Trial Outcomes & Findings for Kidney Damage in Patients With Normal eGFR (NCT NCT01137786)

Last Updated: 2013-09-30

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 non-ionic low osmolar contrast media.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

49 participants

Primary outcome timeframe

Baseline and 2, 4, 6, 24, 48, and 72 hours post-dose

Results posted on

2013-09-30

Participant Flow

Participant milestones

Participant milestones
Measure	Iodixanol 320 Non ionic contrast media comparator : one time administration for PCI	Iopamidol 370 Non ionic contrast media comparator : one time administration for PCI
Overall Study STARTED	25	24
Overall Study COMPLETED	24	21
Overall Study NOT COMPLETED	1	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Iodixanol 320 Non ionic contrast media comparator : one time administration for PCI	Iopamidol 370 Non ionic contrast media comparator : one time administration for PCI
Overall Study Lost to Follow-up	0	2
Overall Study Withdrawal by Subject	1	1

Baseline Characteristics

Kidney Damage in Patients With Normal eGFR

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Iodixanol 320 NGAL Evaluable Population n=21 Participants Non-ionic contrast media comparator: one time administration for PCI	Iopamidol 370 NGAL Evaluable Population n=21 Participants Non-ionic contrast media comparator: one time administration for PCI	Total n=42 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	11 Participants n=5 Participants	10 Participants n=7 Participants	21 Participants n=5 Participants
Age, Categorical >=65 years	10 Participants n=5 Participants	11 Participants n=7 Participants	21 Participants n=5 Participants
Age Continuous	62.0 years STANDARD_DEVIATION 10.65 • n=5 Participants	63.4 years STANDARD_DEVIATION 12.82 • n=7 Participants	62.7 years STANDARD_DEVIATION 11.66 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants	16 Participants n=7 Participants	33 Participants n=5 Participants
Region of Enrollment United States	17 participants n=5 Participants	16 participants n=7 Participants	33 participants n=5 Participants
Region of Enrollment Italy	4 participants n=5 Participants	5 participants n=7 Participants	9 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 2, 4, 6, 24, 48, and 72 hours post-dose

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 non-ionic low osmolar contrast media.

Outcome measures

Outcome measures
Measure	Iodixanol 320 Serum NGAL n=21 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=21 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=21 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=21 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 NGAL Following the Administration of Non-ionic Low Osmolar Contrast Media. 72 hours post-dose	18.34 ng/mL Standard Deviation 52.28	NA ng/mL Standard Deviation NA Urine NGAL not measured at this time point as per protocol.	26.59 ng/mL Standard Deviation 48.13	NA ng/mL Standard Deviation NA Urine NGAL not measured at this time point as per protocol.
Impact on the Trajectory of Serum and Urinary NGAL Following the Administration of Non-ionic Low Osmolar Contrast Media. 2 hours post-dose	-14.84 ng/mL Standard Deviation 35.46	-17.71 ng/mL Standard Deviation 49.04	-9.98 ng/mL Standard Deviation 22.80	-2.37 ng/mL Standard Deviation 5.45
Impact on the Trajectory of Serum and Urinary NGAL Following the Administration of Non-ionic Low Osmolar Contrast Media. 4 hours post-dose	-12.86 ng/mL Standard Deviation 30.57	-29.33 ng/mL Standard Deviation 64.65	-5.93 ng/mL Standard Deviation 26.62	-2.70 ng/mL Standard Deviation 7.09
Impact on the Trajectory of Serum and Urinary NGAL Following the Administration of Non-ionic Low Osmolar Contrast Media. 6 hours post-dose	-16.36 ng/mL Standard Deviation 28.77	-17.90 ng/mL Standard Deviation 51.38	-5.60 ng/mL Standard Deviation 24.50	-2.29 ng/mL Standard Deviation 7.66
Impact on the Trajectory of Serum and Urinary NGAL Following the Administration of Non-ionic Low Osmolar Contrast Media. 24 hours post-dose	28.35 ng/mL Standard Deviation 39.21	-2.10 ng/mL Standard Deviation 46.94	20.15 ng/mL Standard Deviation 32.74	2.31 ng/mL Standard Deviation 8.70
Impact on the Trajectory of Serum and Urinary NGAL Following the Administration of Non-ionic Low Osmolar Contrast Media. 48 hours post-dose	18.76 ng/mL Standard Deviation 62.77	-14.60 ng/mL Standard Deviation 34.69	34.03 ng/mL Standard Deviation 46.27	7.37 ng/mL Standard Deviation 22.84

Adverse Events

Iodixanol 320

Serious events: 1 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

Serious adverse events
Measure	Iodixanol 320 n=25 participants at risk Non ionic contrast media comparator : one time administration for PCI	Iopamidol 370 n=24 participants at risk Non ionic contrast media comparator : One time administration for PCI
Cardiac disorders Ventricular Fibrillation	4.0% 1/25 • Number of events 1	0.00% 0/24

Other adverse events

Adverse event data not reported

Additional Information

Maria Luigia Storto, M.D.

Bracco Diagnostics Inc.

Phone: 609-514-2262

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60