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

Study Overview
=================
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.

Official Title
-----------------
A Post-marketing Safety Study in Patients With Moderate Renal Insufficiency Who Receive OMNISCAN (Gadodiamide Injection) for Contrast-enhanced Magnetic Resonance Imaging.

Conditions
-----------------
Chronic Kidney Disease, Renal Insufficiency

Intervention / Treatment
-----------------
* Drug: Omniscan


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Omniscan<br> | Drug: Omniscan<br>* OMNISCAN will be administered intravenously at the medical discretion of the prescribing physician.<br>* Other names: Gadodiamide;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
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.