Post-marketing Safety Study in Patients With Moderate Renal Insufficiency Who Receive Omniscan for Contrast-enhanced Magnetic Resonance Imaging (MRI)

NCT00908310 | Completed Phase 4 Results DMC

• 1 other identifier: GE-041-075
• Study Type: interventional
• Target: 213
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Kidney Disease; Renal Insufficiency

Keywords

CKD - Chronic Kidney Disease; GBCA - Gadolinium-based contrast agent; GFR - Glomerular Filtration Rate; MRI - Magnetic Resonance Imaging; NSF - Nephrogenic Systemic Fibrosis; Known or suspected CKD with an eGFR greater than or equal to 30mL & less than 60 mL/min/1.73m2 as measured within 30 days prior to the OMNISCAN.

Outcome Measures

Primary Outcomes (1)

• 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).

  Capture of safety information in moderate renal insufficiency patients undergoing routine contrast-enhanced MRI with administration of OMNISCAN.

  Greater than or equal to 7 days post contrast administration.

Study Arms (1)

Omniscan

OTHER

Drug: Omniscan

Interventions

Omniscan DRUG

OMNISCAN will be administered intravenously at the medical discretion of the prescribing physician.

Also known as: Gadodiamide

Omniscan

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GE Healthcare: lead
• i3 Statprobe: collaborator

Study Sites (1)

GE Healthcare

Princeton, New Jersey, 08540, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Renal Insufficiency

Interventions

gadodiamide

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

As a result of the FDA reference ID: #2954949, subject enrolment was terminated at 213 subjects. All subjects (202 subjects) who received any dose of Omniscan were followed as per protocol until study completion, withdrawal, or lost-to-follow-up.

Results Point of Contact

• Title: Debra Mansfield
• Organization: GE Healthcare

debra.mansfield@ge.com

609-514-6329

Study Officials

• Rubin Sheng, MD

  GE Healthcare

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2009
• First Posted: May 25, 2009
• Study Start: May 1, 2009
• Primary Completion: June 1, 2013
• Study Completion: September 1, 2013
• Last Updated: July 17, 2014
• Results First Posted: July 17, 2014

Record last verified: 2014-07

Locations

US (1)