Kidney Sodium Functional Imaging

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorLondon Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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 population

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

Trial design

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

  • 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.

Treatment groups

200 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Adult CKD stage 1-5 participants1 intervention
Group B: Adult transplanted participants1 intervention
Group C: Adult dialysis participants1 intervention
Group D: Adult ADPKD1 intervention
Group E: Adults treated for nephrolithiasis1 intervention
Group F: Adult healthy controls including kidney donors1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Throughout study visit, on average 2 hours

Secondary outcomes

1

Urinary osmolarity

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

Time frame
Throughout study visit, on average 2 hours
2

Renal Function

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

Time frame
Throughout study visit, on average 2 hours
3

Native and transplanted kidney

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

Time frame
Throughout study visit, on average 2 hours
4

Kidney biopsy

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

Time frame
Throughout study visit, on average 2 hours

Other outcomes

Sponsors and contacts

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