Chronic Kidney DiseasePhase 3SUPERNCT02945969
Sodium Lowering and Urinary Protein Reduction Trial
A Phase 3 study testing Low Sodium Diet in people with Chronic Kidney Disease and Albuminuria, run by Tulane University School of Public Health and Tropical Medicine at 1 site in United States.
Trial summary
The proposed randomized controlled trial will test the effect of dietary sodium reduction on albuminuria in patients with proteinuric chronic kidney disease. Results from this study will clarify the role of dietary sodium reduction in management of patients with proteinuric chronic kidney disease and its potential to… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Chronic Kidney Disease, Albuminuria
- What is being tested?
- Low Sodium Diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 151 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2016to Jan 2021
- Phase
- Phase 3
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men or women at least 21 years of age: The lower age limit was chosen based on the National Institutes of Health (NIH) definition of adults for participation in research
- Any race or ethnicity: The investigators expect to recruit 50-60% African American and 40-50% non-African American (White, Hispanic, and Asian Americans), with the vast majority of the latter being non-Hispanic Whites.
- eGFR < 90 mL/min/1.73m2 but > 30 mL/min/1.73m2. The upper limit for eGFR was chosen to include participants with a clinically significant decrease in renal function. The investigators chose an upper eGFR limit slightly higher than the Kidney Disease Outcomes Quality Initiative (KDOQI) definition of moderately reduced glomerular filtration rate (GFR) to be more inclusive of patients with mild reduction in GFR but significant proteinuria. The lower eGFR limit was set to exclude patients with advanced CKD, where the potential effects of dietary sodium reduction on proteinuria may not be apparent or greatly alter CKD progression. The eGFR to define eligibility will be calculated using calibrated serum creatinine values and the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) estimating equation.
- Albumin-to-creatinine ratio > 30mg/g
Who cannot join
- Albuminuria ≥1.5 g/g or kidney structural change
- Prior kidney transplant based on self-report
- Immunosuppression or other immunotherapy within the past six months prior to enrollment based on patient self-report
- History of cancer other than non-melanoma skin cancer within two years prior to enrollment based on patient self-report
- History of polycystic kidney disease
- Currently receiving dialysis treatment
Show all 12Show fewer
- History of human immunodeficiency virus (HIV)
- Current pregnancy, breastfeeding or plans to become pregnant during the study
- Consumption of ≥14 alcoholic drinks/week or consumption of ≥6 drinks/occasion
- Current participation in another lifestyle intervention trial
- Current residence or planned residence make it difficult to meet trial requirements
- Other concerns regarding ability to meet trial requirements, at the discretion of the principal investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Dietary Sodium Reduction in Kidney Disease Patients With Albuminuria
The proposed randomized controlled trial will test the effect of dietary sodium reduction on albuminuria in patients with proteinuric chronic kidney disease. Results from this study will clarify the role of dietary sodium reduction in management of patients with proteinuric chronic kidney disease and its potential to halt the progression of chronic kidney disease.
Read the detailed description
Proteinuria is an early and sensitive marker of kidney damage and a risk factor for chronic kidney disease (CKD) progression, cardiovascular disease and all-cause mortality. Several cross-sectional epidemiological studies have reported an association between sodium intake and albuminuria (majority of proteinuria) that is independent of blood pressure (BP). In addition, a handful of small clinical trials have suggested a reduction in dietary sodium intake may decrease albuminuria in patients with CKD. The overall goal of this randomized controlled trial is to study the effect of dietary sodium reduction on albuminuria in CKD patients with albuminuria. A total of 150 participants with CKD and albuminuria will be recruited and randomly assigned to either a 24-week intensive behavioral modification program designed to reduce dietary sodium intake to 2,300 mg/day or to usual care in a 1:1 randomization ratio. The primary outcome will be the difference between the active intervention and control groups for change in urinary albumin-to-creatinine ratio from baseline to 24 weeks of follow-up. Urinary albumin-to-creatinine ratio will be assessed as the average of two 24-hour urine collections at each time point. Secondary outcomes will include estimated glomerular filtration rate (eGFR), BP, and number of antihypertensive medications. Urinary sodium excretion will be used to measure the success of the intervention. Racial differences in albuminuria changes due to reduction in dietary sodium intake will be analyzed. The intervention program will be modeled on best practices derived from the investigators prior experience in conducting sodium reduction behavioral interventions. The intervention program will address individual barriers to long-term sodium reduction and generate collective enthusiasm and motivation for adherence to the program. Study staff will receive training and direct support from a consultant with extensive experience in successful implementation of behavioral and dietary modification interventions. Results from this study will clarify the role of dietary sodium reduction in management of CKD patients with albuminuria and its potential to halt the progression of CKD, a global public health concern. The study will also explore the interaction of race/ethnicity with dietary sodium reduction on albuminuria in CKD patients.
- Conditions
- Chronic Kidney Disease, Albuminuria
- Being tested
- Low Sodium Diet
- Keywords
- dietary sodium, albuminuria, chronic kidney disease
- Medical subject headings
- Renal Insufficiency, Chronic, Albuminuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Sodium DietBehavioural
Once randomized to the Intervention program, study participants will be grouped into intervention cohorts of approximately 10 participants per group to facilitate group counseling sessions. Both the intensive intervention phase and the maintenance phase will include individual and group behavioral modification counseling designed to facilitate a reduction in dietary sodium intake. Success of the intervention will be assessed by comparing the urine sodium measurements from 24-hour urine collections performed at screening, 12 weeks and 24 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Low Sodium Diet | Experimental | Behavioral modification to decrease dietary sodium intake to ≤2,300 mg/day for 24 weeks. The intervention program consists of two phases. An initial 12-week intensive phase will include weekly individual and group sessions. This will be followed by a 12-week maintenance phase that includes telephone counseling sessions every 2 weeks. Receives: Behavioral: Low Sodium Diet |
| Usual Diet | No intervention | No dietary intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Net Change in Urinary Albumin-to-Creatinine Ratio (ACR)
Measured: Assessed twice at baseline, once at week 12, and twice at week 24
Secondary outcomes (4)
Net Change in Urinary Albumin
Measured: Assessed twice at baseline, once at week 12, and twice at week 24
Estimated Glomerular Filtration Rate (eGFR)
Measured: Assessed at baseline, week 12, and week 24
Blood Pressure
Measured: Assessed twice at baseline, once at week 12, and twice at week 24
Number of Antihypertensive Medications
Measured: Assessed at baseline, week 12, and week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2016 (estimated)
- Study startNov 2016
- Primary completionJan 2021
- Study completionJan 2021
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 Chronic Kidney 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tulane University School of Public Health and Tropical Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katherine T Mills, Tulane University School of Public Health and Tropical Medicine
- Investigators
- Katherine T Mills, PhD, MSPH, Principal investigator, Tulane University School of Public Health and Tropical Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02945969
- Sponsor's protocol ID
- 1P20GM109036-P1
- Other IDs
- 1P20GM109036
- Acronym
- SUPER
- Status last verified
- Dec 2022
- First submitted
- 25 Oct 2016
- Last updated
- 21 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- 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 21 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dietary Sodium Reduction in Kidney Disease Patients With Albuminuria
- ClinicalTrials.gov ID
- NCT02945969
- Acronym / sponsor ID
- SUPER / 1P20GM109036-P1
- Conditions
- Chronic Kidney Disease, Albuminuria
- Keywords
- dietary sodium, albuminuria, chronic kidney disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- Tulane University School of Public Health and Tropical MedicineUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Jan 2021 (actual)
- Study completion
- Jan 2021 (actual)
- First posted
- 26 Oct 2016 (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 proposed randomized controlled trial will test the effect of dietary sodium reduction on albuminuria in patients with proteinuric chronic kidney disease. Results from this study will clarify the role of dietary sodium reduction in management of patients with proteinuric chronic kidney disease and its potential to halt the progression of chronic kidney disease.
Detailed description
Proteinuria is an early and sensitive marker of kidney damage and a risk factor for chronic kidney disease (CKD) progression, cardiovascular disease and all-cause mortality. Several cross-sectional epidemiological studies have reported an association between sodium intake and albuminuria (majority of proteinuria) that is independent of blood pressure (BP). In addition, a handful of small clinical trials have suggested a reduction in dietary sodium intake may decrease albuminuria in patients with CKD. The overall goal of this randomized controlled trial is to study the effect of dietary sodium reduction on albuminuria in CKD patients with albuminuria. A total of 150 participants with CKD and albuminuria will be recruited and randomly assigned to either a 24-week intensive behavioral modification program designed to reduce dietary sodium intake to 2,300 mg/day or to usual care in a 1:1 randomization ratio. The primary outcome will be the difference between the active intervention and control groups for change in urinary albumin-to-creatinine ratio from baseline to 24 weeks of follow-up. Urinary albumin-to-creatinine ratio will be assessed as the average of two 24-hour urine collections at each time point. Secondary outcomes will include estimated glomerular filtration rate (eGFR), BP, and number of antihypertensive medications. Urinary sodium excretion will be used to measure the success of the intervention. Racial differences in albuminuria changes due to reduction in dietary sodium intake will be analyzed. The intervention program will be modeled on best practices derived from the investigators prior experience in conducting sodium reduction behavioral interventions. The intervention program will address individual barriers to long-term sodium reduction and generate collective enthusiasm and motivation for adherence to the program. Study staff will receive training and direct support from a consultant with extensive experience in successful implementation of behavioral and dietary modification interventions. Results from this study will clarify the role of dietary sodium reduction in management of CKD patients with albuminuria and its potential to halt the progression of CKD, a global public health concern. The study will also explore the interaction of race/ethnicity with dietary sodium reduction on albuminuria in CKD patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low Sodium Diet | Experimental | Behavioral: Low Sodium DietBehavioral modification to decrease dietary sodium intake to ≤2,300 mg/day for 24 weeks. The intervention program consists of two phases. An initial 12-week intensive phase will include weekly individual and group sessions. This will be followed by a 12-week maintenance phase that includes telephone counseling sessions every 2 weeks. |
| Usual Diet | No intervention | –No dietary intervention. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men or women at least 21 years of age: The lower age limit was chosen based on the National Institutes of Health (NIH) definition of adults for participation in research
- Any race or ethnicity: The investigators expect to recruit 50-60% African American and 40-50% non-African American (White, Hispanic, and Asian Americans), with the vast majority of the latter being non-Hispanic Whites.
- eGFR < 90 mL/min/1.73m2 but > 30 mL/min/1.73m2. The upper limit for eGFR was chosen to include participants with a clinically significant decrease in renal function. The investigators chose an upper eGFR limit slightly higher than the Kidney Disease Outcomes Quality Initiative (KDOQI) definition of moderately reduced glomerular filtration rate (GFR) to be more inclusive of patients with mild reduction in GFR but significant proteinuria. The lower eGFR limit was set to exclude patients with advanced CKD, where the potential effects of dietary sodium reduction on proteinuria may not be apparent or greatly alter CKD progression. The eGFR to define eligibility will be calculated using calibrated serum creatinine values and the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) estimating equation.
- Albumin-to-creatinine ratio > 30mg/g
Key exclusion criteria (12 listed)
- Albuminuria ≥1.5 g/g or kidney structural change
- Prior kidney transplant based on self-report
- Immunosuppression or other immunotherapy within the past six months prior to enrollment based on patient self-report
- History of cancer other than non-melanoma skin cancer within two years prior to enrollment based on patient self-report
- History of polycystic kidney 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 Sodium DietOnce randomized to the Intervention program, study participants will be grouped into intervention cohorts of approximately 10 participants per group to facilitate group counseling sessions. Both the intensive intervention phase and the maintenance phase will include individual and group behavioral modification counseling designed to facilitate a reduction in dietary sodium intake. Success of the intervention will be assessed by comparing the urine sodium measurements from 24-hour urine collections performed at screening, 12 weeks and 24 weeks. | Behavioural | Low Sodium Diet |
Primary outcome
Net Change in Urinary Albumin-to-Creatinine Ratio (ACR)
Time frame: Assessed twice at baseline, once at week 12, and twice at week 24
4 secondary outcomes
Net Change in Urinary Albumin
Time frame: Assessed twice at baseline, once at week 12, and twice at week 24
Estimated Glomerular Filtration Rate (eGFR)
Time frame: Assessed at baseline, week 12, and week 24
Blood Pressure
Time frame: Assessed twice at baseline, once at week 12, and twice at week 24
Number of Antihypertensive Medications
Time frame: Assessed at baseline, week 12, and week 24
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 21 Dec 2022.
- 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.
- Individual participant dataSharing planned: No
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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.
Katherine T Mills, PhD, MSPH principal investigator
Tulane University School of Public Health and Tropical Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Low Sodium Diet in people with Chronic Kidney Disease and Albuminuria, run by Tulane University School of Public Health and Tropical Medicine at 1 site 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 12 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 21 Dec 2022. 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 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Net Change in Urinary Albumin-to-Creatinine Ratio (ACR) (time frame: Assessed twice at baseline, once at week 12, and twice at week 24). 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 NCT02945969, 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 21 Dec 2022.