Kidney Damage in Patients With Moderate Fall in eGFR

NCT01136876 | Completed Phase 4 Results

• 1 other identifier: IOP-117
• Study Type: interventional
• Target: 57
• Locations: 2 countries
• Sites: 4

Brief Summary

To compare Iopamidol injection 370 and Iodixanol 320 in evaluating Neutrophil Gelatinase-Associated Lipocalin (NGAL) in patients with moderate fall in eGFR

Conditions

Coronary Artery Stenosis

Outcome Measures

Primary Outcomes (1)

• Impact on the Trajectory of Serum and Urinary Neutrophil Gelatinase-associated Lipocalin (NGAL) Following Administration

  Mean change from baseline values for serum NGAL at 2,4,6,24,48, and 72 hours, and urine NGAL at 2,4,6,24, and 48 hours following the administration of contrast media.

  Baseline and 2, 4, 6, 24, 48,and 72 hours post-dose

Study Arms (2)

Iopamidol

ACTIVE COMPARATOR

Non-ionic low-osmolar iodinated contrast media

Drug: Iopamidol

Iodixanol

ACTIVE COMPARATOR

Non-ionic iso-osmolar iodinated contrast media comparator

Drug: Iodixanol-320

Interventions

Iopamidol DRUG

Iopamidol 370, one time administration for percutaneous coronary intervention

Also known as: Isovue-370

Iopamidol

Iodixanol-320 DRUG

Iodixanol-320 single administration for percutaneous coronary intervention procedure

Also known as: Visipaque 320

Iodixanol

Eligibility Criteria

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

You may qualify if:

• At least 18 years of age and provides informed consent
• Scheduled to undergo percutaneous coronary intervention
• Documented pre-dose Estimated glomerular filtration rate (eGFR) of greater than or equal to 30 mL/min/1.73 m squared and less than or equal to 59 mL/min/1.73 m squared

You may not qualify if:

• Pregnant or lactating females
• Severe congestive heart failure
• History of hyperthyroidism;
• Unstable renal function
• Emergency PCI
• History of hypersensitivity to iodinated contrast agents
• Receiving diuretics to prevent acute renal injury

Sponsors & Collaborators

• Bracco Diagnostics, Inc: lead

Study Sites (4)

Research Cooperative, St. John's Hospital

Springfield, Illinois, 62701, United States

Location

UMDNJ - RWJ Medical School

New Brunswick, New Jersey, 08901, United States

Location

The Institute for Clinical Research at Holy Name Medical Center

Teaneck, New Jersey, 07666, United States

Location

Montreal Heart Institute

Montreal, Quebec, H1T 1C8, Canada

Location

MeSH Terms

Conditions

Coronary Stenosis

Interventions

Iopamidol; iodixanol

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Triiodobenzoic Acids; Iodobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Results Point of Contact

• Title: Maria Luigia Storto, M.D.
• Organization: Bracco Diagnostics Inc.

MariaLuigia.Storto@diag.bracco.com

609-514-2262

Study Officials

• Maria Luigia Storto, MD

  Bracco Diagnostics, Inc

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2010
• First Posted: June 4, 2010
• Study Start: November 1, 2010
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: November 4, 2020
• Results First Posted: December 30, 2013

Record last verified: 2013-09

Locations

US (3); CA (1)