MEMRI and Kidney Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Edinburgh
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
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.
Trial 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
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
MRI
Diagnostic testMRI imaging of the kidney and heart with an intravenous infusion of manganese dipyridoxl diphosphate (Mangafodipir, MnDPDP).
Blood tests
Diagnostic testfull blood count, urea and electrolytes, liver function test, CRP, biomarkers for endothelial function, storage of serum and plasma for future analyses.
Urine tests
Diagnostic testUrine protein, Urine creatinine
Cardiovascular analysis
Diagnostic test24 hour blood pressure, arterial stiffness
Treatment groups
120 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Group A: Acute Kidney Injury4 interventions
Group B: Chronic Kidney Disease4 interventions
Group C: Control Subjects4 interventions
Group D: Vasculitis4 interventions
Group E: Kidney failure undergoing transplantation4 interventions
Group F: Kidney transplant rejection4 interventions
Trial outcomes
Primary outcomes
1
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)Secondary outcomes
1
24 hour blood pressure
Time frame
baseline and follow up2
Arterial stiffness.
Measure of arterial stiffness
Time frame
baseline and follow up3
Biomarkers of endothelial function
Time frame
baseline and follow upSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Edinburgh
Lead sponsor
NHS Lothian
Collaborator
Source ClinicalTrials.gov