Kidney Sodium Functional Imaging

Kidney Sodium Functional Imaging: Evaluation of Kidney Medullary Sodium Content Using 23Na MRI in Kidney Disease

The corticomedullary gradient is largely responsible for developing the gradients that are needed to concentrate urine (more solutes and less water). The ability of the kidneys to produce concentrated urine is a major determinant of the ability to survive the warm weather. When temperatures are high, we lose water through sweat, and so the kidneys retain water to maintain fluidity in the blood. The maintenance of a sodium (salt) gradient is required for urine concentration because increased medullary sodium concentration increases the reabsorption of water into the kidney, to be redistributed in the blood. The purpose of this study is to know if the corticomedullary gradient is altered in patients across a wide spectrum of kidney disease using sodium Magnetic Resonance Imaging (MRI), a machine that takes pictures and measures the salt content in the kidneys. 23Na kidney MRI, will provide functional MR of the kidney as a non-invasive tool to describe medullary function to improve management of chronic and kidney disease.

Study Overview

• Status: Recruiting
• Conditions: Nephrolithiasis; Chronic Kidney Disease; ADPKD
• Intervention / Treatment: Diagnostic test: Sodium-23 MRI

Detailed Description

This study is a pilot exploratory study (preliminary project to assess the use of a kidney sodium coil across a wide spectrum of kidney disease). Approximately 200 patients from the London Health Sciences Regional Renal Program will be recruited. This study involves two visits at Robarts Research Institute or St. Joseph's Hospital, London, Ontario depending on scanner availability, lasting approximately 2 hours.

At the first study visit participants will undergo a sodium MRI scan of your kidneys. Prior to the scan, participants will have their sitting blood pressure and heart rate measured three times consecutively using a standard automatic blood pressure monitor. In addition to this, participants will be asked to provide a spot urine sample and have blood work done. If participants have been treated for nephrolithiasis, they will be responsible for completing a 24-hour urine volume test sometime the week before the MRI scan.

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Sandrine LEMOINE, MD
• Study Contact Backup: Name: Christopher W McIntyre, MD; Phone Number: 58502 5196858500; Email: christopher.mcintyre@lhsc.on.ca

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6A 5W9
      • Recruiting
      • Victoria Hospital, London Health Sciences Centre
      • Contact: Christopher W McIntyre, MD; Phone Number: 58502 519-685-8500; Email: Christopher.McIntyre@lhsc.on.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

CKD stage 1-5 Transplanted patients Maintenance dialysis (hemo and PD) ADPKD patient Patients treated for nephrolithiasis Healthy controls, including kidney donors

Description

Inclusion Criteria:

• Age ≥ 18 years
• For healthy controls: lack of kidney disease, heart failure, liver cirrhosis and peripheral edema
• For CKD stage 1-5: Estimated GFR < 90 mL/min/1.73m²
• For patients on maintenance hemodialysis or peritoneal dialysis: more than 3 months duration of therapy

Exclusion Criteria:

• Pregnant, breastfeeding or intending pregnancy

• Contraindication to MRI

  • Inability to tolerate MRI due to patient size and/or known history of claustrophobia.
  • Mechanically implanted, electrically, or magnetically activated device or any metal in their body which cannot be removed, including but not limited to pacemakers, neurostimulators, biostimulators, implanted insulin pumps, aneurysm clips, bioprosthesis, artificial limb, metallic fragment or foreign body, tattoos, shunt, surgical staples (including clips or metallic sutures and/or ear implants.)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

6

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Adult CKD stage 1-5 participants; Age greater than or equal to 18 years; Estimated GFR < 90 mL/min/1.73m²	Diagnostic test: Sodium-23 MRI; Participants will lay in the MRI bed for approximately 60 minutes during scanning while the MRI technologist takes detailed pictures of their kidneys.
Adult transplanted participants; • Age greater than or equal to 18 years	Diagnostic test: Sodium-23 MRI; Participants will lay in the MRI bed for approximately 60 minutes during scanning while the MRI technologist takes detailed pictures of their kidneys.
Adult dialysis participants; Age greater than or equal to 18 years; More than 3 months duration of therapy	Diagnostic test: Sodium-23 MRI; Participants will lay in the MRI bed for approximately 60 minutes during scanning while the MRI technologist takes detailed pictures of their kidneys.
Adult ADPKD; • Age greater than or equal to 18 years	Diagnostic test: Sodium-23 MRI; Participants will lay in the MRI bed for approximately 60 minutes during scanning while the MRI technologist takes detailed pictures of their kidneys.
Adults treated for nephrolithiasis; • Age greater than or equal to 18 years	Diagnostic test: Sodium-23 MRI; Participants will lay in the MRI bed for approximately 60 minutes during scanning while the MRI technologist takes detailed pictures of their kidneys.
Adult healthy controls including kidney donors; Age greater than or equal to 18 years; Lack of kidney disease, heart failure, liver cirrhosis and peripheral	Diagnostic test: Sodium-23 MRI; Participants will lay in the MRI bed for approximately 60 minutes during scanning while the MRI technologist takes detailed pictures of their kidneys.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exploratory cortico-medullary gradient measurement	Exploratory cortico-medullary gradient measurement in a large range of kidney disease by measuring sodium medullary to cortex ratio with23Na kidney MRI in: 1) stage 1-5 CKD patients 2) transplanted patients 3) dialysis patients 4) ADPKD patients 5) nephrolithiasis patients (characteristically associated with salt loading) 6) healthy controls including kidney donors	Throughout study visit, on average 2 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Urinary osmolarity	To evaluate the relationship between sodium medullary to cortex ratio and urinary osmolarity	Throughout study visit, on average 2 hours
Renal Function	To evaluate the relationship between sodium medullary to cortex ratio and renal function	Throughout study visit, on average 2 hours
Native and transplanted kidney	To compare sodium medullary to cortex ratio between native kidney and transplanted kidney	Throughout study visit, on average 2 hours
Kidney biopsy	To compare sodium medullary to cortex ratio between transplanted kidney and kidney biopsy	Throughout study visit, on average 2 hours
Residual renal function	To evaluate sodium medullary to cortex ratio in dialysis patients and renal residual function	Throughout study visit, on average 2 hours
Nephrolithiasis	To compare sodium medullary to cortex ratio between healthy control and patients who have nephrolithiasis	Throughout study visit, on average 2 hours
ADPKD	To evaluate the ability to measure sodium medullary to cortex ratio in autosomal dominant polycystic kidney disease	Throughout study visit, on average 2 hours
Clinical practice	To determinate if measurement of sodium medullary to cortex ratio measurement is meaningful in clinical practice	Throughout study visit, on average 2 hours

Collaborators and Investigators

• Sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Study record dates

Study Major Dates

• Study Start (Actual): September 16, 2021
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): February 28, 2026

Study Registration Dates

• First Submitted: August 14, 2021
• First Submitted That Met QC Criteria: August 14, 2021
• First Posted (Actual): August 20, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 10, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: cortico-medullary gradient
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urolithiasis; Urinary Calculi; Chronic Disease; Disease Attributes; Renal Insufficiency; Kidney Calculi; Nephrolithiasis; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: 118638

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No