Kidney Sodium Functional Imaging

NCT05014178 | Recruiting

• 1 other identifier: 118638
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Disease; Nephrolithiasis; ADPKD

Keywords

cortico-medullary gradient

Outcome Measures

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

  Throughout study visit, on average 2 hours

Secondary Outcomes (8)

• Urinary osmolarity

  Throughout study visit, on average 2 hours

• Renal Function

  Throughout study visit, on average 2 hours

• Native and transplanted kidney

  Throughout study visit, on average 2 hours

• Kidney biopsy

  Throughout study visit, on average 2 hours

• Residual renal function

  Throughout study visit, on average 2 hours

Study Arms (6)

Adult CKD stage 1-5 participants

* Age greater than or equal to 18 years * Estimated GFR \< 90 mL/min/1.73m²

Diagnostic Test: Sodium-23 MRI

Adult transplanted participants

• Age greater than or equal to 18 years

Diagnostic Test: Sodium-23 MRI

Adult dialysis participants

* Age greater than or equal to 18 years * More than 3 months duration of therapy

Diagnostic Test: Sodium-23 MRI

Adult ADPKD

• Age greater than or equal to 18 years

Diagnostic Test: Sodium-23 MRI

Adults treated for nephrolithiasis

• Age greater than or equal to 18 years

Diagnostic Test: Sodium-23 MRI

Adult healthy controls including kidney donors

* Age greater than or equal to 18 years * Lack of kidney disease, heart failure, liver cirrhosis and peripheral

Diagnostic Test: Sodium-23 MRI

Interventions

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.

Adult ADPKD; Adult CKD stage 1-5 participants; Adult dialysis participants; Adult healthy controls including kidney donors; Adult transplanted participants; Adults treated for nephrolithiasis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

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

Study Sites (1)

Victoria Hospital, London Health Sciences Centre

London, Ontario, N6A 5W9, Canada

RECRUITING

Related Publications (1)

• Lemoine S, Akbari A, Brahm G, Dorie J, Tamasi T, Penny J, McIntyre CW. Redefining the concept of residual renal function with kidney sodium MRI: a pilot study. Nephrol Dial Transplant. 2024 Oct 30;39(11):1809-1816. doi: 10.1093/ndt/gfae070.

  PMID: 38688870 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Complete blood count, urea, electrolytes, calcium, phosphate, 25-hydroxyVitamin D, CRP, glucose, intact PTH, creatinine, cystatin C, and osmolality.

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Nephrolithiasis; Polycystic Kidney, Autosomal Dominant

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Urolithiasis; Polycystic Kidney Diseases; Kidney Diseases, Cystic; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Ciliopathies; Genetic Diseases, Inborn

Central Study Contacts

Christopher W McIntyre, MD

CONTACT

5196858500; christopher.mcintyre@lhsc.on.ca

Sandrine Lemoine, MD

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nephrologist

Study Record Dates

• First Submitted: August 14, 2021
• First Posted: August 20, 2021
• Study Start: September 16, 2021
• Primary Completion: December 31, 2025
• Study Completion: February 28, 2026
• Last Updated: February 12, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)