Trial Outcomes & Findings for A Study to Explore the Renal Safety of Visipaque Injection 320 mgI/mL in Patients With Chronic Kidney Disease (NCT NCT03119662)
NCT ID: NCT03119662
Last Updated: 2019-12-17
Results Overview
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.
TERMINATED
PHASE4
4 participants
48 hours post-baseline (Follow-up 1)
2019-12-17
Participant Flow
The Study was conducted at 29 sites in United States of America \& Europe from 8 February 2018 to 19 October 2018. A total of 4 participants with Chronic Kidney Disease (CKD) stage III/IV were enrolled in the study.
Participants were randomized in 1:1 ratio to undergo either contrast-enhanced computed tomography (CECT) or non-enhanced computed tomography (NECT), of which 1 participant withdrew from study.
Participant milestones
| Measure |
Visipaque™: Contrast-Enhanced Computed Tomography (CECT)
Participants received 1 intravenous injection of Visipaque™ 320 mg I/ml injection (100 mL iodixanol) and underwent computed tomography (CT) examination.
|
Saline: Non-Enhanced Computed Tomography (NECT)
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.
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
2
|
|
Overall Study
COMPLETED
|
2
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Visipaque™: Contrast-Enhanced Computed Tomography (CECT)
Participants received 1 intravenous injection of Visipaque™ 320 mg I/ml injection (100 mL iodixanol) and underwent computed tomography (CT) examination.
|
Saline: Non-Enhanced Computed Tomography (NECT)
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.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
A Study to Explore the Renal Safety of Visipaque Injection 320 mgI/mL in Patients With Chronic Kidney Disease
Baseline characteristics by cohort
| Measure |
Visipaque™: Contrast-Enhanced Computed Tomography (CECT)
n=2 Participants
Participants received 1 intravenous injection of Visipaque™ 320 mg I/ml injection (100 mL iodixanol) and underwent CT examination.
|
Saline: Non-Enhanced Computed Tomography (NECT)
n=2 Participants
Participants received 1 intravenous injection of saline placebo (matched to Visipaque™ 320 mg I/ml injection) and underwent CT examination and supplemental non-contrast duplex ultrasonography imaging examination.
|
Total
n=4 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 48 hours post-baseline (Follow-up 1)Population: Data were not collected, as planned analysis could not be performed due to early study termination.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 48 hours post-baseline (Follow-up 1)Population: Data were not collected, as planned analysis could not be performed due to early study termination.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 48 hours post-baseline (Follow-up 1)Population: Data were not collected, as planned analysis could not be performed due to early study termination.
Standard definition of CIN: Increase in SCr of 0.5 mg/dL or more in the 24 to 72 hours after the CT scan.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 48 hours post-baseline (Follow-up 1)Population: Data were not collected, as planned analysis could not be performed due to early study termination.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From Baseline to Month 6Population: Data were not collected, as planned analysis could not be performed due to early study termination.
Mortality (all cause death) and morbidity i.e. critical events.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Month 6Population: Data were not collected, as planned analysis could not be performed due to early study termination.
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).
Outcome measures
Outcome data not reported
Adverse Events
Visipaque™: Contrast-Enhanced Computed Tomography (CECT)
Saline: Non-Enhanced Computed Tomography (NECT)
Serious adverse events
| Measure |
Visipaque™: Contrast-Enhanced Computed Tomography (CECT)
n=2 participants at risk
Participants received 1 intravenous injection of Visipaque™ 320 mg I/ml injection (100 mL iodixanol) and underwent CT examination.
|
Saline: Non-Enhanced Computed Tomography (NECT)
n=2 participants at risk
Participants received 1 intravenous injection of saline placebo (matched to Visipaque™ 320 mg I/ml injection) and underwent CT examination and supplemental non-contrast duplex ultrasonography imaging examination.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Humerus Fracture
|
50.0%
1/2 • Number of events 1 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (Month 6) regardless of seriousness or relationship to investigational product.
Reported AEs are study-emergent AEs that is AEs that developed/worsened during any time after randomization until end of the follow-up period (Month 6). Analysis was performed on safety population which included all participants who were randomized to receive Visipaque™ or saline placebo and had post-randomization observations.
|
0.00%
0/2 • All Adverse Events (AEs) were collected from randomization until the end of the follow-up period (Month 6) regardless of seriousness or relationship to investigational product.
Reported AEs are study-emergent AEs that is AEs that developed/worsened during any time after randomization until end of the follow-up period (Month 6). Analysis was performed on safety population which included all participants who were randomized to receive Visipaque™ or saline placebo and had post-randomization observations.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The only disclosure restriction on the PI and/or institution is that the Sponsor can review results communications prior to public release and can restrict communications regarding trial results for a period that is more than 30 days (publications/abstracts) but not to exceed 90 days (patent related issues) from the time submitted to the Sponsor to review. The PI may be asked to remove any Sponsor confidential information and/or delay publication to protect any proprietary information.
- Publication restrictions are in place
Restriction type: OTHER