Kidney Sodium Functional Imaging

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

Status: Enrolling

Conditions: Chronic Kidney Disease; ADPKD; Nephrolithiasis

Treatments: Diagnostic Test: Sodium-23 MRI

Study type: Observational

Funder types: Other

Identifiers

NCT05014178

118638

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.)

Trial design

200 participants in 6 patient groups

Adult CKD stage 1-5 participants

Description:

* Age greater than or equal to 18 years * Estimated GFR \< 90 mL/min/1.73m²

Treatment:

Diagnostic Test: Sodium-23 MRI

Adult transplanted participants

Description:

• Age greater than or equal to 18 years

Treatment:

Diagnostic Test: Sodium-23 MRI

Adult dialysis participants

Description:

* Age greater than or equal to 18 years * More than 3 months duration of therapy

Treatment:

Diagnostic Test: Sodium-23 MRI

Adult ADPKD

Description:

• Age greater than or equal to 18 years

Treatment:

Diagnostic Test: Sodium-23 MRI

Adults treated for nephrolithiasis

Description:

• Age greater than or equal to 18 years

Treatment:

Diagnostic Test: Sodium-23 MRI

Adult healthy controls including kidney donors

Description:

* Age greater than or equal to 18 years * Lack of kidney disease, heart failure, liver cirrhosis and peripheral

Treatment:

Diagnostic Test: Sodium-23 MRI