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)
- Conditions
- use of contrastfluid in CKD10029149
- Registration Number
- NL-OMON46580
- Lead Sponsor
- GE Healthcare Ltd. and its Affiliates
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 15
(1) Is *18 years of age at the time that written informed consent is obtained.
(2) Is male or is a nonpregnant, nonlactating female who is either surgically sterile (has a documented bilateral tubal ligation or oophorectomy and/or documented hysterectomy) or is postmenopausal (cessation of menses for more than 1 year). Women of childbearing potential must use adequate contraception* from Screening until 30 days after the Baseline Visit and must have a negative result for a urine human chorionic gonadotropin pregnancy test at the Baseline Visit.
(3) Is an outpatient who has undergone successful EVAR and is scheduled for his/her next post-procedural imaging follow-up examination.
(4) Has previously completed one or more of his or her post-EVAR surveillance imaging examination(s) that provided evidence on stable post-EVAR status.
(5) Has a documented diagnosis of stage III or IV (defined as 30* estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m² and 15 *eGFR <30 mL/min/1.73 m², respectively, according to the Modification of Diet in Renal Disease [MDRD] equation) CKD and stable renal function (last 2 SCr values within ±0.5 mg/dL of each other, with the most recent value within 7 days prior to the scheduled CT examination and the preceding value within 1 to 12 months before that).
(6) Is able to provide written informed consent.
(7) Is able and willing to comply with all study procedures as described in the protocol.
* Adequate contraception is based on those methods identified in the Clinical Trial Facilitation Group document [CTFG Guidance 2014] for clarification of effective contraception. Such methods include: combined (estrogen- and progestogen-containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, or transdermal); progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, or implantable); intrauterine device; intrauterine hormone-releasing system; bilateral tubal occlusion; vasectomized partner; sexual abstinence, progestogen-only oral hormonal contraception, where inhibition of ovulation is not the primary mode of action, male or female condom with or without spermicide cap, diaphragm or sponge with spermicide (refer to protocol Section 8.6).
Patients must be excluded from participating in this study if they meet any of the following criteria
(1) Is pregnant, lactating, is possibly pregnant, or is actively trying to conceive during the study period.
(2) Is a patient for whom an endoleak or other clinically meaningful EVAR-related complication (as
judged by the investigator) has already been discovered.
(3) Is a patient who is undergoing surveillance following a Thoracic Endovascular Repair (TEVAR)
(4) Has a known or suspected history of immediate or delayed hypersensitivity (including but not limited to hives, anaphylactoid or cardiovascular reactions, laryngeal edema, and bronchospasm) to iodine or any iodinated contrast medium.
(5) Is using metformin (e.g., Glucophage®) that cannot be discontinued for the period of 48 hours prior to the Baseline Visit and for at least 48 hours after the imaging procedure (renal function must be evaluated before metformin is resumed).
(6) Has been exposed to any intravascular iodinated contrast medium in the 7 days prior to the Baseline Visit.
(7) Has congestive heart failure (New York Heart Association [NYHA] Class IV) or hepatic failure/liver cirrhosis according to the investigator*s judgement.
(8) Has stage V CKD, defined as eGFR <15 mL/min/1.73 m² according to the MDRD equation.
(9) Has a pre-existing requirement for renal dialysis.
(10) Has undergone percutaneous transluminal renal angioplasty (PTRA) within 12 months before the index EVAR procedure or is scheduled to undergo PTRA during the study period.
(11) Has 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.
(12) Has 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.
(13) Has been previously enrolled in this study.
(14) Is using i.v. vasopressor or inotropic medications.
(15) Has 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 (renal function must be evaluated before any nephrotoxic medication is resumed) * with the exception of acetylsalicylic acid (Aspirin) at a dose of *100 mg daily (QD).
(16) Has been hospitalized within 30 days prior to Screening Visit for any reason other than practical purposes for management of tests or diagnostic assessments.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary outcome measure in this study will be the incidence of AKI stage *1<br /><br>(in accordance with AKIN SCr criteria ([AKIN 2015] [Mehta et al. 2007])</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary outcome measures will include:<br /><br>* Assessing the incidence of AKI stage *2 (in accordance with AKIN SCr<br /><br>criteria).<br /><br>* Assessing the incidence of AKI by other definitions (standard definition of<br /><br>CIN [Mehran and Nikolsky 2006] and AKI stages *2 by Waikar criteria [Waikar and<br /><br>Bonventre 2009]).<br /><br>* Assessing the incidence of AKI related morbidity and mortality at 6 months<br /><br>(Follow-Up 3). This will be assessed by an independent Critical Events<br /><br>Adjudication Committee (CEAC). The independent CEAC will be appointed at the<br /><br>commencement of the study before any patients are enrolled.<br /><br>* Assessment of image quality/diagnostic confidence. Exploratory outcome<br /><br>measures will include:<br /><br>* Changes in SCr, cystatin C, N-GAL, and NephroCheck® biomarkers from baseline<br /><br>up to 48 hours post<br /><br>contrast/saline infusion.<br /><br>* Determination of GFR as measured by an ORFM in a subset of patients.</p><br>