Sodium Lowering and Urinary Protein Reduction Trial

NCT02945969 | Completed Phase 3 DMC

• 2 other identifiers: 1P20GM109036-P11P20GM109036
• Study Type: interventional
• Target: 151
• Locations: 1 country
• Sites: 1

Brief 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 halt the progression of chronic kidney disease.

Conditions

Chronic Kidney Disease; Albuminuria

Keywords

dietary sodium; albuminuria; chronic kidney disease

Outcome Measures

Primary Outcomes (1)

• Net Change in Urinary Albumin-to-Creatinine Ratio (ACR)

  Assessed twice at baseline, once at week 12, and twice at week 24

Secondary Outcomes (4)

• Net Change in Urinary Albumin

  Assessed twice at baseline, once at week 12, and twice at week 24

• Estimated Glomerular Filtration Rate (eGFR)

  Assessed at baseline, week 12, and week 24

• Blood Pressure

  Assessed twice at baseline, once at week 12, and twice at week 24

• Number of Antihypertensive Medications

  Assessed at baseline, week 12, and week 24

Study Arms (2)

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.

Behavioral: Low Sodium Diet

Usual Diet

NO INTERVENTION

No dietary intervention.

Interventions

Low Sodium Diet BEHAVIORAL

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.

Low Sodium Diet

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Tulane University School of Public Health and Tropical Medicine: lead

Study Sites (1)

Tulane University

New Orleans, Louisiana, 70112, United States

Location

Related Publications (1)

• 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.

  PMID: 34164803 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Albuminuria

Interventions

Diet, Sodium-Restricted

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Proteinuria; Urination Disorders; Urological Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Katherine T Mills, PhD, MSPH

  Tulane University School of Public Health and Tropical Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 25, 2016
• First Posted: October 26, 2016
• Study Start: November 1, 2016
• Primary Completion: January 1, 2021
• Study Completion: January 1, 2021
• Last Updated: December 21, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)