Renal Impairment
Conditions
Keywords
Renal, Kidney, Contrast Induced Nephropathy
Brief summary
The purpose of this study is to evaluate the contrast-induced nephropathy (CIN) rate in subjects randomized to receive either Ioversol or Iodixanol for contrast-enhanced computed tomography.
Detailed description
Contrast-induced nephropathy (CIN) is an acute decline in renal function after the administration of iodinated contrast agents. CIN is commonly defined as an increase in post contrast serum creatinine (SCr) greater than or equal to 25% or an absolute increase greater than or equal to 0.5 mg/dL from pre contrast baseline values. Study will evaluate and compare the effects of two (2) contrast media products on renal function in subjects with stable reduced renal function while undergoing contrast-enhanced computed tomography.
Interventions
DRUGIoversol 320 mgI/mL
125 mL of Ioversol administered in the vein
125 mL of Iodixanol administered in the vein
Sponsors
Guerbet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Males and females 18 years of age or older * Subjects scheduled for a clinically indicated CECT requiring 40 grams of iodine (125 mL) * Subjects have an abnormal screening SCr that results in a calculated eGFR of \< 60 mL/min/1.73 m2 using the MDRD formula and acute causes for an elevation in SCr have been excluded * Subjects have stable reduced renal function which is defined as an abnormal screening SCr measurement with a \< 15% difference from the oldest historical SCr measurement obtained within the proceeding 1 week to 12 weeks * Subjects must provide written consent and agree to abide by the site and study requirements
Exclusion criteria
* Subjects previously entered into this study * Subjects on dialysis * Subjects received any investigational drug within 30 days of contrast administration or participated in an investigational study within 30 days prior to study enrollment * Subjects have undergone a procedure using iodinated or gadolinium contrast agent within 7 days prior to contrast administration, or is scheduled to receive additional doses of contrast agents during the 48-72 hour post-study contrast administration * Subjects in acute renal failure or have one or more known causes of acute renal failure * Subjects have known or suspected unstable renal function * Subjects scheduled for a surgical intervention or other procedure within 72 hours after the contrast administration * Subjects taking NSAIDs (with the exception of ASA) and/or any type of diuretics who cannot discontinue these drugs post contrast administration and hold all subsequent doses until the 48-72 hour post contrast SCr has been drawn * Subjects taking aminoglycosides * Subjects known to have an organ transplantation * Subjects have severe congestive heart failure (Class III-IV)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients With Contrast-induced Nephropathy (CIN) | Based on the SCr values of each patient measured from 2 to 24 hours before and from 48 to 72 hours after contrast medium administration | Contrast-induced nephropathy (CIN) is defined as an increase of ≥ 25% or an increase of ≥ 0.5 mg/dL from baseline serum creatinine (SCr), within 48 - 72 hours after contrast medium administration. For each patient, SCr values were measured from 2 to 24 hours before and from 48 to 72 hours after contrast medium administration. |
Countries
United States
Participant flow
Recruitment details
A total of 6 patients signed an informed consent for the study and therefore were considered as included
Participants by arm
| Arm | Count |
|---|---|
| IodixanoI Patients randomized to receive iodixanol 320 mgI/mL. | 2 |
| IoversoI Patients randomized to receive ioversol 320 mgI/mL. | 4 |
| Total | 6 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 |
Baseline characteristics
| Characteristic | IodixanoI | IoversoI | Total |
|---|---|---|---|
| Age, Continuous | 69.8 years STANDARD_DEVIATION 7 | 69.8 years STANDARD_DEVIATION 7 | 69.8 years STANDARD_DEVIATION 7 |
| Sex: Female, Male Female | 2 Participants | 3 Participants | 5 Participants |
| Sex: Female, Male Male | 0 Participants | 1 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 2 | 0 / 4 |
| other Total, other adverse events | 1 / 2 | 1 / 4 |
| serious Total, serious adverse events | 0 / 2 | 1 / 4 |
Outcome results
Primary
Percentage of Patients With Contrast-induced Nephropathy (CIN)
Contrast-induced nephropathy (CIN) is defined as an increase of ≥ 25% or an increase of ≥ 0.5 mg/dL from baseline serum creatinine (SCr), within 48 - 72 hours after contrast medium administration. For each patient, SCr values were measured from 2 to 24 hours before and from 48 to 72 hours after contrast medium administration.
Time frame: Based on the SCr values of each patient measured from 2 to 24 hours before and from 48 to 72 hours after contrast medium administration
Population: One patient from the Ioversol arm was prematurely withdrawn just after contrast medium administration due to the discovery of a new brain mass. Consequently, no SCr measurement was performed for this patient and the primary outcome could not be analyzed.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Iodixanol | Percentage of Patients With Contrast-induced Nephropathy (CIN) | 0 Participants |
| IoversoI | Percentage of Patients With Contrast-induced Nephropathy (CIN) | 0 Participants |