Nephrotoxicity of Iopamidol Versus Iodixanol in High-Risk Patients

Chronic Renal Disease Clinical Trial

— NEIHR  

Official title:

Nephrotoxicity of Iopamidol Versus Iodixanol in High-Risk Patients:A Multicentre Randomized Double-Blind Trail of Contrast-Induced Nephropathy in Patients With Chronic Kidney Disease

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01402219
• Other study ID #: 2008A030201002
• Status: Terminated
• Phase: Phase 4
• First received: July 25, 2011
• Last updated: August 27, 2013
• Start date: November 2008
• Est. completion date: May 2013

Study information

• Verified date: August 2013
• Source: Guangdong General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the incidence of contrast-induced nephropathy (CIN) following the administration of iopamidol-370 (Iopamiro-370) and iodixanol-320 (Visipaque 320) in patients with chronic kidney disease undergoing coronary angiography.

Description:

To compare the incidence of contrast-induced nephropathy (CIN)(an absolute SCr increase 0.5 mg/dL from baseline) following the administration of iopamidol-370 (Iopamiro-370) and iodixanol-320 (Visipaque 320) in patients with chronic kidney disease (serum creatinine level more than 1.5 mg/dL for men and more than 1.3 mg/dL for women or preprocedural estimated glomerular filtration rate(eGFR):15-60 mL/min/1.73 m2) undergoing coronary angiography.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 204
• Est. completion date: May 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Provides written Informed Consent and is willing to comply with protocol requirements

• Is =18 years of age

• Has a documented predose serum creatinine level of =1.5 mg/dL for men and = 1.3 mg/dL for women or predose estimated glomerular ?ltration rate (eGFR) of > 15 and = 60 mL/min/1.73 m2, calculated via the MDRD formula from a SCr obtained within 72 hours of enrollment into the study;

• Is referred for cardiac angiography with or without PCI;

• If at the discretion of the Investigator is receiving or will be receiving a prophylactic medication for renal function, the medication is one that is permitted by this protocol (N acetylcysteine, 1200 mg twice daily on the day before and on the day of the cardiac angiography procedure);

• Undergoes or is scheduled to undergo pre, peri, or post procedure hydration permitted by this protocol, i.e.:

• 154 mEq/L sodium bicarbonate solution, administered intravenously at 3 mL/kg/hr for 1 hour before cardiac angiography, followed by an infusion of 1 mL/kg/hr during and out to 6 hours after cardiac angiography, or 0.9% normal saline administered intravenously at 1 mL/kg/hr for 8-12 hours before cardiac angiography, followed by an infusion of 1 mL/kg/hr during and out to 24 hours after cardiac angiography,for the patients with left ventricular ejection fraction <35% or congestive heart failure (class III in accordance with the classification of the New York Heart Association (NYHA), the rate of infusion decreases to half of the above ordinary rate.

Exclusion Criteria:

• Is a pregnant or lactating female. Exclude the possibility of pregnancy: by laboratory testing on-site at the institution (measurement of serum or urine ßHCG) within 24 hours prior to the start of investigational product administration by history (e.g., tubal ligation or hysterectomy, post menopausal with a minimum 1 year without menses)

• Has a history of hypersensitivity to iodine-containing compounds;

• Has unstable renal function (i.e., acute worsening of renal function, as determined by the Investigator, that has been observed in the 7 days prior to enrollment) and/or is in acute renal failure;

• Has end-stage renal disease (i.e., eGFR <15 mL/min/1.73 m2)

• Has severe congestive heart failure (class IV in accordance with the classification of the New York Heart Association (NYHA) ;

• Has uncontrolled diabetes, as determined by the Investigator;

• Has received an iodinated contrast agent within 7 days prior to the administration of the study agent or is scheduled to receive an iodinated contrast agent within 72 hours after administration of the study agent; intake of nephrotoxic drugs within the previous seven days Prior to, during or post the cardiac angiography, is receiving or will be receiving a prophylactic medication to prevent acute kidney injury that is not permitted by this protocol (e.g., theophylline, fenoldopam, etc.);

• Is planned to undergo major surgery (e.g. CABG, valve surgery, etc.) within 48-72 hours after contrast administration;

• Is planned to receive an intravenous diuretic or mannitol as prophylaxis to prevent acute renal injury (Note: chronic administration is allowed);

• Is hemodynamically unstable within 48 hours pre-contrast administration defined as a systolic blood pressure < 90 mmHg or requires pressor or intra-aortic balloon support

Study Design

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

Related Conditions & MeSH terms

• Chronic Renal Disease
• Kidney Failure, Chronic
• Renal Insufficiency, Chronic

Intervention

Drug:
• Iopamidol injection 76%
Iopamiro-370 (Iopamidol injection 76%) is provided in single dose bottles/vials, ready to use, aqueous, nonpyrogenic, colorless to pale yellow sterile solution
• iodixanol
Visipaque 320 (iodixanol) injection is provided in bottles/flexible containers, ready to use sterile, pyrogen-free colorless to pale yellow solution

Locations

Country	Name	City	State
China	Guangdong Cardiovascular Institute,Guangdong General Hospital	Guangzhou	Guangdong

Sponsors (5)

Lead Sponsor	Collaborator
Guangdong General Hospital	First Affiliated Hospital, Sun Yat-Sen University, Guangzhou General Hospital of Guangzhou Military Command, Nanfang Hospital of Southern Medical University, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	contrast-induced nephropathy	Contrast-Induced Nephropathy was defined as an increase in serum creatinine of more than 0.5 mg/dl or 25% from the baseline within 48-72 h of contrast exposure	48-72 h	Yes
Secondary	A relative increase in serum creatinine	A relative increase in serum creatinine was defined as more than 25% increase in serum creatinine within 48-72 h of contrast exposure.	48-72 h	Yes
Secondary	A relative increase in estimated glomerular ?ltration rate (eGFR)	A relative increase in eGFR was defined as more than 25% increase in eGFR within 48-72 h of contrast exposure	48-72 h	Yes
Secondary	An absolute increase in serum creatinine	An absolute increase in serum creatinine within 48-72 h of contrast exposure	48-72 h	Yes
Secondary	Major adverse clinical events	Major adverse clinical events: death, requiring renal replacement therapy, 2nd myocardial infarction,target revascularization,acute heart failure, mechanical ventilation,2nd angina,tachyarrhythmia,hypotension,intra-aortic balloon pump and stroke	1 month	Yes
Secondary	Major adverse clinical events	Major adverse clinical events: death, requiring renal replacement therapy, acute myocardial infarction,target revascularization,acute heart failure, mechanical ventilation,2nd angina,tachyarrhythmia,hypotension,intra-aortic balloon pump and stroke	1 year	Yes
Secondary	An significant increase in serum creatinine	An significant increase in serum creatinine was defined as an increase in serum creatinine of more than 1.0 mg/dl from the baseline within 48-72 h of contrast exposure	48-72 h	Yes
Secondary	Contrast-Induced Acute Kidney Injury	Contrast-Induced Acute Kidney Injury was defined as an increase in serum creatinine concentration of more than 0.3 mg/dL from the baseline value at 48 hours after administration of the contrast exposure or the need for dialysis	48 h	Yes