Acute Kidney InjuryNCT06698614
MEMRI and Kidney Disease
An observational study of Acute Kidney Injury and Kidney Transplant, run by University of Edinburgh at 1 site in United Kingdom.
Trial summary
Acute kidney injury (AKI) is common and costly.1 Although patients who suffer an episode of AKI may recover, many will go on to develop cardiovascular disease and chronic kidney disease (CKD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury, Kidney Transplant, Vasculitis
- What is being tested?
- MRI, Blood tests and Urine tests
- Type of treatment
- Injection or infusion
- How many people
- 120 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 7 Nov 2024to 7 Nov 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 years and older
- All sexes
- Adult, Older adult
Study population: Cohort 1- Acute Kidney Injury- 20 patients with acute kidney injury (AKI). AKI diagnosis will be based on clinical and biochemical data reflecting KDIGO criteria. Cohort 2- Chronic Kidney disease (CKD)- 20 age- and sex-matched patients with CKD will be recruited and the patients' eGFR will be matched to that of patients who had AKI and developed persistent renal impairment at the time of their interval scan (3-6 months from their baseline scan). Cohort 3- Control subjects- 20 age-, sex- and cardiovascular risk factor- matched control subjects will be recruited and matched to the AKI cohort. Cohort 4- Vasculitis- 20 patients with a new diagnosis of vasculitis (or an existing diagnosis with relapsing disease), and kidney involvement. Cohort 5- Kidney failure undergoing transplantation.- 20 patients with kidney failure and will receive a kidney transplant in the following 1 month. Cohort 6- Kidney transplant rejection- 20 patients with a biopsy proven diagnosis of transplant
Who may be able to join
- All subjects to be entered must:
- Be able to provide written informed consent after having received oral and written information about the study.
- >18 years of age Availability to complete study visits If female, be non-pregnant as evidenced by a negative pregnancy test or be post-menopausal or surgically sterile.
- Additionally, cohort specific inclusion criteria are as follows:
- Cohort 1; Acute kidney injury-
- A diagnosis of AKI will be made based on the following criteria (based on the definition used in the Kidney Precision Medicine Project www.kpmp.org):
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- Previous (within 3 years) eGFR >45 ml/min/1.73m2 OR no history of kidney disease if no blood results available AND Elevated creatinine >1.5x previous result OR >150 μmol/L if no previous value AND Increasing creatinine within 48 hours OR requirement for dialysis.
- Cohort 2; Chronic kidney disease- Stable CKD for at least 6 months (monitored by eGFR), matched to AKI cohort at follow up based on renal function.
- Cohort 3: Matched controls- Matched to AKI cohort participants at baseline for age, sex, cardiovascular disease risk and cardiovascular medication.
- Cohort 4; Vasculitis- A new diagnosis of vasculitis or an existing diagnosis with relapsing disease, and kidney involvement.
- Cohort 5; Kidney transplantation- Has kidney failure and has received a kidney transplant in the preceding 1 month.
- Cohort 6: Kidney transplant rejection- Biopsy proven episode of transplant rejection.
Who cannot join
- The following criteria apply to all patients:
- Unable to give informed consent.
- Have any contraindications to standard MRI safety criteria, including implanted devices.
- Subjects under the age of 18 years old.
- Pregnancy/positive pregnancy test.
- Current breastfeeding.
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- Have a diagnosis of kidney disease due to polycystic kidney disease.
- Patients in critical care or on surgical wards will be excluded.
- Patients taking calcium channel antagonists or digoxin.
- Additionally, cohort specific exclusion criteria are as follow:
- Cohort 1- Excluded if they have a diagnosis of diabetes. Cohort 2- Excluded if receiving dialysis or those with a functional kidney transplant, multi-system disorders (e.g., systemic vasculitis), or any patients receiving immunosuppression.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Neeraj Dhaun contact
United Kingdom1 site, 1 recruiting
- Recruiting
NHS Lothian
Edinburgh
Hannah Preston, MBCHb, 447889742171, v1hprest@ed.ac.uk
Neeraj Dhaun, MBCHb, bean.dhaun@ed.ac.uk
About this study
Official title: Manganese-Enhanced Magnetic Resonance Imaging (MEMRI) in Patients With Kidney Disease
Acute kidney injury (AKI) is common and costly.1 Although patients who suffer an episode of AKI may recover, many will go on to develop cardiovascular disease and chronic kidney disease (CKD). Cardiovascular disease is an important complication of AKI.2 Similar to AKI, CKD and kidney transplantation and kidney donation associations with cardiovascular disease.1 The risk of cardiovascular disease complications is also increased in patients with inflammatory diseases that affect the kidneys, such as vasculitis.
Currently, there are no reliable biomarkers that will identify those patients with kidney disease that will go on to develop cardiovascular disease. This study will explore the potential of manganese-enhanced magnetic resonance imaging (MEMRI) to act as a biomarker of AKI and its cardiovascular and renal complications. An analogue of calcium, manganese is readily taken-up into viable cells where it increases T1 relaxivity. Preliminary data show rapid manganese uptake in the heart and kidneys of healthy subjects.
The investigators propose to use MEMRI to demonstrate differences in renal and myocardial calcium handling in patients with acute insults (such as AKI, transplant rejection, donation or episodes of rejection or new vasculitis presentations) or improvements (such as transplantation). The investigators will also investigate whether these abnormalities reverse in those whose injury resolves or persist in those who clearly develop CKD, or who are at risk of future cardiovascular disease and CKD.
- Being tested
- MRI, Blood tests, Urine tests, Cardiovascular analysis
- Keywords
- manganese enhanced magnetic resonance imaging, kidney disease, MEMRI, Manganese enhanced MRI
- Medical subject headings
- Acute Kidney Injury, Vasculitis, Renal Insufficiency, Chronic, Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIDiagnostic test
MRI imaging of the kidney and heart with an intravenous infusion of manganese dipyridoxl diphosphate (Mangafodipir, MnDPDP).
Blood testsDiagnostic test
full blood count, urea and electrolytes, liver function test, CRP, biomarkers for endothelial function, storage of serum and plasma for future analyses.
Urine testsDiagnostic test
Urine protein, Urine creatinine
Cardiovascular analysisDiagnostic test
24 hour blood pressure, arterial stiffness
| Study group | Role | What they receive |
|---|---|---|
| Acute Kidney Injury | 20 patients with acute kidney injury (AKI). AKI diagnosis will be based on clinical and biochemical data reflecting KDIGO criteria. Receives: Diagnostic Test: MRI; Diagnostic Test: Blood tests; Diagnostic Test: Urine tests; Diagnostic Test: Cardiovascular analysis | |
| Chronic Kidney Disease | 20 age- and sex-matched patients with CKD will be recruited and the patients' eGFR will be matched to that of patients who had AKI and developed persistent renal impairment at the time of their interval scan (3-6 months from their baseline scan). Receives: Diagnostic Test: MRI; Diagnostic Test: Blood tests; Diagnostic Test: Urine tests; Diagnostic Test: Cardiovascular analysis | |
| Control Subjects | 20 age-, sex- and cardiovascular risk factor- matched control subjects will be recruited and matched to the AKI cohort Receives: Diagnostic Test: MRI; Diagnostic Test: Blood tests; Diagnostic Test: Urine tests; Diagnostic Test: Cardiovascular analysis | |
| Vasculitis | 20 patients with a new diagnosis of vasculitis (or an existing diagnosis with relapsing disease), and kidney involvement Receives: Diagnostic Test: MRI; Diagnostic Test: Blood tests; Diagnostic Test: Urine tests; Diagnostic Test: Cardiovascular analysis | |
| Kidney failure undergoing transplantation | 20 patients with kidney failure and will receive a kidney transplant in 1 month Receives: Diagnostic Test: MRI; Diagnostic Test: Blood tests; Diagnostic Test: Urine tests; Diagnostic Test: Cardiovascular analysis | |
| Kidney transplant rejection | 20 patients with a biopsy proven diagnosis of transplant rejection Receives: Diagnostic Test: MRI; Diagnostic Test: Blood tests; Diagnostic Test: Urine tests; Diagnostic Test: Cardiovascular analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Manganese Uptake (Ki)
Rate of manganese uptake in the kidney (cortex and medulla) and myocardium
Measured: (baseline and follow up scan in relevant cohorts)
Secondary outcomes (3)
24 hour blood pressure
Measured: baseline and follow up
Arterial stiffness.
Measure of arterial stiffness
Measured: baseline and follow up
Biomarkers of endothelial function
Measured: baseline and follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2024
- Study start7 Nov 2024
- Primary completion7 Nov 2029 (estimated)
- Study completion7 Nov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Kidney InjuryStudies 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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Collaborators
- NHS Lothian
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06698614
- Sponsor's protocol ID
- 23/WA/0276
- Status last verified
- Dec 2025
- First submitted
- 18 Nov 2024
- Last updated
- 8 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Anonymised data after the end of the study will be disseminated in the public domain through the form of publications. Raw data will be retained within the study team and those researchers who will be continuing the study or further expanding the use of MEMRI will have access to this data. Anonymised data will be shared with external collaborators and scientists, subject to governance approvals.
Publications
Legrand M, Rossignol P. Cardiovascular Consequences of Acute Kidney Injury. N Engl J Med. 2020 Jun 4;382(23):2238-2247. doi: 10.1056/NEJMra1916393. No abstract available.
PubMed 32492305Bellomo R, Kellum JA, Ronco C. Acute kidney injury. Lancet. 2012 Aug 25;380(9843):756-66. doi: 10.1016/S0140-6736(11)61454-2. Epub 2012 May 21.
PubMed 22617274
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Manganese-Enhanced Magnetic Resonance Imaging (MEMRI) in Patients With Kidney Disease
- ClinicalTrials.gov ID
- NCT06698614
- Acronym / sponsor ID
- 23/WA/0276
- Keywords
- manganese enhanced magnetic resonance imaging, kidney disease, MEMRI, Manganese enhanced MRI
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Collaborators
- NHS Lothian
- Study start
- 7 Nov 2024 (actual)
- Primary completion
- 7 Nov 2029 (estimated)
- Study completion
- 7 Nov 2029 (estimated)
- First posted
- 21 Nov 2024 (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.
Acute kidney injury (AKI) is common and costly.1 Although patients who suffer an episode of AKI may recover, many will go on to develop cardiovascular disease and chronic kidney disease (CKD). Cardiovascular disease is an important complication of AKI.2 Similar to AKI, CKD and kidney transplantation and kidney donation associations with cardiovascular disease.1 The risk of cardiovascular disease complications is also increased in patients with inflammatory diseases that affect the kidneys, such as vasculitis.
Currently, there are no reliable biomarkers that will identify those patients with kidney disease that will go on to develop cardiovascular disease. This study will explore the potential of manganese-enhanced magnetic resonance imaging (MEMRI) to act as a biomarker of AKI and its cardiovascular and renal complications. An analogue of calcium, manganese is readily taken-up into viable cells where it increases T1 relaxivity. Preliminary data show rapid manganese uptake in the heart and kidneys of healthy subjects.
The investigators propose to use MEMRI to demonstrate differences in renal and myocardial calcium handling in patients with acute insults (such as AKI, transplant rejection, donation or episodes of rejection or new vasculitis presentations) or improvements (such as transplantation). The investigators will also investigate whether these abnormalities reverse in those whose injury resolves or persist in those who clearly develop CKD, or who are at risk of future cardiovascular disease and CKD.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Acute Kidney Injury | – | Diagnostic Test: MRI, Diagnostic Test: Blood tests, Diagnostic Test: Urine tests, Diagnostic Test: Cardiovascular analysis20 patients with acute kidney injury (AKI). AKI diagnosis will be based on clinical and biochemical data reflecting KDIGO criteria. |
| Chronic Kidney Disease | – | Diagnostic Test: MRI, Diagnostic Test: Blood tests, Diagnostic Test: Urine tests, Diagnostic Test: Cardiovascular analysis20 age- and sex-matched patients with CKD will be recruited and the patients' eGFR will be matched to that of patients who had AKI and developed persistent renal impairment at the time of their interval scan (3-6 months from their baseline scan). |
| Control Subjects | – | Diagnostic Test: MRI, Diagnostic Test: Blood tests, Diagnostic Test: Urine tests, Diagnostic Test: Cardiovascular analysis20 age-, sex- and cardiovascular risk factor- matched control subjects will be recruited and matched to the AKI cohort |
| Vasculitis | – | Diagnostic Test: MRI, Diagnostic Test: Blood tests, Diagnostic Test: Urine tests, Diagnostic Test: Cardiovascular analysis20 patients with a new diagnosis of vasculitis (or an existing diagnosis with relapsing disease), and kidney involvement |
| Kidney failure undergoing transplantation | – | Diagnostic Test: MRI, Diagnostic Test: Blood tests, Diagnostic Test: Urine tests, Diagnostic Test: Cardiovascular analysis20 patients with kidney failure and will receive a kidney transplant in 1 month |
| Kidney transplant rejection | – | Diagnostic Test: MRI, Diagnostic Test: Blood tests, Diagnostic Test: Urine tests, Diagnostic Test: Cardiovascular analysis20 patients with a biopsy proven diagnosis of transplant rejection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Cohort 1- Acute Kidney Injury- 20 patients with acute kidney injury (AKI). AKI diagnosis will be based on clinical and biochemical data reflecting KDIGO criteria. Cohort 2- Chronic Kidney disease (CKD)- 20 age- and sex-matched patients with CKD will be recruited and the patients' eGFR will be matched to that of patients who had AKI and developed persistent renal impairment at the time of their interval scan (3-6 months from their baseline scan). Cohort 3- Control subjects- 20 age-, sex- and cardiovascular risk factor- matched control subjects will be recruited and matched to the AKI cohort. Cohort 4- Vasculitis- 20 patients with a new diagnosis of vasculitis (or an existing diagnosis with relapsing disease), and kidney involvement. Cohort 5- Kidney failure undergoing transplantation.- 20 patients with kidney failure and will receive a kidney transplant in the following 1 month. Cohort 6- Kidney transplant rejection- 20 patients with a biopsy proven diagnosis of transplant
Key inclusion criteria (12 listed)
- Be able to provide written informed consent after having received oral and written information about the study.
- >18 years of age Availability to complete study visits If female, be non-pregnant as evidenced by a negative pregnancy test or be post-menopausal or surgically sterile.
- Cohort 1; Acute kidney injury-
- A diagnosis of AKI will be made based on the following criteria (based on the definition used in the Kidney Precision Medicine Project www.kpmp.org):
- Previous (within 3 years) eGFR >45 ml/min/1.73m2 OR no history of kidney disease if no blood results available AND Elevated creatinine >1.5x previous result OR >150 μmol/L if no previous value AND Increasing creatinine within 48 hours OR requirement for dialysis.
Key exclusion criteria (11 listed)
- Unable to give informed consent.
- Have any contraindications to standard MRI safety criteria, including implanted devices.
- Subjects under the age of 18 years old.
- Pregnancy/positive pregnancy test.
- Current breastfeeding.
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 |
|---|---|---|
| MRIMRI imaging of the kidney and heart with an intravenous infusion of manganese dipyridoxl diphosphate (Mangafodipir, MnDPDP). | Diagnostic test | Acute Kidney Injury, Chronic Kidney Disease, Control Subjects, Kidney failure undergoing transplantation, Kidney transplant rejection, Vasculitis |
| Blood testsfull blood count, urea and electrolytes, liver function test, CRP, biomarkers for endothelial function, storage of serum and plasma for future analyses. | Diagnostic test | Acute Kidney Injury, Chronic Kidney Disease, Control Subjects, Kidney failure undergoing transplantation, Kidney transplant rejection, Vasculitis |
| Urine testsUrine protein, Urine creatinine | Diagnostic test | Acute Kidney Injury, Chronic Kidney Disease, Control Subjects, Kidney failure undergoing transplantation, Kidney transplant rejection, Vasculitis |
| Cardiovascular analysis24 hour blood pressure, arterial stiffness | Diagnostic test | Acute Kidney Injury, Chronic Kidney Disease, Control Subjects, Kidney failure undergoing transplantation, Kidney transplant rejection, Vasculitis |
Primary outcome
Manganese Uptake (Ki)
Time frame: (baseline and follow up scan in relevant cohorts)
Rate of manganese uptake in the kidney (cortex and medulla) and myocardium
3 secondary outcomes
24 hour blood pressure
Time frame: baseline and follow up
Arterial stiffness.
Time frame: baseline and follow up
Biomarkers of endothelial function
Time frame: baseline and follow up
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 8 Dec 2025.
- Background: PubMed 32492305Legrand M, Rossignol P. Cardiovascular Consequences of Acute Kidney Injury. N Engl J Med. 2020 Jun 4;382(23):2238-2247. doi: 10.1056/NEJMra1916393. No abstract available.
- Background: PubMed 22617274Bellomo R, Kellum JA, Ronco C. Acute kidney injury. Lancet. 2012 Aug 25;380(9843):756-66. doi: 10.1016/S0140-6736(11)61454-2. Epub 2012 May 21.
- Individual participant dataSharing planned: No. Anonymised data after the end of the study will be disseminated in the public domain through the form of publications. Raw data will be retained within the study team and those researchers who will be continuing the study or further expanding the use of MEMRI will have access to this data. Anonymised data will be shared with external collaborators and scientists, subject to governance approvals.
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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.
Neeraj Dhaun 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 Acute Kidney Injury and Kidney Transplant, run by University of Edinburgh at 1 site in United Kingdom.
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 12 inclusion and 11 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 8 Dec 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 Kingdom. 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 Hannah Preston, MBCHb (447889742171, v1hprest@ed.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Manganese Uptake (Ki) (time frame: (baseline and follow up scan in relevant cohorts)). 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 NCT06698614, which also lists 2 linked publications.
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 8 Dec 2025.