Kidney Damage In Patients With Severe Fall In eGFR

• Sponsor: Bracco Diagnostics, Inc (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT01136915
• Collaborator: (none)
• Enrollment: 15
• Location: 1
• Arms: 2
• Duration (Months): 24
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief Summary

This is a pilot study using a randomized, double blinded, comparison of two iodinated contrast agents used during percutaneous coronary intervention (PCI). All patients enrolled must have and estimated glomerular filtration [eGFR] < 30 mL/min/1.73 m2. Statistical summaries will be presented to analyse the various laboratory tests for the two groups.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Stenosis	Drug: Iopamidol 370; Drug: Iodixanol 320	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 15 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Diagnostic
• Official Title: A Phase IV Pilot Study to Evaluate Kidney Damage Measured by Neutrophil Gelatinase-Associated Lipocalin (NGAL) as a New Bio-Marker in Patients With Severe Fall in eGFR Undergoing Percutaneous Coronary Intervention With IOPAMIDOL Injection 370 or IODIXANOL 320
• Study Start Date: Nov 1, 2010
• Actual Primary Completion Date: Nov 1, 2012
• Actual Study Completion Date: Nov 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: IOPAMIDOL injection 370	Drug: Iopamidol 370; one time administration for PCI; Other Names: Isovue 370
Active Comparator: Iodixanol 320	Drug: Iodixanol 320; Iodixanol 320 single injection for percutaneous coronary injection

Outcome Measures

Primary Outcome Measures

1. 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. [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 contrast media.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Provides written Informed Consent

• Is at least 18 years of age;

• Is scheduled for or likely to undergo percutaneous coronary intervention;

• Has documented estimated glomerular filtration rate [eGFR] < 30 mL/min/1.73 m2 calculated with the MDRD formula within 72 hours prior the enrolment.

Exclusion Criteria:

• Is a pregnant or lactating female

• Has a history of severe congestive heart failure

• Has a history of hyperthyroidism

• Has unstable renal function

• Has a history of hypersensitivity to iodinated contrast agents

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institu De Cardiologie De Montreal	Montreal	Quebec	Canada

Sponsors and Collaborators

• Bracco Diagnostics, Inc

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bracco Diagnostics, Inc
• ClinicalTrials.gov Identifier: NCT01136915
• Other Study ID Numbers: IOP-118
• First Posted: Jun 4, 2010
• Last Update Posted: Mar 17, 2014
• Last Verified: Feb 1, 2014

• Additional relevant MeSH terms: Coronary Stenosis

Study Results

Participant Flow

Arm/Group Title	Iopamidol 370	Iodixanol 320
Arm/Group Description	Iopamidol 370: Non-ionic low-osmolar iodinated contrast media: single administration for percutaneous coronary intervention procedure	Iodixanol 320 Non-ionic iso-osmolar iodinated contrast media comparator: single administration for percutaneous coronary intervention procedure
Period Title: Overall Study
STARTED	8	7
COMPLETED	6	6
NOT COMPLETED	2	1

Baseline Characteristics

Arm/Group Title	Iopamidol 370	Iodixanol 320	Total
Arm/Group Description	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 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 of all reporting groups
Overall Participants	8	7	15
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	2 25%	2 28.6%	4 26.7%
>=65 years	6 75%	5 71.4%	11 73.3%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	69.5 (9.1)	67.7 (14.2)	68.7 (11.3)
Sex: Female, Male (Count of Participants)
Female	1 12.5%	2 28.6%	3 20%
Male	7 87.5%	5 71.4%	12 80%
Region of Enrollment (participants) [Number]
Canada	3 37.5%	1 14.3%	4 26.7%
China	5 62.5%	6 85.7%	11 73.3%

Outcome Measures

1. Primary Outcome

Title	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.
Description	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.
Time Frame	Baseline and 2,4,6,24, 48, and 72 hours post-dose

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Iopamidol 370 Serum NGAL	Iopamidol 370 Urine NGAL	Iodixanol 320 Serum NGAL	Iodixanol 320 Urine NGAL
Arm/Group Description	Serum NGAL (ng/mL) mean change from baseline at 2,4,6,24,48, and 72 hours post-administration of iopamidol 370	Urine NGAL (ng/mL) mean change from baseline at 2,4,6,24,and 48 hours post-administration of iopamidol 370	Serum NGAL (ng/mL) mean change from baseline at 2,4,6,24,48, and 72 hours post-administration of iodixanol 320	Urine NGAL (ng/mL) mean change from baseline at 2,4,6,24,and 48 hours post-administration of iodixanol 320
Measure Participants	6	6	6	6
2 hours post-dose	-33.03 (26.24)	-12.24 (54.13)	-103.23 (45.63)	-29.51 (55.67)
4 hours post-dose	-6.39 (33.26)	-29.98 (50.98)	-102.53 (65.80)	-52.09 (65.31)
6 hours post-dose	13.03 (32.60)	-10.81 (26.01)	-45.53 (101.85)	-51.00 (65.46)
24 hours post-dose	38.76 (79.94)	22.51 (61.31)	-20.13 (76.28)	-20.75 (36.89)
48 hours post-dose	28.08 (83.99)	37.78 (35.34)	-90.34 (79.20)	30.09 (106.75)
72 hours post-dose	-16.88 (33.76)	NA (NA)	-25.89 (161.56)	NA (NA)

Adverse Events

Arm/Group Title	Iopamidol 370		Iodixanol 320
Arm/Group Description	Iopamidol 370: Non-ionic low-osmolar iodinated contrast media: single administration for percutaneous coronary intervention procedure		Iodixanol 320 Non-ionic iso-osmolar iodinated contrast media comparator: single administration for percutaneous coronary intervention procedure
All Cause Mortality
	Iopamidol 370		Iodixanol 320
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Iopamidol 370		Iodixanol 320
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/8 (0%)		0/7 (0%)
Other (Not Including Serious) Adverse Events
	Iopamidol 370		Iodixanol 320
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/8 (0%)		0/7 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.