Evaluation of Nephrogenic Systemic Fibrosis (NSF) in Patients With Chronic Kidney Disease Following OptiMARK Injection (SHERLOC)

Guerbet

Status: Withdrawn

Conditions: Nephrogenic Systemic Fibrosis; Renal Insufficiency

Study type: Observational

Funder types: Industry

Identifiers

NCT00811863

1177-07-868

Details and patient eligibility

About

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).

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

0 participants in 2 patient groups

1

Description:

Subjects with moderate renal insufficiency defined as an eGFR 30-60 mL/min/1.73 m2

2

Description:

Subjects with severe renal insufficiency defined as an eGFR \<30 mL/min/1.73 m2 and ESRD defined as requiring dialysis