Nephrotoxicity of Iopamidol Versus Iodixanol in High-Risk Patients

NCT01402219 | Terminated Phase 4 DMC

• 1 other identifier: 2008A030201002
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Renal Disease

Keywords

contrast-induced nephropathy; contrast medium; creatinine clearance; coronary angiography; chronic kidney disease

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (7)

• A relative increase in serum creatinine

  48-72 h

• A relative increase in estimated glomerular filtration rate (eGFR)

  48-72 h

• An absolute increase in serum creatinine

  48-72 h

• Major adverse clinical events

  1 month

• Major adverse clinical events

  1 year

Study Arms (2)

Iopamiro-370

ACTIVE COMPARATOR

Drug: Iopamidol injection 76%

Visipaque 320

ACTIVE COMPARATOR

Drug: iodixanol

Interventions

Iopamidol injection 76% DRUG

Iopamiro-370 (Iopamidol injection 76%) is provided in single dose bottles/vials, ready to use, aqueous, nonpyrogenic, colorless to pale yellow sterile solution

Iopamiro-370

iodixanol DRUG

Visipaque 320 (iodixanol) injection is provided in bottles/flexible containers, ready to use sterile, pyrogen-free colorless to pale yellow solution

Visipaque 320

Eligibility Criteria

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

You may qualify if:

• 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.:
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Guangdong Provincial People's Hospital: lead
• First Affiliated Hospital, Sun Yat-Sen University: collaborator
• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: collaborator
• Nanfang Hospital, Southern Medical University: collaborator
• Guangzhou General Hospital of Guangzhou Military Command: collaborator

Study Sites (1)

Guangdong Cardiovascular Institute,Guangdong General Hospital

Guangzhou, Guangdong, 510100, China

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

iodixanol

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jiyan Chen, MD

  chen-jiyan@163.com

  STUDY CHAIR

• Yingling Zhou, MD

  Guangdong Cardiovascular Institute,Guangdong General Hospital

  STUDY DIRECTOR

• Yong Liu, MD

  liuyongyisheng@126.com

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: July 25, 2011
• First Posted: July 26, 2011
• Study Start: November 1, 2008
• Primary Completion: February 1, 2013
• Study Completion: May 1, 2013
• Last Updated: August 28, 2013

Record last verified: 2013-08

Locations

CN (1)