Trial Outcomes & Findings for Kidney Damage In Patients With Severe Fall In eGFR (NCT NCT01136915)
NCT ID: NCT01136915
Last Updated: 2014-03-17
Results Overview
Mean change from baseline values for serum NGAL at 2,4,6,24,48, and 72 hours, and urine NGAL at 2,4,6,24, and 48 hours following the administration of contrast media.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
15 participants
Primary outcome timeframe
Baseline and 2,4,6,24, 48, and 72 hours post-dose
Results posted on
2014-03-17
Participant Flow
Participant milestones
| Measure |
Iopamidol 370
Iopamidol 370: Non-ionic low-osmolar iodinated contrast media: single administration for percutaneous coronary intervention procedure
|
Iodixanol 320
Iodixanol 320 Non-ionic iso-osmolar iodinated contrast media comparator: single administration for percutaneous coronary intervention procedure
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
7
|
|
Overall Study
COMPLETED
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
Iopamidol 370
Iopamidol 370: Non-ionic low-osmolar iodinated contrast media: single administration for percutaneous coronary intervention procedure
|
Iodixanol 320
Iodixanol 320 Non-ionic iso-osmolar iodinated contrast media comparator: single administration for percutaneous coronary intervention procedure
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
|
Overall Study
Exclusion criterion met
|
0
|
1
|
Baseline Characteristics
Kidney Damage In Patients With Severe Fall In eGFR
Baseline characteristics by cohort
| Measure |
Iopamidol 370
n=8 Participants
Iopamidol 370: Non-ionic low-osmolar iodinated contrast media: single intravenous administration for percutaneous coronary intervention procedure; dose was limited to the minimum volume required to achieve diagnostic information and/or guide therapeutic intervention.
|
Iodixanol 320
n=7 Participants
Iodixanol 320 Non-ionic iso-osmolar iodinated contrast media comparator: single intravenous administration for percutaneous coronary intervention procedure; dose was limited to the minimum volume required to achieve diagnostic information and/or guide therapeutic intervention.
|
Total
n=15 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
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Age, Continuous
|
69.5 years
STANDARD_DEVIATION 9.1 • n=5 Participants
|
67.7 years
STANDARD_DEVIATION 14.2 • n=7 Participants
|
68.7 years
STANDARD_DEVIATION 11.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
3 participants
n=5 Participants
|
1 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Region of Enrollment
China
|
5 participants
n=5 Participants
|
6 participants
n=7 Participants
|
11 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 2,4,6,24, 48, and 72 hours post-doseMean change from baseline values for serum NGAL at 2,4,6,24,48, and 72 hours, and urine NGAL at 2,4,6,24, and 48 hours following the administration of contrast media.
Outcome measures
| Measure |
Iopamidol 370 Serum NGAL
n=6 Participants
Serum NGAL (ng/mL) mean change from baseline at 2,4,6,24,48, and 72 hours post-administration of iopamidol 370
|
Iopamidol 370 Urine NGAL
n=6 Participants
Urine NGAL (ng/mL) mean change from baseline at 2,4,6,24,and 48 hours post-administration of iopamidol 370
|
Iodixanol 320 Serum NGAL
n=6 Participants
Serum NGAL (ng/mL) mean change from baseline at 2,4,6,24,48, and 72 hours post-administration of iodixanol 320
|
Iodixanol 320 Urine NGAL
n=6 Participants
Urine NGAL (ng/mL) mean change from baseline at 2,4,6,24,and 48 hours post-administration of iodixanol 320
|
|---|---|---|---|---|
|
Impact on the Trajectory of Serum and Urinary NGAL Following the Administration of Non-ionic, Low-osmolar Contrast Media in Comparison to a Non-ionic, Iso-osmolar Contrast Media.
2 hours post-dose
|
-33.03 ng/mL
Standard Deviation 26.24
|
-12.24 ng/mL
Standard Deviation 54.13
|
-103.23 ng/mL
Standard Deviation 45.63
|
-29.51 ng/mL
Standard Deviation 55.67
|
|
Impact on the Trajectory of Serum and Urinary NGAL Following the Administration of Non-ionic, Low-osmolar Contrast Media in Comparison to a Non-ionic, Iso-osmolar Contrast Media.
4 hours post-dose
|
-6.39 ng/mL
Standard Deviation 33.26
|
-29.98 ng/mL
Standard Deviation 50.98
|
-102.53 ng/mL
Standard Deviation 65.80
|
-52.09 ng/mL
Standard Deviation 65.31
|
|
Impact on the Trajectory of Serum and Urinary NGAL Following the Administration of Non-ionic, Low-osmolar Contrast Media in Comparison to a Non-ionic, Iso-osmolar Contrast Media.
6 hours post-dose
|
13.03 ng/mL
Standard Deviation 32.60
|
-10.81 ng/mL
Standard Deviation 26.01
|
-45.53 ng/mL
Standard Deviation 101.85
|
-51.00 ng/mL
Standard Deviation 65.46
|
|
Impact on the Trajectory of Serum and Urinary NGAL Following the Administration of Non-ionic, Low-osmolar Contrast Media in Comparison to a Non-ionic, Iso-osmolar Contrast Media.
24 hours post-dose
|
38.76 ng/mL
Standard Deviation 79.94
|
22.51 ng/mL
Standard Deviation 61.31
|
-20.13 ng/mL
Standard Deviation 76.28
|
-20.75 ng/mL
Standard Deviation 36.89
|
|
Impact on the Trajectory of Serum and Urinary NGAL Following the Administration of Non-ionic, Low-osmolar Contrast Media in Comparison to a Non-ionic, Iso-osmolar Contrast Media.
48 hours post-dose
|
28.08 ng/mL
Standard Deviation 83.99
|
37.78 ng/mL
Standard Deviation 35.34
|
-90.34 ng/mL
Standard Deviation 79.20
|
30.09 ng/mL
Standard Deviation 106.75
|
|
Impact on the Trajectory of Serum and Urinary NGAL Following the Administration of Non-ionic, Low-osmolar Contrast Media in Comparison to a Non-ionic, Iso-osmolar Contrast Media.
72 hours post-dose
|
-16.88 ng/mL
Standard Deviation 33.76
|
NA ng/mL
Standard Deviation NA
Urine NGAL not measured at 72 hours post-dose as per protocol.
|
-25.89 ng/mL
Standard Deviation 161.56
|
NA ng/mL
Standard Deviation NA
Urine NGAL not measured at 72 hours post-dose as per protocol.
|
Adverse Events
Iopamidol 370
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Iodixanol 320
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60