Study Results
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Basic Information
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RECRUITING
120 participants
OBSERVATIONAL
2024-11-07
2029-11-07
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Acute Kidney Injury
20 patients with acute kidney injury (AKI). AKI diagnosis will be based on clinical and biochemical data reflecting KDIGO criteria.
MRI
MRI imaging of the kidney and heart with an intravenous infusion of manganese dipyridoxl diphosphate (Mangafodipir, MnDPDP).
Blood tests
full blood count, urea and electrolytes, liver function test, CRP, biomarkers for endothelial function, storage of serum and plasma for future analyses.
Urine tests
Urine protein, Urine creatinine
Cardiovascular analysis
24 hour blood pressure, arterial stiffness
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).
MRI
MRI imaging of the kidney and heart with an intravenous infusion of manganese dipyridoxl diphosphate (Mangafodipir, MnDPDP).
Blood tests
full blood count, urea and electrolytes, liver function test, CRP, biomarkers for endothelial function, storage of serum and plasma for future analyses.
Urine tests
Urine protein, Urine creatinine
Cardiovascular analysis
24 hour blood pressure, arterial stiffness
Control Subjects
20 age-, sex- and cardiovascular risk factor- matched control subjects will be recruited and matched to the AKI cohort
MRI
MRI imaging of the kidney and heart with an intravenous infusion of manganese dipyridoxl diphosphate (Mangafodipir, MnDPDP).
Blood tests
full blood count, urea and electrolytes, liver function test, CRP, biomarkers for endothelial function, storage of serum and plasma for future analyses.
Urine tests
Urine protein, Urine creatinine
Cardiovascular analysis
24 hour blood pressure, arterial stiffness
Vasculitis
20 patients with a new diagnosis of vasculitis (or an existing diagnosis with relapsing disease), and kidney involvement
MRI
MRI imaging of the kidney and heart with an intravenous infusion of manganese dipyridoxl diphosphate (Mangafodipir, MnDPDP).
Blood tests
full blood count, urea and electrolytes, liver function test, CRP, biomarkers for endothelial function, storage of serum and plasma for future analyses.
Urine tests
Urine protein, Urine creatinine
Cardiovascular analysis
24 hour blood pressure, arterial stiffness
Kidney failure undergoing transplantation
20 patients with kidney failure and will receive a kidney transplant in 1 month
MRI
MRI imaging of the kidney and heart with an intravenous infusion of manganese dipyridoxl diphosphate (Mangafodipir, MnDPDP).
Blood tests
full blood count, urea and electrolytes, liver function test, CRP, biomarkers for endothelial function, storage of serum and plasma for future analyses.
Urine tests
Urine protein, Urine creatinine
Cardiovascular analysis
24 hour blood pressure, arterial stiffness
Kidney transplant rejection
20 patients with a biopsy proven diagnosis of transplant rejection
MRI
MRI imaging of the kidney and heart with an intravenous infusion of manganese dipyridoxl diphosphate (Mangafodipir, MnDPDP).
Blood tests
full blood count, urea and electrolytes, liver function test, CRP, biomarkers for endothelial function, storage of serum and plasma for future analyses.
Urine tests
Urine protein, Urine creatinine
Cardiovascular analysis
24 hour blood pressure, arterial stiffness
Interventions
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MRI
MRI imaging of the kidney and heart with an intravenous infusion of manganese dipyridoxl diphosphate (Mangafodipir, MnDPDP).
Blood tests
full blood count, urea and electrolytes, liver function test, CRP, biomarkers for endothelial function, storage of serum and plasma for future analyses.
Urine tests
Urine protein, Urine creatinine
Cardiovascular analysis
24 hour blood pressure, arterial stiffness
Eligibility Criteria
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Inclusion Criteria
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.
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.
Exclusion Criteria
1. Unable to give informed consent.
2. Have any contraindications to standard MRI safety criteria, including implanted devices.
3. Subjects under the age of 18 years old.
4. Pregnancy/positive pregnancy test.
5. Current breastfeeding.
6. Have a diagnosis of kidney disease due to polycystic kidney disease.
7. Patients in critical care or on surgical wards will be excluded.
8. Patients taking calcium channel antagonists or digoxin.
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.
18 Years
ALL
No
Sponsors
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NHS Lothian
OTHER_GOV
University of Edinburgh
OTHER
Responsible Party
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Locations
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NHS Lothian
Edinburgh, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Bellomo 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.
Other Identifiers
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23/WA/0276
Identifier Type: -
Identifier Source: org_study_id
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