Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2025-12-24 @ 10:58 PM
NCT ID:
NCT02945969
Eligibility Criteria:
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT02945969
Study Brief:
Protocol Section:
NCT02945969