A Study to Explore the Renal Safety of Visipaque Injection 320 mgI/mL in Patients With Chronic Kidney Disease

Chronic Kidney Diseases Clinical Trial

Official title:

Parallel-Group, Placebo-Controlled Randomized Study Investigating the Effect of Intravenous Iso-osmolar Iodinated Contrast Material Iodixanol (Visipaque™ Injection 320 mgI/mL) on Renal Function in Adults With Chronic Kidney Disease (CKD) Stage III or Stage IV Who Have Undergone Endovascular Aneurysm Repair (EVAR)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03119662
• Other study ID #: GE-012-106
• Secondary ID: 2016-001668-13
• Status: Terminated
• Phase: Phase 4
• Start date: February 8, 2018
• Est. completion date: October 19, 2018

Study information

• Verified date: November 2019
• Source: GE Healthcare
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This parallel-group, randomized, placebo-controlled study will examine the incidence and severity of acute kidney injury (AKI) in patients with chronic kidney disease (CKD) stage III/IV following an i.v. injection of iso-osmolar iodinated contrast material iodixanol (Visipaque™ Injection 320 mgI/mL), as compared with patients who received saline and underwent a non-enhanced CT (NECT) and duplex ultrasound (US) during their scheduled post-EVAR surveillance imaging.

Description:

GEHC has decided not to provide this detail

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: October 19, 2018
• Est. primary completion date: September 13, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Was =18 years of age at the time that written informed consent is obtained.

• Was male or is a nonpregnant, nonlactating female who is either surgically sterile or is postmenopausal. Women of childbearing potential must use adequate contraception from Screening until 30 days after the Baseline Visit and must have a negative pregnancy test at the Baseline Visit.

• Was an outpatient who has undergone successful EVAR and is scheduled for his/her next post-procedural imaging follow-up examination.

• Had previously completed one or more of his or her post-EVAR surveillance imaging examination(s) that provided evidence on stable post-EVAR status.

• Had a documented diagnosis of stage III or IV CKD and stable renal function.

• Was able to provide written informed consent.

• Was able and willing to comply with all study procedures as described in the protocol.

Exclusion Criteria:

• Was pregnant, lactating, is possibly pregnant, or is actively trying to conceive during the study period.

• Was a patient for whom an endoleak or other clinically meaningful EVAR-related complication (as judged by the investigator) has already been discovered.

• Was undergoing surveillance following a Thoracic Endovascular Repair (TEVAR).

• Had a known or suspected history of immediate or delayed hypersensitivity to iodine or any iodinated contrast medium.

• Was using metformin (e.g., Glucophage®) that cannot be discontinued for the period of 24 hours prior to the Baseline Visit and for at least 48 hours after the imaging procedure.

• Had been exposed to any intravascular iodinated contrast medium in the 7 days prior to the Baseline Visit.

• Had congestive heart failure (New York Heart Association [NYHA] Class IV) or hepatic failure/liver cirrhosis.

• Had Stage V CKD.

• Had a pre-existing requirement for renal dialysis.

• Had undergone percutaneous transluminal renal angioplasty (PTRA) within 12 months before the index EVAR procedure or is scheduled to undergo PTRA during the study period.

• Had any clinically active, serious, life-threatening disease, medical, or significant psychiatric condition; has a life expectancy of less than 6 months; or is, in the Investigator's opinion, unsuitable for participation in the study for any reason.

• Had been enrolled in another clinical study within the 30 days prior to the Screening Visit or is planned to enroll in another clinical study within the duration of this study.

• Had been previously enrolled in this study.

• Was using i.v. vasopressor or inotropic medications.

• Had used nonsteroidal anti-inflammatory drugs (NSAIDs) or any nephrotoxic medication within 48 hours of the Baseline Visit or will do so within 72 hours after the CT procedure-with the exception of acetylsalicylic acid (Aspirin) at a dose of =100 mg daily (QD).

• Had been hospitalized within 30 days prior to Screening Visit for any reason other than practical purposes for management of tests or diagnostic assessments.

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• Visipaque
100 mL iodixanol (Visipaque Injection 320 mg I/mL), followed by a 10 mL saline flush to ensure delivery of the full dose of Visipaque.
• Placebos
100 mL saline, followed by a 10 mL saline flush.

Locations

Country	Name	City	State
Belgium	UZ Leuven	Leuven
Canada	CRCHUM- CHUM Research Center	Montreal
Canada	St. Boniface General Hospital	Winnipeg
Poland	Oddzial Chirurgii Naczyniowej i Ogolnej, Wojewodzki Szpital Specjalistyczny Nr 4 w Bytomiu	Bytom
Poland	Klinika Kardiochirurgii i Chirurgii Naczyniowej, Uniwersyteckie Centrum Kliniczne	Gdansk
Poland	Klinika Chirurgii Naczyniowej i Angiologii, Samodzielny Publiczny Szpital Kliniczny nr 1	Lublin
Poland	Oddzial Chirurgii Ogolnej i Naczyn, Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego	Poznan
Spain	Hospital Clinic de Barcelona	Barcelona
Spain	Hospital Universitario Puerta del Mar	Cadiz
Spain	Hospital Universitario Son Espases	Palma
United Kingdom	St. George's Healthcare NHS Trust, St. George's Hospital	London
United Kingdom	Royal Stoke University Hospital, Radiology Department	Stoke on Trent
United States	University Hospital	Birmingham	Alabama
United States	Boston University Medical Center/Boston Medical Center	Boston	Massachusetts
United States	University of Vermont Medical Center	Burlington	Vermont
United States	University of North Carolina at Chapel Hill Clinical Translational Research Center	Chapel Hill	North Carolina
United States	UT Southwestern Medical Center	Dallas	Texas
United States	Universal Axon Clinical Research, LLC	Doral	Florida
United States	The Duluth Clinic, Ltd.	Duluth	Minnesota
United States	University of Iowa Hospitals and Clinics	Iowa City	Iowa
United States	Jacksonville Center for Clinical Research	Jacksonville	Florida
United States	Alliance Research Centers	Laguna Hills	California
United States	Central Arkansas Veteran's Healthcare System	Little Rock	Arkansas
United States	Norton Hospital	Louisville	Kentucky
United States	: Aventiv Research Inc.	Mesa	Arizona
United States	Mount Sinai West	New York	New York
United States	Rhode Island Hospital	Providence	Rhode Island
United States	University of South Florida - South Tampa Campus	Tampa	Florida
United States	Wake Forest Baptist Health	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
GE Healthcare	Syneos Health

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  Poland,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of the Incidence of Acute Kidney Injury (AKI) Stage >=1 Per Acute Kidney Injury Network (AKIN) Serum Creatinine (SCr) Criteria	AKIN Serum Creatinine Criteria for AKI- Stage 1: a SCr increase of >=0.3 mg/dL (>=26.4 µmol/L) or increase to >=150% to 200% (>=1.5- to 2.0-fold) from baseline within 48 hours. Stage 2: a SCr increase to >200% to 300% (>2.0- to 3-fold) from baseline within 48 hours. Stage 3: a SCr increase to >300% (>3.0-fold) from baseline or SCr >=4.0 mg/dL (>=354 µmol/L) with an acute increase of >=0.5 mg/dL (>=44 µmol/L) within 48 hours.	48 hours post-baseline (Follow-up 1)
Secondary	Assessment of the Incidence of Acute Kidney Injury (AKI) Stage >=2 Per Acute Kidney Injury Network (AKIN) Serum Creatinine (SCr) Criteria	AKIN Serum Creatinine Criteria for AKI- Stage 1: a SCr increase of >=0.3 mg/dL (>=26.4 µmol/L) or increase to >=150% to 200% (>=1.5- to 2.0-fold) from baseline within 48 hours. Stage 2: a SCr increase to >200% to 300% (>2.0- to 3-fold) from baseline within 48 hours. Stage 3: a SCr increase to >300% (>3.0-fold) from baseline or SCr >=4.0 mg/dL (>=354 µmol/L) with an acute increase of >=0.5 mg/dL (>=44 µmol/L) within 48 hours.	48 hours post-baseline (Follow-up 1)
Secondary	Assessment of the Incidence of Acute Kidney Injury (AKI) by Contrast Induced Nephropathy (CIN)	Standard definition of CIN: Increase in SCr of 0.5 mg/dL or more in the 24 to 72 hours after the CT scan.	48 hours post-baseline (Follow-up 1)
Secondary	Assessment of the Incidence of Acute Kidney Injury (AKI) Stage >=2 By Waikar Criteria	Waikar's definitions of AKI: Stage 1: 0.3 mg/dL increase in SCr over 24 hours or a 0.5 mg/dL increase in SCr over 48 hours. Stage 2: 0.5 mg/dL increase in SCr over 24 hours or a 1.0 mg/dL increase in SCr over 48 hours. Stage 3: 1.0 mg/dL increase in SCr over 24 hours or a 1.5 mg/dL increase in SCr over 48 hours.	48 hours post-baseline (Follow-up 1)
Secondary	All Cause Mortality and Morbidity	Mortality (all cause death) and morbidity i.e. critical events.	From Baseline to Month 6
Secondary	Blinded Independent Assessment of Image Quality/Diagnostic Confidence Using a 5-Point Scale	Blinded independent assessment of image quality/diagnostic confidence using a 5-point scale. Image quality/diagnostic confidence for all imaging studies was rated on a 5-point scale from 1 (poor) to 5 (excellent).	Month 6