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NCT Number: NCT05014178

Kidney Sodium Functional Imaging

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

Sodium-23 MRI

Diagnostic Test

Participants will lay in the MRI bed for approximately 60 minutes during scanning while the MRI technologist takes detailed pictures of their kidneys.

Primary outcomes

  1. Exploratory cortico-medullary gradient measurement

    Time frame: Throughout study visit, on average 2 hours

    Exploratory cortico-medullary gradient measurement in a large range of kidney disease by measuring sodium medullary to cortex ratio with23Na kidney MRI in:

    • 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 outcomes

  1. Urinary osmolarity

    Time frame: Throughout study visit, on average 2 hours

    To evaluate the relationship between sodium medullary to cortex ratio and urinary osmolarity

  2. Renal Function

    Time frame: Throughout study visit, on average 2 hours

    To evaluate the relationship between sodium medullary to cortex ratio and renal function

  3. Native and transplanted kidney

    Time frame: Throughout study visit, on average 2 hours

    To compare sodium medullary to cortex ratio between native kidney and transplanted kidney

  4. Kidney biopsy

    Time frame: Throughout study visit, on average 2 hours

    To compare sodium medullary to cortex ratio between transplanted kidney and kidney biopsy

  5. Residual renal function

    Time frame: Throughout study visit, on average 2 hours

    To evaluate sodium medullary to cortex ratio in dialysis patients and renal residual function

  6. Nephrolithiasis

    Time frame: Throughout study visit, on average 2 hours

    To compare sodium medullary to cortex ratio between healthy control and patients who have nephrolithiasis

  7. ADPKD

    Time frame: Throughout study visit, on average 2 hours

    To evaluate the ability to measure sodium medullary to cortex ratio in autosomal dominant polycystic kidney disease

  8. Clinical practice

    Time frame: Throughout study visit, on average 2 hours

    To determinate if measurement of sodium medullary to cortex ratio measurement is meaningful in clinical practice

Study contacts

Contact information is provided by the study sponsor or research team.

Christopher W McIntyre, MD

CONTACT

[email protected]

5196858500 ext. 58502

Sandrine Lemoine, MD

CONTACT

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2025
Study completion
2026
First posted
Aug 20, 2021
Registry last updated
Feb 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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