Chronic Kidney DiseasesNCT02421497
MRI Technical Development and Applications in Kidney Disease
An observational study of Chronic Kidney Diseases and Kidney Transplantation, run by University of Minnesota at 1 site in United States.
Trial summary
Magnetic resonance imaging (MRI), as a non-invasive and non-contrast enhanced technique, has the potential to improve patient health care and management. The overall objective of proposed project is to: 1. develop, customize, and optimize anatomic and functional MRI methods, 2. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Kidney Diseases, Kidney Transplantation, Dialysis
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jun 2028to 30 Dec 2029
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study populations vary across specific aims: normal healthy or control volunteers for Specific Aim 1, CKD patients and renal transplant recipients for Specific Aim 2.
Who may be able to join
- 1. Healthy Volunteer
- English- speaking as primary language.
- Age 45 years and older
- Able to complete an approximately 90 minute cognitive testing battery.
- Able to sign the informed consent, or allow a caregiver, relative, surrogate, or witness to sign the informed consent if participant is unable to do so.
- GFR < 90 ml/min/1.73m2
- Able to sign the informed consent, or allow a caregiver, relative, surrogate, or witness to sign the informed consent if participant is unable to do so.
- Age 45 years and older
Who cannot join
- Ferromagnetic implants
- Any foreign metal objects in the body
- History of shrapnel or shot gun injury
- Cardiac pacemakers
- Defibrillator
- Neuronal stimulator
Show all 23Show fewer
- Magnetic aneurysm clip
- Large tattoos on the abdomen or the brain and neck
- Hip replacement
- Too large to fit in the magnet (body mass index >= 40, approx.)
- Severe claustrophobia
- Women with pregnancy
- For Specific Aim 2: Pilot Studies with Patients
- Studies for CKD
- Acute psychiatric illness that would impede cognitive testing
- Active chemical dependence, such as alcohol, narcotics or other drugs
- Legally blind or unable to complete cognitive tests due to visual loss or deafness
- Dialysis dependent or renal transplant recipient at time of screening or baseline
- Chronic obstructive pulmonary disease
- Severe CI unable to complete the Modified Mini-Mental State Examination [3MSE]
- Studies for Renal Transplantation
- Not on dialysis due to allograft failure
- Chronic obstructive pulmonary disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Center for Magnetic Resonance Research
Minneapolis, Minnesota, 55455
Xiufeng Li, Ph.D., 612-626-2001
Xiufeng Li, Ph.D.
About this study
Magnetic resonance imaging (MRI), as a non-invasive and non-contrast enhanced technique, has the potential to improve patient health care and management. The overall objective of proposed project is to:
- develop, customize, and optimize anatomic and functional MRI methods,
- explore the use of MRI methods to study CKD and evaluate post-transplant kidneys, and
- investigate the potential of MRI in the diagnosis, prognosis, and monitoring of the progression of renal dysfunction.
In addition to direct studies of the kidney, brain MRI studies will also be performed to identify the cerebrovascular and cognitive effects of chronic renal function deficiency and medical treatment (e.g. hemodialysis and immunosuppression). The brain and kidneys have similar vascular bed, and both are susceptible to vascular injury, which provides the pathological basis for the widely recognized association of reduced renal function with prevalent cerebrovascular diseases (CVDs) and cognitive impairment (CI). The MRI methods in the brain will be applied to explore the origins for widely observed CVDs and prevalent cognitive impairment (CI) in kidney disease patients.
Read the detailed description
Specific Aims
The overall objective is to develop and validate MRI methods for the evaluation and monitoring of renal status and associated cerebrovascular effects of renal dysfunction and treatment. The proposed project include two phases: 1) MRI technical development and validation with reproducibility studies; 2) clinical pilot studies with two patient populations (CKD patients and renal transplant recipients) to explore the potential of MRI in evaluating CKD, post-transplantation renal dysfunction and cerebrovascular pathophysiology associated with or induced by reduced kidney function and renal replacement treatment. The ultimate goal is to use MRI as a non-invasive and non-contrast enhanced tool to facilitate the diagnosis and prognosis of renal dysfunction and associated diseases, and to assess the efficacy of therapeutic interventions, and monitor disease progress across time.
Specific Aim 1: Imaging technical development and protocol optimization for renal and cerebral MRI.
The overall goal is to develop, customize and optimize new MRI methods to overcome challenges due to physiological motions and facilitate clinical research studies of renal and cerebral diseases, which will include but not are limited to the following aspects.
Sub-Aim 1.1: Develop imaging methods to improve MRI quality and efficiency for renal disease studies.
Sub-Aim 1.2: Optimize gas-challenge functional MRI protocols to study cerebral and renal vascular endothelial dysfunction.
Sub-Aim 1.3: Evaluate the reproducibility of cerebral and renal MRI methods.
Specific Aim 2: Perform pilot studies to evaluate the potential of MRI in CKD patients and renal transplant recipients.
Sub-Aim 2.1: Evaluate the correspondence of MRI measures with clinical metrics (i.e. eGFR) and routinely assessed cognitive functions from CKD and ESRD patients.
This will be accomplished by performing both cross-sectional and longitudinal studies, which will allow us to evaluate the diagnostic and prognostic potential of these non-invasive imaging methods. The investigators hypothesize that the measurements from cerebral and/or renal MRI can effectively reflect cerebral and/or renal (anatomic and physiological) changes induced by CKD or dialysis treatment.
Sub-Aim 2.2: Investigate the potential of MRI methods in the evaluation of post-transplant kidneys.
This will be accomplished by imaging transplant recipients in three distinct cohorts; those with good allograft function but coming in for routine protocol biopsy, with stable renal function, and with unstable renal function due to post-transplant complications. These patient populations will receive protocol biopsies (i.e. scheduled repeat biopsies) as standard of care; therefore pathologic results will be available for correlation with MRI measures. The investigators hypothesize that MRI methods can be a non-invasive surrogate marker of renal tissue properties and functional changes induced by renal post-transplant dysfunction (e.g. renal rejection) currently only obtained through biopsy.
- Medical subject headings
- Renal Insufficiency, Chronic, Cognition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Normal Healthy Volunteer | Not described | |
| Non-CKD Control | Not described | |
| Chronic Kidney Disease (CKD) | Not described | |
| Dialysis Patients | Not described | |
| Renal Transplant Recipients | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correspondence of MRI measures with clinical metrics (i.e. eGFR) and routinely assessed cognitive functions from CKD and ESRD patients.
MRI measures will be evaluated both globally and regionally (e.g. frontal lobe and the hippocampus of the brain, renal cortex and medulla in each and both kidneys). The correlations among MRI measurements, the degree of CKD disease (as evaluated by eGFR) and the severity of cognitive impairment will be assessed using both cross-sectional and longitudinal analyses. Non-parametric analysis approach will be used instead of parametric if appropriate.
Measured: up to three years
The potential of MRI methods in the evaluation of post-transplant kidneys.
For each region in kidneys (renal cortex and medulla), each MRI measurement from the cross-sectional studies of transplant recipients with stable renal functional will be correlated to the levels of transplant kidney function (e.g. eGFR). Imaging results from transplant recipients with unstable renal function will be compared between patients with and without diagnosed acute rejection, and before and after the acute rejection treatment for patients with positive response.
Note: For both outcomes, multi-parametric MRI measurements will be used in the evaluation, including but not limited to MRI relaxation times, blood flow and diffusion.
Measured: Up to three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2015 (estimated)
- Study start30 Jun 2028 (estimated)
- Primary completion30 Jun 2029 (estimated)
- Study completion30 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseasesStudies 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
- Prospective
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiufeng Li, Ph.D., Principal investigator, Univesity of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02421497
- Sponsor's protocol ID
- 1410M54981
- Status last verified
- Apr 2026
- First submitted
- 15 Apr 2015
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MRI Technical Development and Applications in Kidney Disease
- ClinicalTrials.gov ID
- NCT02421497
- Acronym / sponsor ID
- 1410M54981
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 30 Jun 2028 (estimated)
- Primary completion
- 30 Jun 2029 (estimated)
- Study completion
- 30 Dec 2029 (estimated)
- First posted
- 20 Apr 2015 (estimated)
- 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.
Magnetic resonance imaging (MRI), as a non-invasive and non-contrast enhanced technique, has the potential to improve patient health care and management. The overall objective of proposed project is to:
- develop, customize, and optimize anatomic and functional MRI methods,
- explore the use of MRI methods to study CKD and evaluate post-transplant kidneys, and
- investigate the potential of MRI in the diagnosis, prognosis, and monitoring of the progression of renal dysfunction.
In addition to direct studies of the kidney, brain MRI studies will also be performed to identify the cerebrovascular and cognitive effects of chronic renal function deficiency and medical treatment (e.g. hemodialysis and immunosuppression). The brain and kidneys have similar vascular bed, and both are susceptible to vascular injury, which provides the pathological basis for the widely recognized association of reduced renal function with prevalent cerebrovascular diseases (CVDs) and cognitive impairment (CI). The MRI methods in the brain will be applied to explore the origins for widely observed CVDs and prevalent cognitive impairment (CI) in kidney disease patients.
Detailed description
Specific Aims
The overall objective is to develop and validate MRI methods for the evaluation and monitoring of renal status and associated cerebrovascular effects of renal dysfunction and treatment. The proposed project include two phases: 1) MRI technical development and validation with reproducibility studies; 2) clinical pilot studies with two patient populations (CKD patients and renal transplant recipients) to explore the potential of MRI in evaluating CKD, post-transplantation renal dysfunction and cerebrovascular pathophysiology associated with or induced by reduced kidney function and renal replacement treatment. The ultimate goal is to use MRI as a non-invasive and non-contrast enhanced tool to facilitate the diagnosis and prognosis of renal dysfunction and associated diseases, and to assess the efficacy of therapeutic interventions, and monitor disease progress across time.
Specific Aim 1: Imaging technical development and protocol optimization for renal and cerebral MRI.
The overall goal is to develop, customize and optimize new MRI methods to overcome challenges due to physiological motions and facilitate clinical research studies of renal and cerebral diseases, which will include but not are limited to the following aspects.
Sub-Aim 1.1: Develop imaging methods to improve MRI quality and efficiency for renal disease studies.
Sub-Aim 1.2: Optimize gas-challenge functional MRI protocols to study cerebral and renal vascular endothelial dysfunction.
Sub-Aim 1.3: Evaluate the reproducibility of cerebral and renal MRI methods.
Specific Aim 2: Perform pilot studies to evaluate the potential of MRI in CKD patients and renal transplant recipients.
Sub-Aim 2.1: Evaluate the correspondence of MRI measures with clinical metrics (i.e. eGFR) and routinely assessed cognitive functions from CKD and ESRD patients.
This will be accomplished by performing both cross-sectional and longitudinal studies, which will allow us to evaluate the diagnostic and prognostic potential of these non-invasive imaging methods. The investigators hypothesize that the measurements from cerebral and/or renal MRI can effectively reflect cerebral and/or renal (anatomic and physiological) changes induced by CKD or dialysis treatment.
Sub-Aim 2.2: Investigate the potential of MRI methods in the evaluation of post-transplant kidneys.
This will be accomplished by imaging transplant recipients in three distinct cohorts; those with good allograft function but coming in for routine protocol biopsy, with stable renal function, and with unstable renal function due to post-transplant complications. These patient populations will receive protocol biopsies (i.e. scheduled repeat biopsies) as standard of care; therefore pathologic results will be available for correlation with MRI measures. The investigators hypothesize that MRI methods can be a non-invasive surrogate marker of renal tissue properties and functional changes induced by renal post-transplant dysfunction (e.g. renal rejection) currently only obtained through biopsy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Normal Healthy Volunteer | – | – |
| Non-CKD Control | – | – |
| Chronic Kidney Disease (CKD) | – | – |
| Dialysis Patients | – | – |
| Renal Transplant Recipients | – | – |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study populations vary across specific aims: normal healthy or control volunteers for Specific Aim 1, CKD patients and renal transplant recipients for Specific Aim 2.
Key inclusion criteria (8 listed)
- 1. Healthy Volunteer
- English- speaking as primary language.
- Age 45 years and older
- Able to complete an approximately 90 minute cognitive testing battery.
- Able to sign the informed consent, or allow a caregiver, relative, surrogate, or witness to sign the informed consent if participant is unable to do so.
Key exclusion criteria (23 listed)
- Ferromagnetic implants
- Any foreign metal objects in the body
- History of shrapnel or shot gun injury
- Cardiac pacemakers
- Defibrillator
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correspondence of MRI measures with clinical metrics (i.e. eGFR) and routinely assessed cognitive functions from CKD and ESRD patients.
Time frame: up to three years
MRI measures will be evaluated both globally and regionally (e.g. frontal lobe and the hippocampus of the brain, renal cortex and medulla in each and both kidneys). The correlations among MRI measurements, the degree of CKD disease (as evaluated by eGFR) and the severity of cognitive impairment will be assessed using both cross-sectional and longitudinal analyses. Non-parametric analysis approach will be used instead of parametric if appropriate.
The potential of MRI methods in the evaluation of post-transplant kidneys.
Time frame: Up to three years
For each region in kidneys (renal cortex and medulla), each MRI measurement from the cross-sectional studies of transplant recipients with stable renal functional will be correlated to the levels of transplant kidney function (e.g. eGFR). Imaging results from transplant recipients with unstable renal function will be compared between patients with and without diagnosed acute rejection, and before and after the acute rejection treatment for patients with positive response. Note: For both outcomes, multi-parametric MRI measurements will be used in the evaluation, including but not limited to MRI relaxation times, blood flow and diffusion.
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 13 Apr 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Chronic Kidney Diseases
Recruiting
Post Market Study for VasQ, an External Support Implant for Arteriovenous Fistula
End Stage Renal Disease
RecruitingObservational study
A Natural History Study of Metabolic Sizing in Health and Disease
Metabolic Disorders, Cancer
Not yet recruiting
Manual Acupuncture for Intradialytic Nausea and Vomiting in Patients Undergoing Hemodialysis
Intradialytic Nausea and Vomiting, Chronic Kidney Disease
Not yet recruitingObservational study
Unmasking Diabetes in Dialysis With Continuous Glucose Monitoring
End Stage Kidney Disease (ESKD), Hyperglycaemia
RecruitingPhase 2
Study to Assess the Effects of ALN-ANG3 in Adult Participants With Diabetic Kidney Disease
Diabetic Kidney Disease (DKD)
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.
Xiufeng Li, Ph.D. principal investigator
Univesity of Minnesota
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 Diseases and Kidney Transplantation, run by University of Minnesota at 1 site in United States.
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 8 inclusion and 23 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: opening soon, as of the sponsor's last update on 13 Apr 2026. 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 United States. 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 Xiufeng Li, Ph.D. (612-625-7872, lixx1607@umn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correspondence of MRI measures with clinical metrics (i.e. eGFR) and routinely assessed cognitive functions from CKD and ESRD patients. (time frame: up to three years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Apr 2026.