Post-Marketing Safety Study in Patients with Moderate Renal Insufficiency who receive Omniscan for Contrast-Enhanced Magnetic Resonance Imaging (MRI)
- Registration Number
- CTRI/2009/091/000747
- Lead Sponsor
- GE Healthcare Pvt Ltd.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 600
The subject has been referred for a clinically indicated MRI examination with a gadolinium-based contrast agent.
The subject is > 18 years of age at time of study entry.
The subject has known or suspected chronic kidney disease with an eGFR greater than or equal to 30mL and <60 mL/min/1.73 m2 as measured within 30 days prior to the planned index OMNISCAN administration(GFR will be
estimated all subjects using the MDRD GFR extended version calculator).
The subject agrees to be contacted for follow-up for 24 months.
Patients with known or suspected NSF based on biopsy confirmation or the onset of signs and symptoms of NSF lasting at least 7 days as follows:
1. skin - swelling, hardening and tightening; reddened or darkened patches; burning or itching;
2. eyes - yellow raised spots on whites of eyes; or
3. bones and muscle - stiffness in joints; difficulty in moving or straightening of arms, hands, legs or feet; bone pain especially in hips and ribs or muscle weakness.
Patients allergic to any GBCA.
Patients with chronic renal disease with a GFR <30 mL/min/1.73 m2 as measured within 30 days prior to the planned OMNISCAN administration.
Patients with acute renal insufficiency of any severity due to the hepato-renal syndrome or in the peri-operative liver transplantation period.
Patients that were exposed to any GBCA within a period of 12 months prior the planned index administration of Omniscan.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Development of NSF, whether or not confirmed histologicallyTimepoint: All subjects will be followed for approximately 2 years after the Omniscan administration. Time zero equals the date of Omniscan injection. <br>;To capture post-marketing safety information in patients with moderate renal insufficiency undergoing routine contrast-enhanced MRI with administration of OMNISCAN in order to assess the risk for developing nephrogenic systemic fibrosis. [ Time Frame: Time zero equals the date of Omniscan injection. All subjects will be followed for approximately 2 years after the administration of Omniscan ] [ Designated as safety issue: Yes ]<br><br>Timepoint:
- Secondary Outcome Measures
Name Time Method Development of NSF in 2 years follow up period confirmed histologicallyTimepoint: All subjects will be followed for approximately 2 years after the Omniscan administration. Time zero equals the date of Omniscan injection. <br>