Manganese-Enhanced Magnetic Resonance Imaging (MEMRI) in Patients with Kidney Disease

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
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). 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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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):

• 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.

Locations
Other Locations
United Kingdom
NHS Lothian
RECRUITING
Edinburgh
Contact Information
Primary
Hannah Preston, MBCHb
v1hprest@ed.ac.uk
447889742171
Backup
Neeraj Dhaun
bean.dhaun@ed.ac.uk
Time Frame
Start Date: 2024-11-07
Estimated Completion Date: 2029-11-07
Participants
Target number of participants: 120
Treatments
Acute Kidney Injury
20 patients with acute kidney injury (AKI). AKI diagnosis will be based on clinical and biochemical data reflecting KDIGO criteria.
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).
Control Subjects
20 age-, sex- and cardiovascular risk factor- matched control subjects will be recruited and matched to the AKI cohort
Vasculitis
20 patients with a new diagnosis of vasculitis (or an existing diagnosis with relapsing disease), and kidney involvement
Kidney failure undergoing transplantation
20 patients with kidney failure and will receive a kidney transplant in 1 month
Kidney transplant rejection
20 patients with a biopsy proven diagnosis of transplant rejection
Related Therapeutic Areas
Sponsors
Collaborators: NHS Lothian
Leads: University of Edinburgh

This content was sourced from clinicaltrials.gov