Chronic Requiring Hemodialysis
- What is being tested?
- intensive sodium management
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 3 sitesUnited States
- Study dates
- Nov 2009to Feb 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ambulatory, clinically stable maintenance hemodialysis patients on a thrice weekly HD regimen.
- Willing and able to provide written, signed informed consent after the nature of the study has been explained.
- Willing and able to comply with all study procedures.
- Age ≥18 years.
Who cannot join
- Simultaneous participation in another clinical study except observational trials.
- Any psychological condition which could interfere with the patient's ability to comply with the study protocol.
- Pregnancy.
- Amputation of a limb.
- Pacemaker, implantable pump, artificial joint.
- Expectation that native kidney function will recover.
Show all 9Show fewer
- Unable to verbally communicate in English or Spanish.
- Scheduled for living donor kidney transplant, change to peritoneal dialysis, home HD or plans to relocate to another center within the next 14 months.
- Life expectancy < 15 months
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Irving Place Dialysis Center
New York, New York, 10003
Upper Manhattan Dilaysis Center
New York, New York, 10025
Yorkville Dialysis Center
New York, New York, 10128
About this study
Official title: A Multi-center, Randomized, Controlled and Prospective Pilot Study on the Effects of Intensified Sodium Management on Hospitalization in Chronic Hemodialysis Patients.
The primary aim of this study is to investigate whether intensive sodium management by dietary sodium restriction and by preventing positive sodium balance during dialysis can be successfully applied in chronic hemodialysis patients. Secondary aims are to test if sodium restriction has positive effects on the frequency of hospital admissions, blood pressure, fluid overload, quality of life and residual renal function.
- Being tested
- intensive sodium management
- Keywords
- sodium, hypertension, volume overload
- Medical subject headings
- Hypertension, Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intensive sodium managementOther
- dietary sodium restriction
- avoiding positive sodium balance during dialysis by: aligning dialysate sodium with plasma sodium, avoiding sodium profiling, and avoiding saline solutions to treat intradialytic symptoms
| Study group | Role | What they receive |
|---|---|---|
| intensive sodium management | Experimental | Not described Receives: Other: intensive sodium management |
| standard care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
feasibility of intensive sodium management
Measured: 12 months
Secondary outcomes (1)
hospitalization
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2009 (estimated)
- Study startNov 2009
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Renal Failure Chronic Requiring HemodialysisStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Renal Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter Kotanko, MD, Principal investigator, Renal Research InstituteNathan W Levin, MD, Study director, Renal Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01015313
- Sponsor's protocol ID
- 208-12 (formerly 173-09)
- Status last verified
- Sep 2015
- First submitted
- 17 Nov 2009
- Last updated
- 1 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
McMahon EJ, Campbell KL, Bauer JD, Mudge DW, Kelly JT. Altered dietary salt intake for people with chronic kidney disease. Cochrane Database Syst Rev. 2021 Jun 24;6(6):CD010070. doi: 10.1002/14651858.CD010070.pub3.
PubMed 34164803
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Controlled and Prospective Pilot Study on the Effects of Intensified Sodium Management on Hospitalization in Chronic Hemodialysis Patients.
- ClinicalTrials.gov ID
- NCT01015313
- Acronym / sponsor ID
- 208-12 (formerly 173-09)
- Keywords
- sodium, hypertension, volume overload
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Renal Research InstituteUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 18 Nov 2009 (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.
The primary aim of this study is to investigate whether intensive sodium management by dietary sodium restriction and by preventing positive sodium balance during dialysis can be successfully applied in chronic hemodialysis patients. Secondary aims are to test if sodium restriction has positive effects on the frequency of hospital admissions, blood pressure, fluid overload, quality of life and residual renal function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intensive sodium management | Experimental | Other: intensive sodium management |
| standard care | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Ambulatory, clinically stable maintenance hemodialysis patients on a thrice weekly HD regimen.
- Willing and able to provide written, signed informed consent after the nature of the study has been explained.
- Willing and able to comply with all study procedures.
- Age ≥18 years.
Key exclusion criteria (9 listed)
- Simultaneous participation in another clinical study except observational trials.
- Any psychological condition which could interfere with the patient's ability to comply with the study protocol.
- Pregnancy.
- Amputation of a limb.
- Pacemaker, implantable pump, artificial joint.
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 |
|---|---|---|
| intensive sodium management1. dietary sodium restriction 2. avoiding positive sodium balance during dialysis by: aligning dialysate sodium with plasma sodium, avoiding sodium profiling, and avoiding saline solutions to treat intradialytic symptoms | Other | intensive sodium management |
Primary outcome
feasibility of intensive sodium management
Time frame: 12 months
1 secondary outcome
hospitalization
Time frame: 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2015.
- Derived from this study: PubMed 34164803McMahon EJ, Campbell KL, Bauer JD, Mudge DW, Kelly JT. Altered dietary salt intake for people with chronic kidney disease. Cochrane Database Syst Rev. 2021 Jun 24;6(6):CD010070. doi: 10.1002/14651858.CD010070.pub3.
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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.
Peter Kotanko, MD principal investigator
Renal Research Institute
Nathan W Levin, MD study director
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 intensive sodium management in people with Renal Failure Chronic Requiring Hemodialysis, 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 9 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: withdrawn, as of the sponsor's last update on 1 Oct 2015. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
feasibility of intensive sodium management (time frame: 12 months). 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 NCT01015313, 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 1 Oct 2015.