Kidney Sodium Functional Imaging

Chronic Kidney Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05014178
• Other study ID #: 118638
• Status: Recruiting
• Start date: September 16, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: January 2024
• Source: Lawson Health Research Institute
• Contact: Christopher W McIntyre, MD
• Phone: 5196858500
• Email: christopher.mcintyre[@]lhsc.on.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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.)

Related Conditions & MeSH terms

• ADPKD
• Chronic Kidney Disease
• Kidney Calculi
• Kidney Diseases
• Nephrolithiasis
• Renal Insufficiency, Chronic

Intervention

Diagnostic Test:
• Sodium-23 MRI
Participants will lay in the MRI bed for approximately 60 minutes during scanning while the MRI technologist takes detailed pictures of their kidneys.

Locations

Country	Name	City	State
Canada	Victoria Hospital, London Health Sciences Centre	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Lawson Health Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

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