A Safety & Efficacy Clinical Study to Evaluate the Narrowing of the Renal Arteries While Using Gadodiamide

NCT00209391 | Completed Phase 3

• 1 other identifier: SOV301
• Study Type: interventional
• Target: 395
• Locations: 1 country
• Sites: 1

Brief Summary

Magnetic Resonance Angiography (MRA) is an examination similar to Magnetic Resonance Imaging (MRI) which uses a magnetic field and a contrast medium when needed to visualize blood flow in the arterial vessels throughout the body. Gadodiamide, a contrast medium, is already approved and is used to image blood vessels by directly injecting it into the vein, but this procedure has not been formally tested to image the renal artery vessels using MR. The study is designed to determine the presence or absence of a relevant stenosis (ie greater than/equal to 50%) or occlusion in renal arteries. Intra-arterial Digital Subtraction Angiography will be used as the standard of truth.

Conditions

Renal Artery Stenosis

Keywords

Renal Artery Stenosis; Occlusion; Diagnostic Imaging; Omniscan; Magnetic Resonance Angiography; Contrast Media

Outcome Measures

Primary Outcomes (1)

• Subject level efficacy of CE-MRA in detecting stenosis (50% occlusion) of major renal arteries. IA-DSA is the truth standard.

  72 hours

Secondary Outcomes (1)

• Subject and vessel level efficacy comparison of CE-MRA and TOF-MRA in detecting stenosis, accessing arteries and diagnosis; Efficacy of CE-MRA and TOF-MAR combined; Clinical utility; Safety

  72 hours

Study Arms (1)

Gadodiamide Injection

EXPERIMENTAL

All subjects will receive a single intravenous bolus injection via a power injector of Omniscan (Gadodiamide injection) at a dose of 0.1 mmol/kg.

Drug: Gadodiamide Injection

Interventions

Gadodiamide Injection DRUG

Also known as: Omniscan

Gadodiamide Injection

Eligibility Criteria

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

You may qualify if:

• Study Subjects must be adults with confirmed or suspected Renal Artery stenosis.
• The subject must have been referred for Digital Subtraction Angiography.

You may not qualify if:

• The subject has a known hypersensitivity to either conventional X-ray or gadolinium-based MR contrast media including, but not restricted to, the investigational product.
• The subject is lactating.
• The subject is pregnant as defined by a serum or urine β-HCG pregnancy test obtained within 24 hours before investigational product administration.
• The subject has received or is scheduled to receive MRI contrast medium within 24 h prior to or less than 24 hours after the investigational product administration.
• The subject has received or is scheduled to receive X-ray contrast medium within 7 days prior to or less than 24 hours after administration of investigational product.
• The subject has received an investigational product within 30 days prior to or will receive an investigational product less than 24 hours after investigational product administration.
• The subject has an active, serious, life-threatening disease with a life expectancy of less than 6 months.
• The subject has had a percutaneous transluminal angioplasty (PTA) in the renal region performed within 4 weeks prior to investigational product administration.
• The subject has a stent in the renal arteries.
• The subject has had a kidney transplantation.
• The subject has a serum creatinine value of \>3.5 mg/dL (309.4 µmol/L).
• The subject has previously been included in this study.
• The subject has a contra-indication for MRI according to accepted clinical guidelines.

Sponsors & Collaborators

• GE Healthcare: lead

Study Sites (1)

Amersham Buchler GmbH & Co. KG

Ismaning, Germany

Location

MeSH Terms

Conditions

Renal Artery Obstruction; Bites and Stings

Interventions

gadodiamide

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Poisoning; Chemically-Induced Disorders; Wounds and Injuries

Study Officials

• Michael Karl, PhD

  GE Healthcare

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 21, 2005
• Study Start: September 1, 2003
• Primary Completion: August 1, 2005
• Study Completion: August 1, 2005
• Last Updated: April 25, 2019

Record last verified: 2019-04

Locations

DE (1)