Renal Safety of Iopamidol Versus Iodixanol During Coronary Angiography in Diabetic Patients

NCT00782639 | Terminated Phase 4 Results

• 1 other identifier: IOP114
• Study Type: interventional
• Target: 23
• 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 moderate-to-severe chronic kidney disease and diabetes mellitus undergoing cardiac angiography.

Conditions

Chronic Renal Impairment; Diabetes Mellitus

Outcome Measures

Primary Outcomes (2)

• The Number of Participants With Contrast-induced Nephropathy (CIN)

  The number of participants who presented with CIN (defined as an increase in Serum Creatinine (SCr) from baseline greater than or equal to 0.5 mg/dL following the administration of iopamidol-370 or iodixanol 320 while undergoing cardiac angiography). Since CIN is a prospectively-defined outcome measure of the trial, patients experiencing CIN were not reported as having an adverse event.

  48 to 72 hours After Injection of Contrast Media

• Baseline and Change From Baseline Measurements for the One Participant With Contrast-Induced Nephropathy (CIN) at the 48 to 72 Hours After Injection of Contrast Media Visit

  Only 1 participant presented with incidence of CIN (change from baseline greater than or equal to 0.5 mg/dL) following the administration of iopamidol-370 while undergoing cardiac angiography. The participant's measurements at baseline and at 48 to 72 hours after the injection of contrast agent, as well as the difference between the two, are displayed here. Since CIN is a prospectively-defined outcome measure of the trial, patients experiencing CIN were not reported as having an adverse event.

  Baseline (just prior to injection of contrast media) and 48 to 72 hours after injection of contrast media

Secondary Outcomes (4)

• The Number of Participants With a >=25% Decrease in Estimated Glomerular Filtration Rate (eGFR)

  Baseline (just prior to injection of contrast media) and 48 to 72 hours after injection of contrast media

• The Number of Participants With a >=25% Increase in Serum Creatinine (SCr)

  Baseline (just prior to injection of contrast media) and 48 to 72 hours after injection of contrast media

• Number of Participants Requiring Dialysis

  48 to 72 hours after injection of contrast media

• Number of Participants Who Died From Acute Renal Failure

  Any timepoint (Screening [up to 72 hours prior to injection of contrast media], Baseline [just before injection], or 48 to 72 hours or 7 days after injection)

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

Also known as: Isovue

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 eGFR of \>15 and ≤50 mL/min/1.73 m2, calculated via the Modification of Diet in Renal Disease (MDRD) formula from a SCr obtained within 72 hours of enrollment into the study;
• Diagnosed as having diabetes mellitus (Type 1 or Type 2) treated with insulin or oral hypoglycemic agents for at least 6 months
• Is referred for cardiac angiography with or without percutaneous coronary intervention;
• 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 154 mEq/L sodium chloride solution (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 8-12 hours after cardiac angiography

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 beta human chorionic gonadotropin) 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 stage 5 chronic kidney disease or end-stage renal disease (i.e., estimated glomerular filtration rate \[eGFR\] \<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;
• Is receiving cyclo-oxygenase-2 inhibitors, nonsteroidal anti-inflammatory drugs (with exception of low dose aspirin \[≤325 mg per day\]), aminoglycosides, or any other drugs that carry a significant risk of nephrotoxicity (in the opinion of the Investigator) during the time period beginning within 72 hours prior to contrast administration and up to 72 hours postdose;
• 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.);
• During cardiac angiography, is going to receive provocative pharmacological agents such as adenosine or dipyridamole;
• Is planned to undergo major surgery (e.g. coronary artery bypass graft, 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;
• Has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study and/or postdose follow-up examinations;
• Is determined by the Investigator that the patient is clinically unsuitable for the study Note: Changes in diuretics, angiotensin-converting enzyme inhibitors, or angiotensin receptor blockers doses within 72 hours prior to and up to 72 hours post contrast administration should be avoided unless clinically necessary for the subject's underlying medical condition.

Sponsors & Collaborators

• Bracco Diagnostics, Inc: lead

Study Sites (1)

Bracco Diagnostics Inc.

Princeton, New Jersey, 08540, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Diabetes Mellitus

Interventions

Iopamidol; 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; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Triiodobenzoic Acids; Iodobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Limitations and Caveats

This study was terminated early due to low enrollment. Only 1 patient in the Iopamiro-370 group had CIN (per all 3 definitions \[first 3 secondary outcome measures\] of CIN); therefore, no formal analyses were performed.

Results Point of Contact

• Title: Usha Halemane
• Organization: Bracco Diagnostics, Inc

usha.halemane@diag.bracco.com

609-514-2578

Study Officials

• Alberto Spinazzi, M.D.

  Bracco Diagnostics

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

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: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2008
• First Posted: October 31, 2008
• Study Start: March 1, 2009
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: January 26, 2012
• Results First Posted: September 1, 2011

Record last verified: 2012-01

Locations

US (1)