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Kidney Sodium Functional Imaging

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05014178
Enrollment
200
Registered
2021-08-20
Start date
2021-09-16
Completion date
2026-02-28
Last updated
2025-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ADPKD, Chronic Kidney Disease, Nephrolithiasis

Keywords

cortico-medullary gradient

Brief summary

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.

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.

Interventions

DIAGNOSTIC_TESTSodium-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.

Sponsors

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.)

Design outcomes

Primary

MeasureTime frameDescription
Exploratory cortico-medullary gradient measurementThroughout study visit, on average 2 hoursExploratory 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

Secondary

MeasureTime frameDescription
Renal FunctionThroughout study visit, on average 2 hoursTo evaluate the relationship between sodium medullary to cortex ratio and renal function
Native and transplanted kidneyThroughout study visit, on average 2 hoursTo compare sodium medullary to cortex ratio between native kidney and transplanted kidney
Kidney biopsyThroughout study visit, on average 2 hoursTo compare sodium medullary to cortex ratio between transplanted kidney and kidney biopsy
Urinary osmolarityThroughout study visit, on average 2 hoursTo evaluate the relationship between sodium medullary to cortex ratio and urinary osmolarity
NephrolithiasisThroughout study visit, on average 2 hoursTo compare sodium medullary to cortex ratio between healthy control and patients who have nephrolithiasis
ADPKDThroughout study visit, on average 2 hoursTo evaluate the ability to measure sodium medullary to cortex ratio in autosomal dominant polycystic kidney disease
Clinical practiceThroughout study visit, on average 2 hoursTo determinate if measurement of sodium medullary to cortex ratio measurement is meaningful in clinical practice
Residual renal functionThroughout study visit, on average 2 hoursTo evaluate sodium medullary to cortex ratio in dialysis patients and renal residual function

Countries

Canada

Contacts

Primary ContactChristopher W McIntyre, MD
christopher.mcintyre@lhsc.on.ca5196858500
Backup ContactSandrine Lemoine, MD

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026