Renal Transplant RejectionNCT03192007
Multi-Parametric MRI for Renal Transplantation
An observational study of Renal Transplant Rejection, run by University of Minnesota at 1 site in United States.
Trial summary
The goals of this study are: To optimize and evaluate multiple kidney MRI methods; and To investigate the potential of MRI in the assessment of transplant kidney functions; To achieve these goals, we will perform pilot MRI studies with kidney transplant patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Renal Transplant Rejection
- What is being tested?
- Magnetic Resonance Imaging
- Type of treatment
- Medical device
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2027to 31 Dec 2028
- 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 75 years
- All sexes
- Adult, Older adult
Study population: The proposed studies are pilot studies to obtain preliminary data for the development of hypotheses and estimate the power for future large-scale studies. To accomplish the objectives of the proposed pilot studies, we will enroll a total of 140 renal transplant patients. Based on our previous experience, there will be about 20% patients who may withdraw after informed consent. Equal number of male and female subjects will be recruited for each patient group. In addition, the age of patients will be matched or ensured insignificant across the groups of the study objectives.
Who may be able to join
- Renal Transplant Recipients
- Capable to consent
- English speaking
- For studies with patients with fast worsening renal function: An abrupt (within 48 h) reduction in kidney function currently defined as a percentage increase in serum creatinine of ≥50% (1.5-fold from baseline), or a reduction in urine output (documented oliguria of less than 0.5 mL/kg/h for more than 6 h).
- For patients with recovered renal allograft function after therapy: renal allograft function as measured by glomerular filtration rate (eGRF) has been recovered and stabilized above a clinical acceptable level, such as 15 ml/min/1.73 mm2.
Who cannot join
- On dialysis due to renal allograft failure
- Acute and chronic pulmonary disease
- Pregnancy as reported in CMRR Safety Screen
- Ferromagnetic implants
- Any foreign metal objects in the body
- History of shrapnel or shot gun injury
Show all 14Show fewer
- Cardiac pacemakers
- Defibrillator
- Neuronal stimulator
- Magnetic aneurysm clip
- Large tattoos on the abdomen or the brain and neck, as determined by CMRR Safety Officer
- Hip replacement
- Too large to fit in the magnet (BMI >= 40, approx.)
- Severe claustrophobia
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
The goals of this study are:
- To optimize and evaluate multiple kidney MRI methods; and
- To investigate the potential of MRI in the assessment of transplant kidney functions; To achieve these goals, we will perform pilot MRI studies with kidney transplant patients. We will study if MRI can reflect different levels of kidney function. The investigators will also evaluate if MRI can differentiate causes for declining kidney function. Finally, the investigators will explore how MRI measures changes before and after medical treatment for worsening kidney function.
You may be invited for MRI exams with different exam options. An MRI exam may use either of two types of MRI machines at the center for magnetic resonance research (CMRR): the 3 Tesla (3T) scanner and the 7 Tesla (7T) scanner. You may also be invited for a multi-session exam. A description of the MRI exam types with different exam options and the types of multi-session exams is provided later in this document.
Read the detailed description
To achieve these goals, the investigators will perform pilot MRI studies with kidney transplant patients. The investigators will study if MRI can reflect different levels of kidney function. The investigators will also evaluate if MRI can differentiate causes for declining kidney function. Finally, the investigators will explore how MRI measures changes before and after medical treatment for worsening kidney function.
Subjects may be invited for MRI exams with different exam options. An MRI exam may use either of two types of MRI machines at the CMRR: the 3T scanner and the 7T scanner. Subjects may also be invited for a multi-session exam. A description of the MRI exam types with different exam options and the types of multi-session exams is provided later in this document.
- Conditions
- Renal Transplant Rejection
- Being tested
- Magnetic Resonance Imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance ImagingDevice
Also called MRI
Investigate anatomic and functional characteristics of transplant kidneys using MRI
| Study group | Role | What they receive |
|---|---|---|
| Patients with Stable Renal Function | Patients will be given MRI Receives: Device: Magnetic Resonance Imaging | |
| Patients with Worsening Renal Function due to complications | MRI Receives: Device: Magnetic Resonance Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anatomic and functional MRI characteristics in transplant kidneys with stable renal function
Investigate the correlations between anatomic and functional characteristics by MRI and the level of transplant renal function
Measured: Baseline
Secondary outcomes (1)
Anatomic and functional MRI characteristics of transplant kidneys with transplant complications
Investigate the anatomic and functional MRI characteristics of transplant kidneys with transplant complications with comparisons with those from transplant kidneys having stable renal function
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2017
- Study start1 Jul 2027 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Transplant RejectionStudies 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
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03192007
- Sponsor's protocol ID
- 1610M96261
- Status last verified
- Sep 2026
- First submitted
- 9 May 2017
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Parametric MRI for Renal Transplantation
- ClinicalTrials.gov ID
- NCT03192007
- Acronym / sponsor ID
- 1610M96261
- Conditions
- Renal Transplant Rejection
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 1 Jul 2027 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 19 Jun 2017 (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 goals of this study are:
- To optimize and evaluate multiple kidney MRI methods; and
- To investigate the potential of MRI in the assessment of transplant kidney functions; To achieve these goals, we will perform pilot MRI studies with kidney transplant patients. We will study if MRI can reflect different levels of kidney function. The investigators will also evaluate if MRI can differentiate causes for declining kidney function. Finally, the investigators will explore how MRI measures changes before and after medical treatment for worsening kidney function.
You may be invited for MRI exams with different exam options. An MRI exam may use either of two types of MRI machines at the center for magnetic resonance research (CMRR): the 3 Tesla (3T) scanner and the 7 Tesla (7T) scanner. You may also be invited for a multi-session exam. A description of the MRI exam types with different exam options and the types of multi-session exams is provided later in this document.
Detailed description
To achieve these goals, the investigators will perform pilot MRI studies with kidney transplant patients. The investigators will study if MRI can reflect different levels of kidney function. The investigators will also evaluate if MRI can differentiate causes for declining kidney function. Finally, the investigators will explore how MRI measures changes before and after medical treatment for worsening kidney function.
Subjects may be invited for MRI exams with different exam options. An MRI exam may use either of two types of MRI machines at the CMRR: the 3T scanner and the 7T scanner. Subjects may also be invited for a multi-session exam. A description of the MRI exam types with different exam options and the types of multi-session exams is provided later in this document.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with Stable Renal Function | – | Device: Magnetic Resonance ImagingPatients will be given MRI |
| Patients with Worsening Renal Function due to complications | – | Device: Magnetic Resonance ImagingMRI |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The proposed studies are pilot studies to obtain preliminary data for the development of hypotheses and estimate the power for future large-scale studies. To accomplish the objectives of the proposed pilot studies, we will enroll a total of 140 renal transplant patients. Based on our previous experience, there will be about 20% patients who may withdraw after informed consent. Equal number of male and female subjects will be recruited for each patient group. In addition, the age of patients will be matched or ensured insignificant across the groups of the study objectives.
Key inclusion criteria (5 listed)
- Renal Transplant Recipients
- Capable to consent
- English speaking
- For studies with patients with fast worsening renal function: An abrupt (within 48 h) reduction in kidney function currently defined as a percentage increase in serum creatinine of ≥50% (1.5-fold from baseline), or a reduction in urine output (documented oliguria of less than 0.5 mL/kg/h for more than 6 h).
- For patients with recovered renal allograft function after therapy: renal allograft function as measured by glomerular filtration rate (eGRF) has been recovered and stabilized above a clinical acceptable level, such as 15 ml/min/1.73 mm2.
Key exclusion criteria (14 listed)
- On dialysis due to renal allograft failure
- Acute and chronic pulmonary disease
- Pregnancy as reported in CMRR Safety Screen
- Ferromagnetic implants
- Any foreign metal objects in the body
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 |
|---|---|---|
| Magnetic Resonance ImagingAlso: MRIInvestigate anatomic and functional characteristics of transplant kidneys using MRI | Device | Patients with Stable Renal Function, Patients with Worsening Renal Function due to complications |
Primary outcome
Anatomic and functional MRI characteristics in transplant kidneys with stable renal function
Time frame: Baseline
Investigate the correlations between anatomic and functional characteristics by MRI and the level of transplant renal function
1 secondary outcome
Anatomic and functional MRI characteristics of transplant kidneys with transplant complications
Time frame: Baseline
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 16 Sep 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Renal Transplant Rejection, 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 5 inclusion and 14 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 16 Sep 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?
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?
Anatomic and functional MRI characteristics in transplant kidneys with stable renal function (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 16 Sep 2026.