Ferumoxytol Enhanced Magnetic Resonance Angiography in Chronic Kidney Disease (FeMRA in CKD)
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|ClinicalTrials.gov Identifier: NCT02997046|
Recruitment Status : Completed
First Posted : December 19, 2016
Last Update Posted : February 12, 2019
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).
|Condition or disease|
|Ferric Compounds Magnetic Resonance Angiography Vascular Grafting Arteriovenous Fistula Kidney Transplantation|
Show Detailed Description
|Study Type :||Observational|
|Actual Enrollment :||100 participants|
|Official Title:||Use of Ferumoxytol Enhanced Magnetic Resonance Angiography for Cardiovascular Assessment in Late-stage Chronic Kidney Disease|
|Actual Study Start Date :||December 12, 2016|
|Actual Primary Completion Date :||September 1, 2018|
|Actual Study Completion Date :||September 1, 2018|
Mapping & surveillance (for fistula)
Mapping & surveillance (for graft)
- Comparison of FeMRA with standard imaging techniques in assessment of vascular anatomy. [ Time Frame: Baseline and week 6 ]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.
- Comparison of FeMRA with standard imaging techniques in identification of anatomical predictors of vascular access outcomes. [ Time Frame: Up to 2 years ]
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.
- Association between cardiac function and fistula (or graft) outcomes assessed by FeMRA. [ Time Frame: Up to 2 years ]
- Effect of successful fistula (or graft) creation on cardiac function assessed by FeMRA. [ Time Frame: Week 6 ]
- Utility of FeMRA in assessment of cardiac anatomy and function before listing for kidney transplantation. [ Time Frame: Baseline ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02997046
|NHS Greater Glasgow and Clyde|
|Glasgow, United Kingdom, G12 8TA|