Trial Outcomes & Findings for Kidney Damage in Patients With Moderate Fall in eGFR (NCT NCT01136876)
NCT ID: NCT01136876
Last Updated: 2020-11-04
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
COMPLETED
Study phase
PHASE4
Target enrollment
57 participants
Primary outcome timeframe
Baseline and 2, 4, 6, 24, 48,and 72 hours post-dose
Results posted on
2020-11-04
Participant Flow
Participant milestones
| Measure |
Iodixanol 320
Iodixanol 320, a non-ionic iso-osmolar iodinated contrast media comparator, was administered as a single 652 mg dose for percutaneous coronary intervention procedure
|
Iopamidol 370
Iopamidol 370, a non-ionic low-osmolar iodinated contrast media, was administered as a single 755 mg dose for percutaneous coronary intervention procedure
|
|---|---|---|
|
Overall Study
STARTED
|
28
|
29
|
|
Overall Study
COMPLETED
|
23
|
18
|
|
Overall Study
NOT COMPLETED
|
5
|
11
|
Reasons for withdrawal
| Measure |
Iodixanol 320
Iodixanol 320, a non-ionic iso-osmolar iodinated contrast media comparator, was administered as a single 652 mg dose for percutaneous coronary intervention procedure
|
Iopamidol 370
Iopamidol 370, a non-ionic low-osmolar iodinated contrast media, was administered as a single 755 mg dose for percutaneous coronary intervention procedure
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Physician Decision
|
3
|
5
|
|
Overall Study
Missing NGAL measurement
|
2
|
5
|
Baseline Characteristics
Kidney Damage in Patients With Moderate Fall in eGFR
Baseline characteristics by cohort
| Measure |
Iodixanol 320
n=28 Participants
Iodixanol 320 Non-ionic iso-osmolar iodinated contrast media comparator: single administration for percutaneous coronary intervention procedure
|
Iopamidol 370
n=29 Participants
Iopamidol 370 Non-ionic low-osmolar iodinated contrast media: single administration for percutaneous coronary intervention procedure
|
Total
n=57 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
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
23 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Age, Continuous
|
71.1 years
STANDARD_DEVIATION 7.4 • n=5 Participants
|
73.3 years
STANDARD_DEVIATION 10.0 • n=7 Participants
|
72.2 years
STANDARD_DEVIATION 8.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
18 participants
n=5 Participants
|
20 participants
n=7 Participants
|
38 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
10 participants
n=5 Participants
|
9 participants
n=7 Participants
|
19 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 2, 4, 6, 24, 48,and 72 hours post-dosePopulation: A total of 41 patients met the evaluable criteria for NGAL analysis, 18 patients that were administered iopamidol 370, and 23 patients that were administered iodixanol 320.
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.
Outcome measures
| Measure |
Iodixanol 320 Serum NGAL
n=23 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=23 Participants
Urine NGAL (ng/mL) mean change from baseline at 2,4,6,24, and 48 hours post-administration of iodixanol 320
|
Iopamidol 370 Serum NGAL
n=18 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=18 Participants
Urine NGAL (ng/mL) mean change from baseline at 2,4,6,24,and 48 hours post-administration of iopamidol 370
|
|---|---|---|---|---|
|
Impact on the Trajectory of Serum and Urinary Neutrophil Gelatinase-associated Lipocalin (NGAL) Following Administration
6 hours post-dose
|
-15.83 ng/mL
Standard Deviation 47.06
|
-6.88 ng/mL
Standard Deviation 10.61
|
-17.61 ng/mL
Standard Deviation 37.28
|
-7.70 ng/mL
Standard Deviation 7.44
|
|
Impact on the Trajectory of Serum and Urinary Neutrophil Gelatinase-associated Lipocalin (NGAL) Following Administration
2 hours post-dose
|
-27.76 ng/mL
Standard Deviation 51.89
|
-11.11 ng/mL
Standard Deviation 16.32
|
-11.84 ng/mL
Standard Deviation 30.49
|
-8.23 ng/mL
Standard Deviation 9.90
|
|
Impact on the Trajectory of Serum and Urinary Neutrophil Gelatinase-associated Lipocalin (NGAL) Following Administration
4 hours post-dose
|
-27.06 ng/mL
Standard Deviation 46.03
|
-10.68 ng/mL
Standard Deviation 15.10
|
-14.66 ng/mL
Standard Deviation 42.24
|
-4.87 ng/mL
Standard Deviation 15.06
|
|
Impact on the Trajectory of Serum and Urinary Neutrophil Gelatinase-associated Lipocalin (NGAL) Following Administration
24 hours post-dose
|
15.89 ng/mL
Standard Deviation 78.14
|
-5.85 ng/mL
Standard Deviation 15.68
|
35.06 ng/mL
Standard Deviation 85.39
|
4.46 ng/mL
Standard Deviation 18.03
|
|
Impact on the Trajectory of Serum and Urinary Neutrophil Gelatinase-associated Lipocalin (NGAL) Following Administration
48 hours post-dose
|
22.88 ng/mL
Standard Deviation 59.34
|
-0.85 ng/mL
Standard Deviation 16.57
|
54.54 ng/mL
Standard Deviation 52.62
|
11.18 ng/mL
Standard Deviation 21.60
|
|
Impact on the Trajectory of Serum and Urinary Neutrophil Gelatinase-associated Lipocalin (NGAL) Following Administration
72 hours post-dose
|
22.32 ng/mL
Standard Deviation 60.51
|
NA ng/mL
Standard Deviation NA
Urine NGAL not measured at 72 hours post-dose as per protocol.
|
33.18 ng/mL
Standard Deviation 52.92
|
NA ng/mL
Standard Deviation NA
Urine NGAL not measured at 72 hours post-dose as per protocol.
|
Adverse Events
Iodixanol 320
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Iopamidol 370
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