Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Nephrotoxicity of Iopamidol Versus Iodixanol in High-Risk Patients (NEIHR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01402219
Recruitment Status : Terminated (There were few eligible subjects from other centers.)
First Posted : July 26, 2011
Last Update Posted : August 28, 2013
Sponsor:
Collaborators:
First Affiliated Hospital, Sun Yat-Sen University
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Nanfang Hospital of Southern Medical University
Guangzhou General Hospital of Guangzhou Military Command
Information provided by (Responsible Party):
Jiyan Chen, Guangdong Provincial People's Hospital

Tracking Information
First Submitted Date  ICMJE July 25, 2011
First Posted Date  ICMJE July 26, 2011
Last Update Posted Date August 28, 2013
Study Start Date  ICMJE November 2008
Actual Primary Completion Date February 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 15, 2012)
contrast-induced nephropathy [ Time Frame: 48-72 h ]
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
Original Primary Outcome Measures  ICMJE
 (submitted: July 25, 2011)
contrast-induced nephropathy [ Time Frame: 48-72 h ]
Contrast-Induced Nephropathy was defined as an increase in serum creatinine of more than 0.5 mg/dl from the baseline within 48-72 h of contrast exposure
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 15, 2012)
  • A relative increase in serum creatinine [ Time Frame: 48-72 h ]
    A relative increase in serum creatinine was defined as more than 25% increase in serum creatinine within 48-72 h of contrast exposure.
  • A relative increase in estimated glomerular filtration rate (eGFR) [ Time Frame: 48-72 h ]
    A relative increase in eGFR was defined as more than 25% increase in eGFR within 48-72 h of contrast exposure
  • An absolute increase in serum creatinine [ Time Frame: 48-72 h ]
    An absolute increase in serum creatinine within 48-72 h of contrast exposure
  • Major adverse clinical events [ Time Frame: 1 month ]
    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
  • Major adverse clinical events [ Time Frame: 1 year ]
    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
  • An significant increase in serum creatinine [ Time Frame: 48-72 h ]
    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
  • Contrast-Induced Acute Kidney Injury [ Time Frame: 48 h ]
    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
Original Secondary Outcome Measures  ICMJE
 (submitted: July 25, 2011)
  • A relative increase in serum creatinine [ Time Frame: 48-72 h ]
    A relative increase in serum creatinine was defined as more than 25% increase in serum creatinine within 48-72 h of contrast exposure.
  • A relative increase in eGFR [ Time Frame: 48-72 h ]
    A relative increase in eGFR was defined as more than 25% increase in eGFR within 48-72 h of contrast exposure
  • An absolute increase in serum creatinine [ Time Frame: 48-72 h ]
    An absolute increase in serum creatinine within 48-72 h of contrast exposure
  • Major adverse clinical events [ Time Frame: 1 month ]
    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
  • Major adverse clinical events [ Time Frame: 1 year ]
    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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Nephrotoxicity of Iopamidol Versus Iodixanol in High-Risk Patients
Official Title  ICMJE 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
Brief 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.
Detailed 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Diagnostic
Condition  ICMJE Chronic Renal Disease
Intervention  ICMJE
  • 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
  • Drug: iodixanol
    Visipaque 320 (iodixanol) injection is provided in bottles/flexible containers, ready to use sterile, pyrogen-free colorless to pale yellow solution
Study Arms  ICMJE
  • Active Comparator: Iopamiro-370
    Intervention: Drug: Iopamidol injection 76%
  • Active Comparator: Visipaque 320
    Intervention: Drug: iodixanol
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: August 27, 2013)
204
Original Estimated Enrollment  ICMJE
 (submitted: July 25, 2011)
300
Actual Study Completion Date  ICMJE May 2013
Actual Primary Completion Date February 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 filtration 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 βHCG) 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01402219
Other Study ID Numbers  ICMJE 2008A030201002
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jiyan Chen, Guangdong Provincial People's Hospital
Study Sponsor  ICMJE Guangdong Provincial People's Hospital
Collaborators  ICMJE
  • First Affiliated Hospital, Sun Yat-Sen University
  • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
  • Nanfang Hospital of Southern Medical University
  • Guangzhou General Hospital of Guangzhou Military Command
Investigators  ICMJE
Study Chair: Jiyan Chen, MD chen-jiyan@163.com
Study Director: Yingling Zhou, MD Guangdong Cardiovascular Institute,Guangdong General Hospital
Principal Investigator: Yong Liu, MD liuyongyisheng@126.com
PRS Account Guangdong Provincial People's Hospital
Verification Date August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP