Prospective Evaluation of the Incidence of NSF in Patients With Kidney Disease Undergoing MR

A Phase 4, Open-Label, Prospective Evaluation of the Incidence of Nephrogenic Systemic Fibrosis (NSF) in Patients With Moderate to Severe Kidney Disease Undergoing Magnetic Resonance Imaging (MRI) With Ablavar (Gadofosveset Trisodium) in Routine Clinical Practice

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01135316

Enrollment

Registered

2010-06-02

Start date

2009-10-31

Completion date

2013-09-30

Last updated

2014-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nephrogenic Systemic Fibrosis

Keywords

NSF, Ablavar, Kidney Disease, Magnetic Resonance Imaging (MRI),

Brief summary

Phase 4, open-label, two-year, prospective, multi-center, follow-up study conducted at up 15 sites in USA. Approximately 1,000 patients with moderate-to-severe CKD will be enrolled and followed for up to 24 months.

Detailed description

Phase 4, open-label, two-year, prospective, multi-center, follow-up study will be conducted in up to 15 active sites in the United States. All patients will receive 1 dose of Ablavar as part of an MRI examination in their routine clinical management. Prior to undergoing an Ablavar MRI, patients will have a baseline serum creatinine test within 24 hours prior to Ablavar administration, will sign an Informed Consent (IC) form, will undergo a limited exam for skin abnormalities, and will undergo a brief medical history assessment on the day of and prior to Ablavar administration. A standardized NSF questionnaire will be administered to the patient at 48 (+ or -12) hours, 1 month (+ or - 1 week), 3 months (+ or - 2 weeks), 6 (+ or - 1) months, and 18 (+ or - 1) months post-dose. At 12 (+ or - 1) months, and at 24 (+ or - 1) months. Patients will return to the clinic for a limited examination for skin abnormalities and formal review of signs and symptoms suggestive of NSF.

Interventions

DRUGAblavar

One dose of Ablavar will be administered for use during a contrast MRI examination

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Kidney Disease with GFR \< 60 mL/min./1.73 m\^2. Clinical Need to Receive an MRI with Contrast. Understand & Sign Informed Consent.

Exclusion criteria

History of known or suspected NSF. Has received any gadolinium based contrast agent within 12 months prior to enrollment. Has a clinically significant skin disorder which may interfere with detection of cutaneous NSF manifestations. Has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data and achieving study objectives. Is unable or unwilling to return for necessary office visits or follow up calls, and/or to be examined by a physician or undergo deep skin biopsy should the development of NSF be suspected.

Design outcomes

Primary

Measure	Time frame
Incidence of Nephrogenic Systemic Fibrosis	24 months

Secondary

Measure	Time frame
Incidence of Severe Adverse Events (SAEs) & Adverse Events (AEs)	48 hours

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026