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Trial record 32 of 34 for:    uspio

Ferumoxytol Enhanced Magnetic Resonance Angiography in Chronic Kidney Disease (FeMRA in CKD)

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ClinicalTrials.gov Identifier: NCT02997046
Recruitment Status : Recruiting
First Posted : December 19, 2016
Last Update Posted : December 22, 2016
Sponsor:
Collaborator:
NHS Greater Glasgow and Clyde
Information provided by (Responsible Party):
Sokratis Stoumpos, University of Glasgow

Brief Summary:

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 Intervention/treatment Phase
Ferric Compounds Magnetic Resonance Angiography Vascular Grafting Arteriovenous Fistula Kidney Transplantation Other: Ferumoxytol Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Primary Purpose: Diagnostic
Official Title: Use of Ferumoxytol Enhanced Magnetic Resonance Angiography for Cardiovascular Assessment in Late-stage Chronic Kidney Disease
Study Start Date : December 2016
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Ferumoxytol

Arm Intervention/treatment
Pre-transplant assessment
  • CTA abdominal and aortoiliac vasculature before transplantation
  • FeMRA abdominal and aortoiliac vasculature & CMR before transplantation
Other: Ferumoxytol
Ferumoxytol used as contrast in MRA
Other Name: Feraheme

Mapping & surveillance (for fistula)
  • US vascular mapping before fistula creation
  • 6 week US fistula arm
  • FeMRA fistula arm/central veins & CMR before fistula creation and at 6 weeks
Other: Ferumoxytol
Ferumoxytol used as contrast in MRA
Other Name: Feraheme

Mapping & surveillance (for graft)
  • US vascular mapping before graft creation
  • 6 week US graft arm
  • FeMRA fistula arm/central veins & CMR before graft creation and at 6 weeks
Other: Ferumoxytol
Ferumoxytol used as contrast in MRA
Other Name: Feraheme




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Comparison of FeMRA with standard imaging techniques in identification of anatomical predictors of vascular access outcomes. [ Time Frame: Up to 2 years ]

    Outcomes include:

    1. 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
    2. Fistula or graft complications: stenosis, thrombosis, hand ischaemia, aneurysm or pseudoaneurysm, infiltration, fistula bleeding, and infection.
    3. 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.

  2. Association between cardiac function and fistula (or graft) outcomes assessed by FeMRA. [ Time Frame: Up to 2 years ]
  3. Effect of successful fistula (or graft) creation on cardiac function assessed by FeMRA. [ Time Frame: Week 6 ]
  4. Utility of FeMRA in assessment of cardiac anatomy and function before listing for kidney transplantation. [ Time Frame: Baseline ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Contacts
Contact: Sokratis Stoumpos, Doctor +44 (0)141 330 2079 Sokratis.Stoumpos@glasgow.ac.uk

Locations
United Kingdom
NHS Greater Glasgow and Clyde Recruiting
Glasgow, United Kingdom, G12 8TA
Contact: Sokratis Stoumpos, Doctor    +44 (0)141 330 2079    Sokratis.Stoumpos@glasgow.ac.uk   
Sponsors and Collaborators
Sokratis Stoumpos
NHS Greater Glasgow and Clyde

Responsible Party: Sokratis Stoumpos, Doctor, University of Glasgow
ClinicalTrials.gov Identifier: NCT02997046     History of Changes
Other Study ID Numbers: GN16RE117
First Posted: December 19, 2016    Key Record Dates
Last Update Posted: December 22, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: No plans for sharing any data at the moment.

Keywords provided by Sokratis Stoumpos, University of Glasgow:
Ferumoxytol
MRI
fistula
graft
kidney transplant
angiography
arteriovenous

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Fistula
Arteriovenous Fistula
Urologic Diseases
Renal Insufficiency
Pathological Conditions, Anatomical
Arteriovenous Malformations
Vascular Malformations
Cardiovascular Abnormalities
Cardiovascular Diseases
Vascular Fistula
Vascular Diseases
Congenital Abnormalities
Ferrosoferric Oxide
Hematinics
Parenteral Nutrition Solutions
Pharmaceutical Solutions