Phase 4
N=213
Post-marketing Safety Study in Patients With Moderate Renal Insufficiency Who Receive Omniscan for Contrast-enhanced Magnetic Resonance Imaging (MRI)
Chronic Kidney Disease · Renal Insufficiency
Bottom Line
View on ClinicalTrials.gov: NCT00908310 ↗Enrolled (actual)
213
Serious AEs
3.5%
Results posted
Jul 2014
Primary outcome: Primary: Capture of 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 (NSF). — 3.96; 0.00; 0.00 percentage of subjects
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Omniscan (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- GE Healthcare
- Primary completion
- Jun 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Capture of 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 (NSF). |
3.96; 0.00; 0.00 | — |
Summary
This will be an international, multi-center, post-marketing surveillance study in patients with moderate renal insufficiency who are administered gadodiamide, Omniscan, during a MRI. Omniscan will be administered intravenously at the medical discretion of the prescribing physician.
Eligibility Criteria
Inclusion Criteria
- The subject has been referred for a clinically indicated MRI examination with a gadolinium-based contrast agent.
- 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.
- The subject agrees to be contacted for follow-up for 24 months.
Exclusion Criteria
- 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:
- skin - swelling, hardening and tightening; reddened or darkened patches; burning or itching;
- eyes - yellow raised spots on whites of eyes; or
- 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.
Data sourced from ClinicalTrials.gov (NCT00908310). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.