Chronic Kidney Disease Clinical Trial
Official title:
Kidney Sodium Functional Imaging: Evaluation of Kidney Medullary Sodium Content Using 23Na MRI in Kidney Disease
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.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | December 31, 2024 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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.) |
Country | Name | City | State |
---|---|---|---|
Canada | Victoria Hospital, London Health Sciences Centre | London | Ontario |
Lead Sponsor | Collaborator |
---|---|
Lawson Health Research Institute |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |
Throughout study visit, on average 2 hours | |
Secondary | Urinary osmolarity | To evaluate the relationship between sodium medullary to cortex ratio and urinary osmolarity | Throughout study visit, on average 2 hours | |
Secondary | Renal Function | To evaluate the relationship between sodium medullary to cortex ratio and renal function | Throughout study visit, on average 2 hours | |
Secondary | Native and transplanted kidney | To compare sodium medullary to cortex ratio between native kidney and transplanted kidney | Throughout study visit, on average 2 hours | |
Secondary | Kidney biopsy | To compare sodium medullary to cortex ratio between transplanted kidney and kidney biopsy | Throughout study visit, on average 2 hours | |
Secondary | Residual renal function | To evaluate sodium medullary to cortex ratio in dialysis patients and renal residual function | Throughout study visit, on average 2 hours | |
Secondary | Nephrolithiasis | To compare sodium medullary to cortex ratio between healthy control and patients who have nephrolithiasis | Throughout study visit, on average 2 hours | |
Secondary | ADPKD | To evaluate the ability to measure sodium medullary to cortex ratio in autosomal dominant polycystic kidney disease | Throughout study visit, on average 2 hours | |
Secondary | Clinical practice | To determinate if measurement of sodium medullary to cortex ratio measurement is meaningful in clinical practice | Throughout study visit, on average 2 hours |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
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