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

This study has been terminated.
(There were few eligible subjects from other centers.)
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 General Hospital
ClinicalTrials.gov Identifier:
NCT01402219
First received: July 25, 2011
Last updated: August 27, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention Phase
Chronic Renal Disease
Drug: Iopamidol injection 76%
Drug: iodixanol
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Guangdong General Hospital:

Primary Outcome Measures:
  • contrast-induced nephropathy [ Time Frame: 48-72 h ] [ Designated as safety issue: Yes ]
    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


Secondary Outcome Measures:
  • A relative increase in serum creatinine [ Time Frame: 48-72 h ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    An absolute increase in serum creatinine within 48-72 h of contrast exposure

  • Major adverse clinical events [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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


Enrollment: 204
Study Start Date: November 2008
Study Completion Date: May 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Iopamiro-370 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
Other Name: Iopamidol injection 76%
Active Comparator: Visipaque 320 Drug: iodixanol
Visipaque 320 (iodixanol) injection is provided in bottles/flexible containers, ready to use sterile, pyrogen-free colorless to pale yellow solution
Other Name: iodixanol

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01402219

Locations
China, Guangdong
Guangdong Cardiovascular Institute,Guangdong General Hospital
Guangzhou, Guangdong, China, 510100
Sponsors and Collaborators
Guangdong General Hospital
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
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
  More Information

No publications provided

Responsible Party: Jiyan Chen, MD, Guangdong General Hospital
ClinicalTrials.gov Identifier: NCT01402219     History of Changes
Other Study ID Numbers: 2008A030201002
Study First Received: July 25, 2011
Last Updated: August 27, 2013
Health Authority: China: Ethics Committee

Keywords provided by Guangdong General Hospital:
contrast-induced nephropathy
contrast medium
creatinine clearance
coronary angiography
chronic kidney disease

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Renal Insufficiency
Urologic Diseases
Iodixanol
Iopamidol
Contrast Media
Diagnostic Uses of Chemicals
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 25, 2014