Kidney TransplantationNCT04899167
Noninvasive Evaluation of Renal Allograft Fibrosis by MRI
A study testing MRI 1.5T and 3.0T in people with Kidney Transplantation, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is to validate an MRI method to detect renal fibrosis in patients after kidney transplantation (KT). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Kidney Transplantation
- What is being tested?
- MRI 1.5T and 3.0T
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2021to 30 Aug 2023
- Phase
- Interventional
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-80 years
- Recipient of living donor kidney transplantation 4 or 7 years earlier
- Competent and able to provide written informed consent; Ability to comply with protocol
Who cannot join
- Patients have clinically significant medical conditions within the prior 6 months before: e.g. myocardial infarction, congestive heart failure, stroke, that would, in the opinion of the investigators, compromise the safety of the patient.
- Severe chronic liver, heart or lung disease
- Undergoing acute rejection
- Contra-indication to biopsy; bleeding disorders
- Chronic infection
- Any active malignancy and undergoing therapy
Show all 12Show fewer
- Kidney or ureteric stone
- Unable to give valid informed consent
- Known pregnancy or intent to conceive during the study period
- Pacemaker, implantable defibrillator, magnetically active metal fragments, claustrophobia or other contraindication to MRI
- Federal medical center inmates.
- Latex allergy
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
The purpose of this study is to validate an MRI method to detect renal fibrosis in patients after kidney transplantation (KT).
Read the detailed description
The hypothesis underlying this proposal is that qMT reliably detects development of allograft fibrosis in human subjects after KT. To test this hypothesis, the qMT-derived bound pool fraction will be correlated with renal fibrosis as per biopsy in 20 patients 4 or 7 years after living donor KT. The bound pool fraction will also be compared to renal blood flow, oxygenation, and function, and the ability of qMT to provide consistent assessments of fibrosis tested at different magnetic field strengths. Two specific aims will test the hypotheses that: Specific Aim 1: qMT provides reliable and consequential assessment of fibrosis in human kidney allografts. Specific Aim 2: Renal fibrosis assessed by qMT in human kidney allografts is reproducible at 1.5 T and 3.0 T.
- Conditions
- Kidney Transplantation
- Being tested
- MRI 1.5T and 3.0T
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI 1.5T and 3.0TOther
Magnetic Resonance Imaging for Renal Fibrosis
| Study group | Role | What they receive |
|---|---|---|
| 4 years after kidney transplantation | Experimental | Patients 4 years after KT (N=10); 5 with estimated (e) glomerular filtration rate (GFR) ≤35 mL/min/1.73m2, and 5 with estimated (e) glomerular filtration rate (GFR)>35 mL/min/1.73m2. Receives: Other: MRI 1.5T and 3.0T |
| 7 years after kidney transplantation | Experimental | Patients 7 years after KT (N=10); 5 patients with eGFR ≤35 mL/min/1.73m2, and 5 with eGFR>35 mL/min/1.73m2. Receives: Other: MRI 1.5T and 3.0T |
What is being measured
The primary outcome is the main question the study is designed to answer.
The values and correlation of f with IF
Correlation of qMT with tissue fibrosis (trichrome)
Measured: 2 years
Secondary outcomes (1)
The correlation of f with renal function attributes and pro-fibrogenic activity
Correlation of qMT with renal oxygenation, GFR, levels of fibrogenic factors.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2021
- Study start1 Aug 2021
- Primary completion30 Aug 2023
- Study completion30 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney TransplantationStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, unblinded, Parallel, imaging study
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Lilach O Lerman, Mayo Clinic
- Investigators
- Lilach Lerman, MD, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04899167
- Sponsor's protocol ID
- 19-008333
- Other IDs
- R21AG062104
- Status last verified
- Oct 2023
- First submitted
- 19 May 2021
- Last updated
- 5 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Noninvasive Evaluation of Renal Allograft Fibrosis by MRI
- ClinicalTrials.gov ID
- NCT04899167
- Acronym / sponsor ID
- 19-008333
- Conditions
- Kidney Transplantation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 30 Aug 2023 (actual)
- Study completion
- 30 Aug 2023 (actual)
- First posted
- 24 May 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 purpose of this study is to validate an MRI method to detect renal fibrosis in patients after kidney transplantation (KT).
Detailed description
The hypothesis underlying this proposal is that qMT reliably detects development of allograft fibrosis in human subjects after KT. To test this hypothesis, the qMT-derived bound pool fraction will be correlated with renal fibrosis as per biopsy in 20 patients 4 or 7 years after living donor KT. The bound pool fraction will also be compared to renal blood flow, oxygenation, and function, and the ability of qMT to provide consistent assessments of fibrosis tested at different magnetic field strengths. Two specific aims will test the hypotheses that: Specific Aim 1: qMT provides reliable and consequential assessment of fibrosis in human kidney allografts. Specific Aim 2: Renal fibrosis assessed by qMT in human kidney allografts is reproducible at 1.5 T and 3.0 T.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, unblinded, Parallel, imaging study
| Arm | Type | Receives |
|---|---|---|
| 4 years after kidney transplantation | Experimental | Other: MRI 1.5T and 3.0TPatients 4 years after KT (N=10); 5 with estimated (e) glomerular filtration rate (GFR) ≤35 mL/min/1.73m2, and 5 with estimated (e) glomerular filtration rate (GFR)>35 mL/min/1.73m2. |
| 7 years after kidney transplantation | Experimental | Other: MRI 1.5T and 3.0TPatients 7 years after KT (N=10); 5 patients with eGFR ≤35 mL/min/1.73m2, and 5 with eGFR>35 mL/min/1.73m2. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18-80 years
- Recipient of living donor kidney transplantation 4 or 7 years earlier
- Competent and able to provide written informed consent; Ability to comply with protocol
Key exclusion criteria (12 listed)
- Patients have clinically significant medical conditions within the prior 6 months before: e.g. myocardial infarction, congestive heart failure, stroke, that would, in the opinion of the investigators, compromise the safety of the patient.
- Severe chronic liver, heart or lung disease
- Undergoing acute rejection
- Contra-indication to biopsy; bleeding disorders
- Chronic infection
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 |
|---|---|---|
| MRI 1.5T and 3.0TMagnetic Resonance Imaging for Renal Fibrosis | Other | 4 years after kidney transplantation, 7 years after kidney transplantation |
Primary outcome
The values and correlation of f with IF
Time frame: 2 years
Correlation of qMT with tissue fibrosis (trichrome)
1 secondary outcome
The correlation of f with renal function attributes and pro-fibrogenic activity
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2023.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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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.
Lilach Lerman, MD, PhD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI 1.5T and 3.0T in people with Kidney Transplantation, run by Mayo Clinic 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 12 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: finished, as of the sponsor's last update on 5 Oct 2023. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The values and correlation of f with IF (time frame: 2 years). 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 5 Oct 2023.