Kidney Sodium Functional Imaging

Sponsor
Lawson Health Research Institute (Other)
Overall Status
Recruiting
CT.gov ID
NCT05014178
Collaborator
(none)
200
1
14.5
13.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Sodium-23 MRI

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
200 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
Kidney Sodium Functional Imaging: Evaluation of Kidney Medullary Sodium Content Using 23Na MRI in Kidney Disease
Actual Study Start Date :
Sep 16, 2021
Anticipated Primary Completion Date :
Sep 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
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
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

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.

Adult dialysis participants

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

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.

Adult ADPKD

• Age greater than or equal to 18 years

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.

Adults treated for nephrolithiasis

• Age greater than or equal to 18 years

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.

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
Participants will lay in the MRI bed for approximately 60 minutes during scanning while the MRI technologist takes detailed pictures of their kidneys.

Outcome Measures

Primary Outcome Measures

  1. Exploratory cortico-medullary gradient measurement [Throughout study visit, on average 2 hours]

    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

Secondary Outcome Measures

  1. Urinary osmolarity [Throughout study visit, on average 2 hours]

    To evaluate the relationship between sodium medullary to cortex ratio and urinary osmolarity

  2. Renal Function [Throughout study visit, on average 2 hours]

    To evaluate the relationship between sodium medullary to cortex ratio and renal function

  3. Native and transplanted kidney [Throughout study visit, on average 2 hours]

    To compare sodium medullary to cortex ratio between native kidney and transplanted kidney

  4. Kidney biopsy [Throughout study visit, on average 2 hours]

    To compare sodium medullary to cortex ratio between transplanted kidney and kidney biopsy

  5. Residual renal function [Throughout study visit, on average 2 hours]

    To evaluate sodium medullary to cortex ratio in dialysis patients and renal residual function

  6. Nephrolithiasis [Throughout study visit, on average 2 hours]

    To compare sodium medullary to cortex ratio between healthy control and patients who have nephrolithiasis

  7. ADPKD [Throughout study visit, on average 2 hours]

    To evaluate the ability to measure sodium medullary to cortex ratio in autosomal dominant polycystic kidney disease

  8. Clinical practice [Throughout study visit, on average 2 hours]

    To determinate if measurement of sodium medullary to cortex ratio measurement is meaningful in clinical practice

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Victoria Hospital, London Health Sciences Centre London Ontario Canada N6A 5W9

Sponsors and Collaborators

  • Lawson Health Research Institute

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Chris McIntyre, Nephrologist, Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT05014178
Other Study ID Numbers:
  • 118638
First Posted:
Aug 20, 2021
Last Update Posted:
May 4, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Chris McIntyre, Nephrologist, Lawson Health Research Institute
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 4, 2022