Chronic Kidney DiseaseNCT02832505
Applications of MRI in Kidney Disease
An observational study of Chronic Kidney Disease and End-stage Kidney Disease, run by University of Minnesota at 1 site in United States.
Trial summary
This study has two major purposes: 1. To test developed multiple anatomic and functional MRI methods; 2. To evaluate the potentials of these MRI methods in the diagnosis, prognosis, and monitoring of the progression of renal dysfunction. Read more about this study
- Who is it for?
- Ages 45 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Kidney Disease, End-stage Kidney Disease
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Oct 2025to 30 Aug 2028
- Phase
- Observational
- Are there results?
- None posted in the registry
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 45 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population will include three main cohorts of patients: 20 ESRD patients with their transition to dialysis treatment, 20 CKD controls and 20 non-CKD controls. Based on the investigators previous experience, about 20% of recruited subjects may not be able to finish the proposed studies. Therefore, a conservative estimate of the total number of subjects to be recruited is 72.
Who may be able to join
- English-speaking as primary language
- Able to complete an approximately 75 to 90 minute cognitive and/or physical tests
- Capable to consent to studies
Who cannot join
- 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
- Renal transplant recipient at time of screening or baseline
- Severe CI unable to complete the Modified Mini-Mental State Examination [3MSE]
- Chronic and acute pulmonary disease
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota Medical Center
Minneapolis, Minnesota, 55455
About this study
This study has two major purposes:
- To test developed multiple anatomic and functional MRI methods;
- To evaluate the potentials of these MRI methods in the diagnosis, prognosis, and monitoring of the progression of renal dysfunction.
These purposes will be achieved by performing pilot studies with cohorts of patients.
Read the detailed description
This study is observational with no intervention applied for the patients. In this study, multiple anatomic and functional MRI methods will be performed with three cohorts of patients. In addition to anatomic MRI methods, non-contrast enhanced functional MRI methods will also be applied to evaluate tissue perfusion and vascular reactivity in these patients.
- Conditions
- Chronic Kidney Disease, End-stage Kidney Disease
- Being tested
- No intervention but only observational
- Medical subject headings
- Renal Insufficiency, Chronic, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention but only observationalOther
This study is a cross-sectional and observational MRI study with three cohorts of patients, and no interventions will be applied.
| Study group | Role | What they receive |
|---|---|---|
| Non-CKD (Control) | Patients without CKD (eGFR ≥ 60 ml/min/1.73 mm2) (non-CKD controls).
No intervention but only observational. Receives: Other: No intervention but only observational | |
| CKD (chronic kidney disease) | Patients with Patients with moderate to severe CKD (eGFR ranging from 26 to 44 ml/min/1.73 mm2).
No intervention but only observational. Receives: Other: No intervention but only observational | |
| ESRD (end-stage renal disease) | Patients with advanced CKD (eGFR < 15 ml/min/1.73 mm2), preparing for or undergoing the standard thrice-weekly HD or standard PD treatment (end-stage renal disease (ESRD) patients).
No intervention but only observational. Receives: Other: No intervention but only observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
MRI measured perfusion for each patient group
MRI measurements will be summarized for each patient group by using mean and standard deviation or standard error.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2016 (estimated)
- Study start30 Oct 2025 (estimated)
- Primary completion30 Aug 2026 (estimated)
- Study completion30 Aug 2028 (estimated)
Why it stopped: due to the risk for the patient and later funding issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiufeng Li, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02832505
- Sponsor's protocol ID
- 1603M85321
- Status last verified
- Mar 2025
- First submitted
- 15 Jun 2016
- Last updated
- 25 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Applications of MRI in Kidney Disease
- ClinicalTrials.gov ID
- NCT02832505
- Acronym / sponsor ID
- 1603M85321
- Conditions
- Chronic Kidney Disease, End-stage Kidney Disease
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: due to the risk for the patient and later funding issues
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 30 Oct 2025 (estimated)
- Primary completion
- 30 Aug 2026 (estimated)
- Study completion
- 30 Aug 2028 (estimated)
- First posted
- 14 Jul 2016 (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.
This study has two major purposes:
- To test developed multiple anatomic and functional MRI methods;
- To evaluate the potentials of these MRI methods in the diagnosis, prognosis, and monitoring of the progression of renal dysfunction.
These purposes will be achieved by performing pilot studies with cohorts of patients.
Detailed description
This study is observational with no intervention applied for the patients. In this study, multiple anatomic and functional MRI methods will be performed with three cohorts of patients. In addition to anatomic MRI methods, non-contrast enhanced functional MRI methods will also be applied to evaluate tissue perfusion and vascular reactivity in these patients.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Non-CKD (Control) | – | Other: No intervention but only observationalPatients without CKD (eGFR ≥ 60 ml/min/1.73 mm2) (non-CKD controls). No intervention but only observational. |
| CKD (chronic kidney disease) | – | Other: No intervention but only observationalPatients with Patients with moderate to severe CKD (eGFR ranging from 26 to 44 ml/min/1.73 mm2). No intervention but only observational. |
| ESRD (end-stage renal disease) | – | Other: No intervention but only observationalPatients with advanced CKD (eGFR < 15 ml/min/1.73 mm2), preparing for or undergoing the standard thrice-weekly HD or standard PD treatment (end-stage renal disease (ESRD) patients). No intervention but only observational. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will include three main cohorts of patients: 20 ESRD patients with their transition to dialysis treatment, 20 CKD controls and 20 non-CKD controls. Based on the investigators previous experience, about 20% of recruited subjects may not be able to finish the proposed studies. Therefore, a conservative estimate of the total number of subjects to be recruited is 72.
Key inclusion criteria (3 listed)
- English-speaking as primary language
- Able to complete an approximately 75 to 90 minute cognitive and/or physical tests
- Capable to consent to studies
Key exclusion criteria (6 listed)
- 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
- Renal transplant recipient at time of screening or baseline
- Severe CI unable to complete the Modified Mini-Mental State Examination [3MSE]
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 |
|---|---|---|
| No intervention but only observationalThis study is a cross-sectional and observational MRI study with three cohorts of patients, and no interventions will be applied. | Other | CKD (chronic kidney disease), ESRD (end-stage renal disease), Non-CKD (Control) |
Primary outcome
MRI measured perfusion for each patient group
Time frame: Baseline
MRI measurements will be summarized for each patient group by using mean and standard deviation or standard error.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Xiufeng Li principal investigator
University 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 Disease and End-stage Kidney Disease, 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 3 inclusion and 6 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: withdrawn, as of the sponsor's last update on 25 Mar 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 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MRI measured perfusion for each patient group (time frame: Baseline). 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 25 Mar 2025.