A Safety Comparison of Iopromide and Iodixanol in Renal Impaired Patients

Kidney Failure, Chronic Clinical Trial

— DIRECT  

Official title:

A Randomized, Double-blinded Comparison of Iopromide and Iodixanol in Renally Impaired Patients Undergoing Cardiac Catheterization

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00926562
• Other study ID #: 14147
• Status: Completed
• Phase: Phase 4
• First received: June 19, 2009
• Last updated: June 24, 2011
• Start date: February 2009
• Est. completion date: May 2011

Study information

• Verified date: June 2011
• Source: Chinese PLA General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The investigators intend to find out which contrast agent has less kidney toxicity in renal impaired patients undergoing cardiac angiography or percutaneous coronary intervention (PCI).

Description:

In the diagnosis and treatment of coronary heart disease, patients should undergo cardiac angiography or percutaneous coronary intervention (PCI). In those procedures, the investigators should use the contrast media, and it may cause kidney toxicity especially in the patients with chronic renal insufficiency.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 592
• Est. completion date: May 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years old or older

• Plan to undergo Cardiac Catheterization

• Signed ICF

• eGFR: 30~59 mL/min/1.73m2

Exclusion Criteria:

• Pregnancy

• Under dialysis

• Conditions interfering with Cardiac Catheterization

• Participation in other trials

• Allergic to X-ray contrast media

• Administration of any investigational drug within the previous 30 days

• Intra-arterial or intravenous administration of iodinated contrast medium from 7 days before to 72 hours after the administration of study drug

• Left ventricular ejection fraction (LVEF) less than 30% by ultrasound examination

• Intake of any nephrotoxic medications 24 hours before or after the administration of study drug

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Kidney Failure, Chronic
• Renal Insufficiency

Intervention

Drug:
• Iopromide (Ultravist)
Iopromide (contrast agent), 370 mgl/ml, an nonionic, monomeric, LOCM
• Iodixanol (Visipaque)
Iodixanol (contrast agent) 320 mgl/ml, a nonionic, dimeric, IOCM

Locations

Country	Name	City	State
China	Beijing CHAO-YANG Hospital	Beijing	Beijing
China	Beijing Hospital	Beijing	Beijing
China	Beijing Shi Jing Shan Hospital	Beijing	Beijing
China	Chinese PLA general hospital	Beijing	Beijing
China	General Hospital of Armed Police Forces	Beijing	Beijing
China	Peking University Third Hospital	Beijing	Beijing
China	China-Japan Union Hospital of Jilin University	Changchun	Jilin
China	The First Hospital of Jilin University	Changchun	Jinlin
China	The Second Hospital of Xiangya	Changsha	Hunan
China	Sir Run Run Shaw Hospital affiliated to Zhejiang	Hangzhou	Zhejiang
China	The Second Hospital Affiliated to Zhejiang University	Hangzhou	Zhejiang
China	Changhai Hospital affiliated to the second millitary medical university	Shanghai	Shanghai
China	Renji Hospital affiliated to Shanghai Jiao Tong University	Shanghai	Shanghai
China	Shanghai First People's Hospital	Shanghai	Shanghai
China	Teda International Cardiovascular Hospital	Tianjin	Tianjin
China	Tianjin Chest Hospital	Tianjin	Tianjin
China	Wuhan Asia Heart Hospital	Wuhan	Hubei
China	Henan Provincial People's Hospital	Zhengzhou	Henan
China	The First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Chinese PLA General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients exhibiting a relative increase in serum creatinine >= 50% from baseline.		day 3 postreatment	Yes
Secondary	Proportion of patients developing acute renal failure.		day 30 postreatment	Yes
Secondary	Incidence of a postdose SCr increase ?25%, a postdose SCr increase ?1mg/dL, a postdose SCr increase ?0.5mg/dL, a postdose eGFR decrease ?25%		days 3	Yes