Chronic Kidney DiseaseNCT05014178
Kidney Sodium Functional Imaging
An observational study of Chronic Kidney Disease and Nephrolithiasis, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Kidney Disease, Nephrolithiasis, ADPKD
- What is being tested?
- Sodium-23 MRI
- How many people
- 200 participants
- Where
- 1 siteCanada
- Study dates
- 16 Sep 2021to 28 Feb 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: CKD stage 1-5 Transplanted patients Maintenance dialysis (hemo and PD) ADPKD patient Patients treated for nephrolithiasis Healthy controls, including kidney donors
Who may be able to join
- 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
Who cannot join
- 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.)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sandrine Lemoine, MD contact
Canada1 site, 1 recruiting
- Recruiting
Victoria Hospital, London Health Sciences Centre
London, Ontario, N6A 5W9
Christopher W McIntyre, MD, 519-685-8500 ext. 58502, Christopher.McIntyre@lhsc.on.ca
About this study
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.
Read the 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
- Being tested
- Sodium-23 MRI
- Keywords
- cortico-medullary gradient
- Medical subject headings
- Renal Insufficiency, Chronic, Nephrolithiasis, Polycystic Kidney, Autosomal Dominant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium-23 MRIDiagnostic test
Participants will lay in the MRI bed for approximately 60 minutes during scanning while the MRI technologist takes detailed pictures of their kidneys.
| Study group | Role | What they receive |
|---|---|---|
| Adult CKD stage 1-5 participants | * Age greater than or equal to 18 years
* Estimated GFR < 90 mL/min/1.73m² Receives: Diagnostic Test: Sodium-23 MRI | |
| Adult transplanted participants | • Age greater than or equal to 18 years Receives: Diagnostic Test: Sodium-23 MRI | |
| Adult dialysis participants | * Age greater than or equal to 18 years
* More than 3 months duration of therapy Receives: Diagnostic Test: Sodium-23 MRI | |
| Adult ADPKD | • Age greater than or equal to 18 years Receives: Diagnostic Test: Sodium-23 MRI | |
| Adults treated for nephrolithiasis | • Age greater than or equal to 18 years Receives: 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 Receives: Diagnostic Test: Sodium-23 MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
- 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
Measured: Throughout study visit, on average 2 hours
Secondary outcomes (8)
Urinary osmolarity
To evaluate the relationship between sodium medullary to cortex ratio and urinary osmolarity
Measured: Throughout study visit, on average 2 hours
Renal Function
To evaluate the relationship between sodium medullary to cortex ratio and renal function
Measured: Throughout study visit, on average 2 hours
Native and transplanted kidney
To compare sodium medullary to cortex ratio between native kidney and transplanted kidney
Measured: Throughout study visit, on average 2 hours
Kidney biopsy
To compare sodium medullary to cortex ratio between transplanted kidney and kidney biopsy
Measured: Throughout study visit, on average 2 hours
Residual renal function
To evaluate sodium medullary to cortex ratio in dialysis patients and renal residual function
Measured: Throughout study visit, on average 2 hours
Nephrolithiasis
To compare sodium medullary to cortex ratio between healthy control and patients who have nephrolithiasis
Measured: Throughout study visit, on average 2 hours
ADPKD
To evaluate the ability to measure sodium medullary to cortex ratio in autosomal dominant polycystic kidney disease
Measured: Throughout study visit, on average 2 hours
Clinical practice
To determinate if measurement of sodium medullary to cortex ratio measurement is meaningful in clinical practice
Measured: Throughout study visit, on average 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2021
- Study start16 Sep 2021
- Primary completion31 Dec 2025 (estimated)
- Study completion28 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chris McIntyre, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05014178
- Sponsor's protocol ID
- 118638
- Status last verified
- Feb 2025
- First submitted
- 14 Aug 2021
- Last updated
- 12 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38688870
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kidney Sodium Functional Imaging: Evaluation of Kidney Medullary Sodium Content Using 23Na MRI in Kidney Disease
- ClinicalTrials.gov ID
- NCT05014178
- Acronym / sponsor ID
- 118638
- Conditions
- Chronic Kidney Disease, Nephrolithiasis, ADPKD
- Keywords
- cortico-medullary gradient
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- 16 Sep 2021 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 20 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Adult CKD stage 1-5 participants | – | Diagnostic Test: Sodium-23 MRI* Age greater than or equal to 18 years * Estimated GFR < 90 mL/min/1.73m² |
| Adult transplanted participants | – | Diagnostic Test: Sodium-23 MRI• Age greater than or equal to 18 years |
| Adult dialysis participants | – | Diagnostic Test: Sodium-23 MRI* Age greater than or equal to 18 years * More than 3 months duration of therapy |
| Adult ADPKD | – | Diagnostic Test: Sodium-23 MRI• Age greater than or equal to 18 years |
| Adults treated for nephrolithiasis | – | Diagnostic Test: Sodium-23 MRI• Age greater than or equal to 18 years |
| Adult healthy controls including kidney donors | – | Diagnostic Test: Sodium-23 MRI* Age greater than or equal to 18 years * Lack of kidney disease, heart failure, liver cirrhosis and peripheral |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- CKD stage 1-5 Transplanted patients Maintenance dialysis (hemo and PD) ADPKD patient Patients treated for nephrolithiasis Healthy controls, including kidney donors
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Pregnant, breastfeeding or intending pregnancy
- Contraindication to MRI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sodium-23 MRIParticipants will lay in the MRI bed for approximately 60 minutes during scanning while the MRI technologist takes detailed pictures of their kidneys. | Diagnostic test | Adult ADPKD, Adult CKD stage 1-5 participants, Adult dialysis participants, Adult healthy controls including kidney donors, Adult transplanted participants, Adults treated for nephrolithiasis |
Primary outcome
Exploratory cortico-medullary gradient measurement
Time frame: 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
8 secondary outcomes
Urinary osmolarity
Time frame: Throughout study visit, on average 2 hours
Renal Function
Time frame: Throughout study visit, on average 2 hours
Native and transplanted kidney
Time frame: Throughout study visit, on average 2 hours
Kidney biopsy
Time frame: Throughout study visit, on average 2 hours
Residual renal function
Time frame: Throughout study visit, on average 2 hours
Nephrolithiasis
Time frame: Throughout study visit, on average 2 hours
ADPKD
Time frame: Throughout study visit, on average 2 hours
Clinical practice
Time frame: Throughout study visit, on average 2 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2025.
- Derived from this study: PubMed 38688870Lemoine 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.
- Individual participant dataSharing planned: No
Related trials for Chronic Kidney Disease
Not yet recruitingObservational study
Microbiota Changes Related to Outcomes in Kidney Transplantation
End-stage Renal Disease (ESRD), Kidney Transplantation
RecruitingObservational study
The KidneyCARE (Community Access to Research Equity) Study
Chronic Kidney Disease, Dialysis
RecruitingObservational study
Collection of Human Samples to Study Hairy Cell and Other Leukemias, and to Develop Recombinant Immunotoxins for Cancer Treatment
Hairy Cell Leukemia (HCL), Chronic Lymphocytic Leukemia (CLL)
Not yet recruiting
Effects of Minimally vs. Ultra-Processed Diets on Potassium (K) Handling in CKD
Chronic Kidney Disease
RecruitingObservational study
Prevalence of Gastric Motor Dysfunction and Upper GI Symptoms in Gastric Antral Vascular Ectasias
Gastric Antral Vascular Ectasia, Cirrhosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sandrine Lemoine, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Disease and Nephrolithiasis, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christopher W McIntyre, MD (5196858500 ext. 58502, christopher.mcintyre@lhsc.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exploratory cortico-medullary gradient measurement (time frame: Throughout study visit, on average 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05014178, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2025.