Assessing Renal Health with At Home Renal Functional Reserve Testing
Study on Kidney Health Using Home Tests
Michelle C. Starr, MD
Primary Investigator
Brief description of study
The purpose of this study is to establish and validate a method to quantify renal fitness in children and young adults at high risk for acute kidney injury (AKI) and chronic kidney disease (CKD) which we can use in children at high risk of CKD. We will do this by studying children and young adult patients with vesicoureteral reflux (VUR).
Detailed description of study
Aim 1. Determine if home renal functional reserve testing and in study clinic renal functional reserve can be successfully used to estimate glomerular reserve in healthy volunteers.
Aim 2. Determine if home renal functional reserve can be successfully performed in healthy children.
Aim 3. Determine if glomerular reserve values in children and young adults with VUR are different from healthy children and young adults and those with chronic kidney disease as well as establish the association of glomerular reserve and the risk of AKI or subclinical AKI in young adults with VUR.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Healthy, Chronic kidney disease, Congenital or acquired solitary functioning kidney, Vesicoureteral reflux, Riley
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Age: 6 years - 40 years
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Gender: All
Aim 1: Healthy Adult Volunteers (n = 4)
Inclusion Criteria:
• Age 18–40 years
• No history of kidney disease or structural urinary tract abnormalities
• Normal baseline kidney function (eGFR 90-120 mL/min/1.73 m²)
• Normotensive (blood pressure • Ability to comply with renal functional reserve (RFR) testing procedures
Exclusion Criteria:
• History of chronic kidney disease (CKD), acute kidney injury (AKI), diabetes mellitus, or hypertension
• Current use of medications affecting renal hemodynamics (e.g., ACE inhibitors, ARBs, NSAIDs, diuretics)
• Pregnancy
• Acute illness within 2 weeks prior to testing
• Known allergy or contraindication to study dietary protein load
• Nonconsumption of beef
Aim 2: Healthy Pediatric Volunteers (n = 4)
Inclusion Criteria:
• Age 6–17 years
• No known kidney disease or structural urinary tract abnormalities
• Normotensive for age, sex, and height percentile
• Parent/guardian consent and child assent as appropriate
Exclusion Criteria:
• History of CKD, AKI, vesicoureteral reflux (VUR), or recurrent urinary tract infections
• Use of medications affecting renal perfusion or filtration
• Acute illness within 2 weeks prior to testing
• Inability to comply with study procedures, non consumption of beef.
Aim 3: Children and Young Adults with CKD or Solitary Kidney
Cohort A: CKD Group (n = 5)
Inclusion Criteria:
• Age 6–21 years
• Chronic kidney disease with eGFR • Clinically stable kidney function for ≥3 months
Exclusion Criteria:
• Acute kidney injury within prior 3 months
• Current dialysis or kidney transplant
• Uncontrolled hypertension
• Acute illness within 2 weeks
• Nonconsumption of beef/inability to comply with testing procedure
• Current use of medications affecting renal hemodynamics (e.g., ACE inhibitors, ARBs, NSAIDs, diuretics)
Cohort B: Solitary Kidney Group (n = 5)
Inclusion Criteria:
• Age 6–21 years
• Congenital or acquired solitary functioning kidney
• Baseline eGFR ≥60 mL/min/1.73 m²
• Clinically stable renal function
Exclusion Criteria:
• Acute kidney injury within prior 3 months
• Kidney transplant recipient
• Uncontrolled hypertension
• Acute illness within 2 weeks
• Nonconsumption of beef/inability to comply with testing procedure
• Current use of medications affecting renal hemodynamics (e.g., ACE inhibitors, ARBs, NSAIDs, diuretics)
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Aim 4: Children with Vesicoureteral Reflux (VUR) (n = 10)
Inclusion Criteria:
• Age 6–21 years
• Diagnosis of vesicoureteral reflux confirmed by imaging
• History of at least one documented urinary tract infection (UTI)
• Baseline eGFR ≥60 mL/min/1.73 m²
Exclusion Criteria:
• Current acute UTI at time of enrollment
• Acute kidney injury within prior 3 months
• Kidney transplant recipient
• Uncontrolled hypertension
• Inability to complete follow-up assessments at 2 years
• Nonconsumption of beef/inability to comply with testing procedure
• Current use of medications affecting renal hemodynamics (e.g., ACE inhibitors, ARBs, NSAIDs, diuretics)
This study investigates kidney health in children and young adults who are at risk for acute kidney injury (AKI) and chronic kidney disease (CKD). The purpose of this study is to establish a method to measure kidney fitness, particularly in those with vesicoureteral reflux (VUR). VUR is a condition where urine flows backward from the bladder to the kidneys, which can lead to kidney damage.
Participants will undergo renal functional reserve testing, both at home and in a clinic setting. This involves measuring how well the kidneys can increase their function in response to certain conditions. The study will compare these measurements in healthy individuals and those with VUR or CKD to better understand kidney health.
- Who can participate: Healthy adults aged 18–40 with no kidney disease can participate. Children aged 6–17 with no kidney disease are also eligible. Additionally, individuals aged 6–21 with CKD, a solitary kidney, or vesicoureteral reflux can join. Participants must not have recent acute illnesses or be taking certain medications.
- Study details: Participants will perform renal functional reserve testing, which involves specific procedures to assess kidney function.
