Clinical trial NCT05014178: Kidney Sodium Functional Imaging
Official title: Kidney Sodium Functional Imaging: Evaluation of Kidney Medullary Sodium Content Using 23Na MRI in Kidney Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Kidney Disease
Nephrolithiasis
ADPKD
Keywords: cortico-medullary gradient
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2021-08-20
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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

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.

Eligibility criteria: 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.)

Primary outcomes:
measure: Exploratory cortico-medullary gradient measurement
timeFrame: Throughout study visit, on average 2 hours
Secondary outcomes:
measure: Urinary osmolarity
timeFrame: Throughout study visit, on average 2 hours
measure: Renal Function
timeFrame: Throughout study visit, on average 2 hours
measure: Native and transplanted kidney
timeFrame: Throughout study visit, on average 2 hours
measure: Kidney biopsy
timeFrame: Throughout study visit, on average 2 hours
measure: Residual renal function
timeFrame: Throughout study visit, on average 2 hours
measure: Nephrolithiasis
timeFrame: Throughout study visit, on average 2 hours
measure: ADPKD
timeFrame: Throughout study visit, on average 2 hours
measure: Clinical practice
timeFrame: Throughout study visit, on average 2 hours
Other outcomes:
Locations:
city: London
country: Canada
facility: Victoria Hospital, London Health Sciences Centre
state: Ontario
Study officials:
References: