Kidney Sodium Functional Imaging

NCT ID: NCT05014178

Last Updated: 2025-02-12

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-09-16
• Study Completion Date: 2026-02-28

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.

Conditions

Chronic Kidney Disease; Nephrolithiasis; ADPKD

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Adult CKD stage 1-5 participants

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

Sodium-23 MRI

Intervention Type: 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 transplanted participants

• Age greater than or equal to 18 years

Sodium-23 MRI

Intervention Type: 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 dialysis participants

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

Sodium-23 MRI

Intervention Type: 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

• Age greater than or equal to 18 years

Sodium-23 MRI

Intervention Type: 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.

Adults treated for nephrolithiasis

• Age greater than or equal to 18 years

Sodium-23 MRI

Intervention Type: 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 healthy controls including kidney donors

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

Sodium-23 MRI

Intervention Type: 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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

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.)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Chris McIntyre

Nephrologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Victoria Hospital, London Health Sciences Centre

London, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Christopher W McIntyre, MD

Role: CONTACT

christopher.mcintyre@lhsc.on.ca

5196858500 ext. 58502

Sandrine Lemoine, MD

Role: CONTACT

Facility Contacts

Christopher W McIntyre, MD

Role: primary

Christopher.McIntyre@lhsc.on.ca

519-685-8500 ext. 58502

References

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.

Reference Type: DERIVED

PMID: 38688870 (View on PubMed)

Other Identifiers

118638

Identifier Type: -

Identifier Source: org_study_id