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

NCT03119662 | Terminated Phase 4 Results DMC FDA Drug

• 2 other identifiers: GE-012-1062016-001668-13
• Study Type: interventional
• Target: 4
• Locations: 6 countries
• Sites: 29

Brief 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.

Conditions

Chronic Kidney Diseases

Keywords

Acute kidney injury (AKI); Acute kidney injury network (AKIN); Chronic kidney disease (CKD); Contrast-enhanced computed tomography (CECT); Endovascular Aneurysm Repair (EVAR); Iodixanol; Non-enhanced computed tomography (NECT); Serum creatinine (SCr)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Assessment of the Incidence of Acute Kidney Injury (AKI) Stage >=2 Per Acute Kidney Injury Network (AKIN) Serum Creatinine (SCr) Criteria

  48 hours post-baseline (Follow-up 1)

• Assessment of the Incidence of Acute Kidney Injury (AKI) by Contrast Induced Nephropathy (CIN)

  48 hours post-baseline (Follow-up 1)

• Assessment of the Incidence of Acute Kidney Injury (AKI) Stage >=2 By Waikar Criteria

  48 hours post-baseline (Follow-up 1)

• All Cause Mortality and Morbidity

  From Baseline to Month 6

• Blinded Independent Assessment of Image Quality/Diagnostic Confidence Using a 5-Point Scale

  Month 6

Study Arms (2)

Visipaque™: Contrast-Enhanced Computed Tomography (CECT)

EXPERIMENTAL

Participants received 1 intravenous injection of Visipaque™ 320 mg I/ml injection (100 mL iodixanol) and underwent computed tomography (CT) examination.

Drug: Visipaque

Saline: Non-Enhanced Computed Tomography (NECT)

PLACEBO COMPARATOR

Participants received 1 intravenous injection of saline placebo (matched to Visipaque™ 320 mg I/ml injection) and underwent computed tomography (CT) examination and supplemental non-contrast duplex ultrasonography imaging examination.

Drug: Placebos

Interventions

Visipaque DRUG

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.

Visipaque™: Contrast-Enhanced Computed Tomography (CECT)

Placebos DRUG

100 mL saline, followed by a 10 mL saline flush.

Saline: Non-Enhanced Computed Tomography (NECT)

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• GE Healthcare: lead
• Syneos Health: collaborator

Study Sites (29)

University Hospital

Birmingham, Alabama, 35233, United States

Location

: Aventiv Research Inc.

Mesa, Arizona, 85210, United States

Location

Central Arkansas Veteran's Healthcare System

Little Rock, Arkansas, 72205, United States

Location

Alliance Research Centers

Laguna Hills, California, 92653, United States

Location

Universal Axon Clinical Research, LLC

Doral, Florida, 33166, United States

Location

Jacksonville Center for Clinical Research

Jacksonville, Florida, 32216, United States

Location

University of South Florida - South Tampa Campus

Tampa, Florida, 33606, United States

Location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

Norton Hospital

Louisville, Kentucky, 40202, United States

Location

Boston University Medical Center/Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

The Duluth Clinic, Ltd.

Duluth, Minnesota, 55805, United States

Location

Mount Sinai West

New York, New York, 10019, United States

Location

University of North Carolina at Chapel Hill Clinical Translational Research Center

Chapel Hill, North Carolina, 27599, United States

Location

Wake Forest Baptist Health

Winston-Salem, North Carolina, 27157, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

University of Vermont Medical Center

Burlington, Vermont, 05401, United States

Location

UZ Leuven

Leuven, 3000, Belgium

Location

CRCHUM- CHUM Research Center

Montreal, H2X 0A9, Canada

Location

St. Boniface General Hospital

Winnipeg, R2H 2A6, Canada

Location

Oddzial Chirurgii Naczyniowej i Ogolnej, Wojewodzki Szpital Specjalistyczny Nr 4 w Bytomiu

Bytom, 41-902, Poland

Location

Klinika Kardiochirurgii i Chirurgii Naczyniowej, Uniwersyteckie Centrum Kliniczne

Gdansk, 80-952, Poland

Location

Klinika Chirurgii Naczyniowej i Angiologii, Samodzielny Publiczny Szpital Kliniczny nr 1

Lublin, 20-081, Poland

Location

Oddzial Chirurgii Ogolnej i Naczyn, Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego

Poznan, 61-848, Poland

Location

Hospital Clinic de Barcelona

Barcelona, 08036, Spain

Location

Hospital Universitario Puerta del Mar

Cadiz, 11009, Spain

Location

Hospital Universitario Son Espases

Palma, 07120, Spain

Location

St. George's Healthcare NHS Trust, St. George's Hospital

London, SW17 0QT, United Kingdom

Location

Royal Stoke University Hospital, Radiology Department

Stoke-on-Trent, ST4 6QG, United Kingdom

Location

Related Publications (1)

• Solomon R. PRESERVE: The End or the Beginning of a New Era in Prevention of Contrast-Associated Acute Kidney Injury? Am J Kidney Dis. 2018 Sep;72(3):322-324. doi: 10.1053/j.ajkd.2018.03.013. Epub 2018 May 8. No abstract available.

  PMID: 29751980 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Acute Kidney Injury

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

Limitations and Caveats

Study was early terminated after enrollment of 4 participants due to very slow recruitment rates. Sample size was 4 participants instead of planned 1164 participants, hence no statistical analyses were performed, no tables and listings were produced.

Results Point of Contact

• Title: Francois Tranquart, M.D., Ph.D.
• Organization: GE Healthcare

francois.tranquart@ge.com

00-44-1494-543037

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2017
• First Posted: April 18, 2017
• Study Start: February 8, 2018
• Primary Completion: September 13, 2018
• Study Completion: October 19, 2018
• Last Updated: December 17, 2019
• Results First Posted: December 17, 2019

Record last verified: 2019-11

Locations

PL (4); GB (2); US (17); CA (2); ES (3); BE (1)