MEMRI and Kidney Disease

Sponsor
University of Edinburgh
Study ID
NCT06698614
Status
Recruiting
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Conditions

  • Acute Kidney Injury
  • Chronic Kidney Disease(CKD)
  • Kidney Transplant
  • Vasculitis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • MRI — DIAGNOSTIC_TEST
    MRI imaging of the kidney and heart with an intravenous infusion of manganese dipyridoxl diphosphate (Mangafodipir, MnDPDP).
  • Blood tests — DIAGNOSTIC_TEST
    full blood count, urea and electrolytes, liver function test, CRP, biomarkers for endothelial function, storage of serum and plasma for future analyses.
  • Urine tests — DIAGNOSTIC_TEST
    Urine protein, Urine creatinine
  • Cardiovascular analysis — DIAGNOSTIC_TEST
    24 hour blood pressure, arterial stiffness

Study Details

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.

Key Dates

Start date
Nov 7, 2024
Status verified
Dec 2025
Primary completion
Nov 7, 2029
Completion
Nov 7, 2029

Study Design

Enrollment
120 participants (estimated)

Arms

  • Arm: Acute Kidney Injury
    20 patients with acute kidney injury (AKI). AKI diagnosis will be based on clinical and biochemical data reflecting KDIGO criteria.
  • Arm: 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).
  • Arm: Control Subjects
    20 age-, sex- and cardiovascular risk factor- matched control subjects will be recruited and matched to the AKI cohort
  • Arm: Vasculitis
    20 patients with a new diagnosis of vasculitis (or an existing diagnosis with relapsing disease), and kidney involvement
  • Arm: Kidney failure undergoing transplantation
    20 patients with kidney failure and will receive a kidney transplant in 1 month
  • Arm: Kidney transplant rejection
    20 patients with a biopsy proven diagnosis of transplant rejection

Primary Outcome Measure

Manganese Uptake (Ki) [ Time Frame: (baseline and follow up scan in relevant cohorts) ]

Central Contacts

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