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MEMRI and Kidney Disease

View on ClinicalTrials.gov ↗

At a glance

What the study gets you: Health checks and monitoring — no treatment given
Type of study: Observational (no treatment given)
Time in hospital: In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention: MRI (diagnostic test), Blood tests (diagnostic test), Urine tests (diagnostic test), Cardiovascular analysis (diagnostic test)
How long the study runs: Study runs about 60 months (dates as stated)
About the drug or intervention: 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
Patient visit burden: Not specified by the sponsor

Type of study: Observing health over time
Ages: 18 Years and over
Who: All
Number of participants: 120
Started: 2024-11-07
Last checked: 2025-12

Plain English Summary

What is this study?

• Testing a new treatment for acute kidney injury
• Clinical study - 120 participants
• Acute kidney injury (AKI) is common and costly

Who can take part?

• Ages 18 Years and over
• Diagnosed with acute kidney injury

Where?

• Edinburgh - NHS Lothian

This is a simplified summary. Always discuss with your doctor before making any decisions.

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.

Acute Kidney InjuryKidney TransplantVasculitisChronic Kidney Disease(CKD)

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What we know so far

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

Age: 18 Years and over
Who can join: All genders

Biomarkers mentioned

by a negativeeGFR

What the study is looking for

✓All subjects to be entered must:
✓Be able to provide written agreement to take part 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...
✓Additionally, cohort specific inclusion criteria are as follows:
✓Cohort 1; Acute kidney injury-

Who cannot take part

✗The following criteria apply to all patients:
✗Unable to give agreement to take part.
✗Have any contraindications to standard MRI safety criteria, including implanted devices.
✗Subjects under the age of 18 years old.
✗Pregnancy/positive pregnancy test.

See the full criteria

Inclusion Criteria: 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. Exclusion Criteria: The following criteria apply to all patients: 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. 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 immunosuppression.

Where Is This Study? (1 UK site)

NHS Lothian

Edinburgh, United Kingdom

Recruiting

Site contact (verified)

Hannah Preston, MBCHb447889742171 v1hprest@ed.ac.uk

Neeraj Dhaun, MBCHbbean.dhaun@ed.ac.uk

How to Get in Touch

Hannah Preston, MBCHb

Sponsor contact

CONTACT

447889742171 v1hprest@ed.ac.uk

Neeraj Dhaun

Sponsor contact

CONTACT

bean.dhaun@ed.ac.uk

Data sourced from ClinicalTrials.gov · Last verified: 2025-12