Kidney Failure, ChronicNCT00141622
Sodium-Endothelial Function-CKD Study
A study testing Slow sodium in people with Kidney Failure, Chronic, run by St George's, University of London at 1 site in United Kingdom.
Trial summary
Heart disease and stroke, known as cardiovascular disease, are major causes of death in people with chronic kidney disease. Abnormalities of a metabolic pathway called the "L-arginine-nitric oxide" pathway are thought to be particularly important in these people, and previous research in animals has suggested that… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Kidney Failure, Chronic
- What is being tested?
- Slow sodium
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2005to Oct 2006
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- CKD Stages 2 and 3 [= calculated creatinine clearance of 30 to 89 ml/min/1.73m2 by Cockcroft-Gault formula]
- 18 to 75 years old
Who cannot join
- >3 g/24 hours of proteinuria
- Uncontrolled hypertension (systolic BP >160 mmHg, diastolic BP >100 mmHg on/off anti-hypertensive medication)
- Diabetes mellitus
- Tobacco smoking
- Total fasting cholesterol >6 mmol/L
- Uncontrolled heart failure or active IHD
- Chronic liver failure
- Active malignancy
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Blood Pressure Unit, Department of Cardiac & Vascular Sciences, SGUL
London, SW17 0RE
About this study
Official title: Does Sodium Affect Endothelial Function in Individuals With Chronic Kidney Disease?
Heart disease and stroke, known as cardiovascular disease, are major causes of death in people with chronic kidney disease. Abnormalities of a metabolic pathway called the "L-arginine-nitric oxide" pathway are thought to be particularly important in these people, and previous research in animals has suggested that sodium (salt) affects part of this metabolic pathway. The purpose of our research is to study the effects of sodium intake on the "L-arginine-nitric oxide" pathway, and on blood vessel function, in patients with kidney disease.
Read the detailed description
Chronic kidney disease (CKD) is associated with abnormalities of endothelial function (EF) and nitric oxide (NO) synthesis, and it is proposed that the endogenous NO synthase inhibitor asymmetrical dimethylarginine (ADMA) plays a central role. In man ADMA is largely metabolized by dimethylarginine dimethylaminohydrolase (DDAH), with some renal excretion occurring. Sodium inhibits DDAH expression in experimental animals and, given that CKD is frequently characterized by sodium retention, it would be interesting to study the effects of sodium loading on DDAH activity/expression, ADMA levels and EF in CKD patients.
To answer these questions, we have designed a double-blind cross-over study employing Slow Sodium (150 mmol/day) and placebo for seven days in individuals with mild-to-moderate CKD. Changes in the ratio of urinary ADMA to dimethylamine (DMA, an ADMA metabolite) will be used as an marker of DDAH activity/expression. ADMA will be measured by ELISA, DMA by high performance liquid chromatography, and EF by venous occlusion plethysmography.
We propose to test the following hypothesis; that in subjects with mild-to-moderate CKD under conditions of high sodium intake, as compared to low-normal sodium intake:
(i) The ratio [ADMA]urine:[DMA]urine is increased (ii) [ADMA]plasma is increased (iii) Endothelium-dependent vasodilatation is reduced
- Conditions
- Kidney Failure, Chronic
- Being tested
- Slow sodium
- Keywords
- Endothelial dysfunction, ADMA, DDAH, Sodium
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Slow sodiumDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Under conditions of high (vs. low sodium intake) ...
(i) The ratio [ADMA]urine:[DMA]urine is increased
(ii) [ADMA]plasma is increased
(iii) Endothelium-dependent vasodilatation is reduced
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2005 (estimated)
- Study startApr 2005
- Study completionOct 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Failure, ChronicStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St George's, University of London
- Sponsor type
- University, hospital or other
- Collaborators
- British Heart Foundation, St. George's Hospital Charitable Foundation
- Investigators
- Timothy WR Doulton, BSc MRCP, Principal investigator, SGUL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00141622
- Sponsor's protocol ID
- LREC 04/Q0803/181
- Status last verified
- Aug 2005
- First submitted
- 31 Aug 2005
- Last updated
- 15 May 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Sodium Affect Endothelial Function in Individuals With Chronic Kidney Disease?
- ClinicalTrials.gov ID
- NCT00141622
- Acronym / sponsor ID
- LREC 04/Q0803/181
- Conditions
- Kidney Failure, Chronic
- Keywords
- Endothelial dysfunction, ADMA, DDAH, Sodium
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- St George's, University of LondonUniversity, hospital or other
- Collaborators
- British Heart Foundation, St. George's Hospital Charitable Foundation
- Study start
- Apr 2005
- Study completion
- Oct 2006
- First posted
- 1 Sep 2005 (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.
Heart disease and stroke, known as cardiovascular disease, are major causes of death in people with chronic kidney disease. Abnormalities of a metabolic pathway called the "L-arginine-nitric oxide" pathway are thought to be particularly important in these people, and previous research in animals has suggested that sodium (salt) affects part of this metabolic pathway. The purpose of our research is to study the effects of sodium intake on the "L-arginine-nitric oxide" pathway, and on blood vessel function, in patients with kidney disease.
Detailed description
Chronic kidney disease (CKD) is associated with abnormalities of endothelial function (EF) and nitric oxide (NO) synthesis, and it is proposed that the endogenous NO synthase inhibitor asymmetrical dimethylarginine (ADMA) plays a central role. In man ADMA is largely metabolized by dimethylarginine dimethylaminohydrolase (DDAH), with some renal excretion occurring. Sodium inhibits DDAH expression in experimental animals and, given that CKD is frequently characterized by sodium retention, it would be interesting to study the effects of sodium loading on DDAH activity/expression, ADMA levels and EF in CKD patients.
To answer these questions, we have designed a double-blind cross-over study employing Slow Sodium (150 mmol/day) and placebo for seven days in individuals with mild-to-moderate CKD. Changes in the ratio of urinary ADMA to dimethylamine (DMA, an ADMA metabolite) will be used as an marker of DDAH activity/expression. ADMA will be measured by ELISA, DMA by high performance liquid chromatography, and EF by venous occlusion plethysmography.
We propose to test the following hypothesis; that in subjects with mild-to-moderate CKD under conditions of high sodium intake, as compared to low-normal sodium intake:
(i) The ratio [ADMA]urine:[DMA]urine is increased (ii) [ADMA]plasma is increased (iii) Endothelium-dependent vasodilatation is reduced
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- CKD Stages 2 and 3 [= calculated creatinine clearance of 30 to 89 ml/min/1.73m2 by Cockcroft-Gault formula]
- 18 to 75 years old
Key exclusion criteria (8 listed)
- >3 g/24 hours of proteinuria
- Uncontrolled hypertension (systolic BP >160 mmHg, diastolic BP >100 mmHg on/off anti-hypertensive medication)
- Diabetes mellitus
- Tobacco smoking
- Total fasting cholesterol >6 mmol/L
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 |
|---|---|---|
| Slow sodium | Drug | – |
Primary outcome
Under conditions of high (vs. low sodium intake) ...
(i) The ratio [ADMA]urine:[DMA]urine is increased
(ii) [ADMA]plasma is increased
(iii) Endothelium-dependent vasodilatation is reduced
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2007.
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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.
Timothy WR Doulton, BSc MRCP principal investigator
SGUL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Slow sodium in people with Kidney Failure, Chronic, run by St George's, University of London at 1 site in United Kingdom.
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 2 inclusion and 8 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 15 May 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Under conditions of high (vs. low sodium intake) .... The study lists 4 primary outcomes in all. 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 15 May 2007.