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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT00811863
Other study ID # 1177-07-868
Secondary ID
Status Withdrawn
Phase N/A
First received December 18, 2008
Last updated August 1, 2017
Start date February 2009
Est. completion date May 17, 2012

Study information

Verified date August 2017
Source Guerbet
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The objective of this study is to prospectively monitor the incidence of adverse drug reactions, specifically NSF during routine use of gadoversetamide in a large number of patients with moderate renal insufficiency (eGFR 30-59) and severe renal insufficiency or end-stage renal disease requiring dialysis (eGFR <30).


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date May 17, 2012
Est. primary completion date May 17, 2012
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- Referred for contrast-enhanced MRI using gadoversetamide;

- Have a documented estimated glomerular filtration rate (eGFR) of <60 mL/min/1.73 m2 within the past 6 months or ESRD requiring dialysis; and

- Willing and able to provide written consent (themselves or by a legally authorized representative) and agree to abide by study requirements, including being seen by a dermatologist and undergoing a skin biopsy if NSF is suspected.

Exclusion Criteria:

- Have experienced a previous hypersensitivity reaction to a GBCA;

- Have pre-existing NSF or NSF-like symptoms; or

- Have been exposed to a GBCA within 12 months prior to the index procedure; or

- Has a medical condition or other personal situation that would prevent providing follow-up information, completing clinic visits or otherwise supplying meaningful data to meet study objectives.

Study Design


Locations

Country Name City State
United States Radiology Consultants, Inc. Youngstown Ohio

Sponsors (1)

Lead Sponsor Collaborator
Guerbet

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary The primary outcome measure will be the diagnosis of NSF based on clinical assessments and patient telephone calls through 24 months of follow-up. 1, 3, 6, 12, 18 and 24 months
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