An observational study in Acute Kidney Injury, Kidney Transplant and Vasculitis, sponsored by University of Edinburgh. Recruiting at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-08.
Sponsored by University of Edinburgh · Observational
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.
1,691 studies on the registry are indexed under Acute Kidney Injury; 395 are open to participants now.
This study's planned enrollment of 120 is below the median of 160 across 814 observational studies indexed under Acute Kidney Injury.
Browse Acute Kidney Injury studies →University of Edinburgh is the lead sponsor of 403 studies on the registry; 64 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
All subjects to be entered must:
Be able to provide written 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 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):
Previous (within 3 years) >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- proven episode of transplant rejection.
Exclusion Criteria:
The following criteria apply to all patients:
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 .
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
20 patients with acute kidney injury (AKI). AKI diagnosis will be based on clinical and biochemical data reflecting KDIGO criteria.
Diagnostic Test: MRI · Diagnostic Test: Blood tests · Diagnostic Test: Urine tests · Diagnostic Test: Cardiovascular analysis
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).
Diagnostic Test: MRI · Diagnostic Test: Blood tests · Diagnostic Test: Urine tests · Diagnostic Test: Cardiovascular analysis
20 age-, sex- and cardiovascular risk factor- matched control subjects will be recruited and matched to the AKI cohort
Diagnostic Test: MRI · Diagnostic Test: Blood tests · Diagnostic Test: Urine tests · Diagnostic Test: Cardiovascular analysis
20 patients with a new diagnosis of vasculitis (or an existing diagnosis with relapsing disease), and kidney involvement
Diagnostic Test: MRI · Diagnostic Test: Blood tests · Diagnostic Test: Urine tests · Diagnostic Test: Cardiovascular analysis
20 patients with kidney failure and will receive a kidney transplant in 1 month
Diagnostic Test: MRI · Diagnostic Test: Blood tests · Diagnostic Test: Urine tests · Diagnostic Test: Cardiovascular analysis
20 patients with a biopsy proven diagnosis of transplant rejection
Diagnostic Test: MRI · Diagnostic Test: Blood tests · Diagnostic Test: Urine tests · Diagnostic Test: Cardiovascular analysis
MRI imaging of the kidney and heart with an intravenous infusion of manganese dipyridoxl diphosphate (Mangafodipir, MnDPDP).
full blood count, urea and electrolytes, liver function test, CRP, biomarkers for endothelial function, storage of serum and plasma for future analyses.
Urine protein, Urine creatinine
24 hour blood pressure, arterial stiffness
Manganese Uptake (Ki)
Rate of manganese uptake in the kidney (cortex and medulla) and myocardium
Time frame: (baseline and follow up scan in relevant cohorts)
24 hour blood pressure
Time frame: baseline and follow up
Arterial stiffness.
Measure of arterial stiffness
Time frame: baseline and follow up
Biomarkers of endothelial function
Time frame: baseline and follow up
Plan to share: 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.
Started Nov 2024 (actual). Primary completion is estimated for Nov 2029, 60 months after the start.
Of 349 non-industry observational studies under Acute Kidney Injury, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 42. This study's planned 60 months is above that.
Counting every sponsor, half of 364 studies reached it within 24 months; a quarter within 12 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
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