Kidney Transplantation Clinical Trial
— FeMRA in CKDOfficial title:
Use of Ferumoxytol Enhanced Magnetic Resonance Angiography for Cardiovascular Assessment in Late-stage Chronic Kidney Disease
Verified date | February 2019 |
Source | University of Glasgow |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Conventional vascular imaging techniques are often either contra-indicated in chronic kidney
disease (CKD) patients due to their relative invasiveness, risks and cost. Computed
tomography angiography (CTA) requires radiation and nephrotoxic iodinated contrast which may
precipitate significant worsening of renal function and even prompt the need for institution
of dialysis. Magnetic resonance angiography (MRA) using gadolinium-based contrast agents has
been associated with the rare disease nephrogenic systemic fibrosis. Alternative imaging
methods also have drawbacks: for example, this frail patient group has a higher risk of
complications from conventional invasive catheter-based angiography, non-contrast-enhanced
MRA allows visualization of smaller arteries but is less accurate for larger vascular
structures, and ultrasound is often not appropriate for evaluation of the deep vessels of the
abdomen and pelvis.
Ferumoxytol is an ultrasmall superparamagnetic iron oxide particle encapsulated by a
semisynthetic carbohydrate, which was initially developed as a magnetic resonance imaging
(MRI) contrast agent in 2000. However, interest in ferumoxytol as a therapeutic agent for the
treatment of iron deficiency anaemia in the setting of CKD eclipsed its use as MRI contrast
agent. During the last decade, ferumoxytol has gained appeal as an MRI contrast agent in
patients with estimated glomerular filtration rates <30mL/min and there are reports in the
literature for its safe use and utility in both adult and pediatric patients with CKD.
Participants will be selected from those who have been referred for assessment prior to
kidney transplant or prior to vascular access creation for haemodialysis and will be divided
into three groups. The first group will include patients who will undergo a CTA of abdominal
and aortoiliac vasculature as part of their preparation for potential kidney transplantation.
The second and third groups will include patients who are having a fistula or a graft created
for dialysis, respectively. These patients are routinely having US vascular mapping to
visualise the blood vessels before a fistula or a graft is created. Additionally, patients
included in the second and third groups are routinely having surveillance scans of their
fistula or graft at 6 weeks following creation. Study participants undergoing standard
imaging tests as part of their clinical care will also have ferumoxytol-enhanced MRA (FeMRA).
Status | Completed |
Enrollment | 100 |
Est. completion date | September 1, 2018 |
Est. primary completion date | September 1, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Planned surgical creation of an autogenous upper-extremity fistula or synthetic graft. AND Current treatment with maintenance haemodialysis or anticipated treatment with maintenance haemodialysis within 6 months after planned fistula or graft creation surgery. OR Planned imaging of abdominopelvic vasculature as part of pre-transplant assessment. 2. Anticipated ability to comply with study procedures. 3. Ability to provide informed consent. Exclusion Criteria: 1. Life expectancy =6 months. 2. Frail, elderly patients with multiple or serious co-morbidities (doctor's discretion). 3. Pregnancy, lactation or women of child-bearing potential not willing to use effective contraception for the duration of the study. 4. Standard contra-indications to MRI and severe claustrophobia. 5. History of allergic reaction to any intravenous iron product, known hypersensitivity to excipients, asthma, eczema, atopy, patients with immune or inflammatory conditions (e.g. systemic lupus, rheumatoid arthritis), any conditions associated with iron overload (e.g. haemochromatosis, chronic liver disease, or blood disorders requiring frequent blood transfusions), and known history of drug allergy. 6. Any other reason considered by a study physician to make subject inappropriate for inclusion. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | NHS Greater Glasgow and Clyde | Glasgow |
Lead Sponsor | Collaborator |
---|---|
Sokratis Stoumpos | NHS Greater Glasgow and Clyde |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Comparison of FeMRA with standard imaging techniques in assessment of vascular anatomy. | Multiple cross sections of various vascular beds obtained with currently used imaging techniques will be compared with matched sections obtained with FeMRA in a blinded fashion. The emphasis is generally on imaging quality and diagnostic accuracy on identification of clinically significant anatomic characteristics or lesions. | Baseline and week 6 | |
Secondary | Comparison of FeMRA with standard imaging techniques in identification of anatomical predictors of vascular access outcomes. | Outcomes include: Sonographic anatomical fistula maturation at 6 weeks after creation. Criteria of sonographic AVF maturation include: AVF lumen diameter >4mm and AVF blood flow >500mL/min Fistula or graft complications: stenosis, thrombosis, hand ischaemia, aneurysm or pseudoaneurysm, infiltration, fistula bleeding, and infection. Fistula or graft procedures: surgical revision, angioplasty, stent placement, thrombolysis or thrombectomy, ligation of accessory veins, superficialisation of vein, transposition of vein, central venous catheter use, and placement of new arteriovenous access. |
Up to 2 years | |
Secondary | Association between cardiac function and fistula (or graft) outcomes assessed by FeMRA. | Up to 2 years | ||
Secondary | Effect of successful fistula (or graft) creation on cardiac function assessed by FeMRA. | Week 6 | ||
Secondary | Utility of FeMRA in assessment of cardiac anatomy and function before listing for kidney transplantation. | Baseline |
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