A Study of the Safety and Tolerance of Regadenoson in Subjects With Renal Impairment

• Sponsor: Astellas Pharma Inc (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00863707
• Collaborator: (none)
• Enrollment: 511
• Locations: 41
• Arms: 2
• Duration (Months): 8
• Patients Per Site: 12.5
• Patients Per Site Per Month: 1.6

Study Details

Study Description

Brief Summary

This study is intended to assess the safety and tolerance of regadenoson in subjects with renal impairment.

Condition or Disease	Intervention/Treatment	Phase
Kidney Diseases; Coronary Artery Disease	Drug: Regadenoson; Drug: Placebo	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 511 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Diagnostic
• Official Title: A Phase 4, Multicenter, Double-Blind, Randomized, Placebo-controlled Study of the Safety and Tolerance of Regadenoson in Subjects With Renal Impairment
• Study Start Date: Apr 1, 2009
• Actual Primary Completion Date: Dec 1, 2009
• Actual Study Completion Date: Dec 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo Matching intravenous (IV) bolus injection	Drug: Placebo; IV
Experimental: Regadenoson 0.4 mg/5 mL intravenous bolus injection	Drug: Regadenoson; IV; Other Names: CVT-3146 Lexiscan

Outcome Measures

Primary Outcome Measures

1. Number of Subject With Serious Treatment Emergent Adverse Events (TEAE) [24 hours post dose]

   The data represents the numbers of subjects reporting Serious TEAEs. TEAEs were defined as Adverse Events (AEs) starting or worsening after administration of the test drug.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Subject has a Stage III or Stage IV renal impairment based on the National Kidney Foundation (NKF) Kidney Disease Outcomes Quality Initiative (K/DOQI) glomerular filtration rate (GFR) classification

• Subject has a diagnosis of Coronary Artery Disease (CAD) or risk factors for CAD as determined by a current medical diagnosis of at least 2 of the following conditions: Type 2 diabetes, hypertension, hypercholesterolemia, current or history of cigarette smoking (minimum 10 pack-years exposure) or obesity (Body Mass Index (BMI) > 30)

• Subject must abstain from smoking 3 hours prior and 8 hours post study drug administration

• Subject must abstain from any intake of foods and beverages containing a methylated xanthine derivative (i.e. caffeine, theobromine, or methylxanthine) within 12 hours prior to study drug administration through the Follow-Up visit, as these foods may reduce the effects of regadenoson derivative (i.e. caffeine, theobromine, or methylxanthine) within 12 hours prior to study drug administration through the Follow-Up visit, as these foods may reduce the effects of regadenoson

Exclusion Criteria:

• Subject has a history of an additional clinically significant illness, medical condition, or laboratory abnormality within 2 weeks prior to Screening

• Female subject who is pregnant, lactating or of childbearing potential who refuses to use a medically acceptable form of contraception until the Follow-Up visit is complete

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Anniston	Alabama	United States	36207
2		Little Rock	Arkansas	United States	72204
3		Bell Gardens	California	United States	90202
4		Fullerton	California	United States	92835
5		Garden Grove	California	United States	92845
6		Los Angeles	California	United States	90017
7		Los Angeles	California	United States	90022
8		Mission Viejo	California	United States	92691
9		Oakland	California	United States	94609
10		Roseville	California	United States	95661
11		Santa Ana	California	United States	92704
12		Newark	Delaware	United States	19713
13		Wilmington	Delaware	United States	19808
14		Fort Lauderdale	Florida	United States	33308
15		Miami	Florida	United States	33173
16		Orlando	Florida	United States	32809
17		Trinity	Florida	United States	34655
18		Winter Park	Florida	United States	32789
19		Ellijay	Georgia	United States	38540
20		Chicago	Illinois	United States	60616
21		Auburn	Maine	United States	04210
22		Detroit	Michigan	United States	48202
23		Flint	Michigan	United States	48504
24		Minneapolis	Minnesota	United States	55415
25		Ridgewood	New Jersey	United States	07450
26		Somerset	New Jersey	United States	08873
27		New York	New York	United States	10010
28		Springfield Gardens	New York	United States	11413
29		Springfield	Ohio	United States	45505
30		Oklahoma City	Oklahoma	United States	73103
31		Bend	Oregon	United States	97701
32		Duncansville	Pennsylvania	United States	16635
33		Indiana	Pennsylvania	United States	15701
34		Tyrone	Pennsylvania	United States	16686
35		Wyomissing	Pennsylvania	United States	19610
36		Charleston	South Carolina	United States	29425
37		Spartanburg	South Carolina	United States	29303
38		Knoxville	Tennessee	United States	37920
39		Houston	Texas	United States	77055
40		Houston	Texas	United States	77074
41		Sugar Grove	Texas	United States	77478

Sponsors and Collaborators

• Astellas Pharma Inc

Investigators

• Study Director: Central Contact, Astellas Pharma Global Development

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Link to Prescribing Information

Publications

• Ananthasubramaniam K, Weiss R, McNutt B, Klauke B, Feaheny K, Bukofzer S. A randomized, double-blind, placebo-controlled study of the safety and tolerance of regadenoson in subjects with stage 3 or 4 chronic kidney disease. J Nucl Cardiol. 2012 Apr;19(2):319-29. doi: 10.1007/s12350-011-9508-3. Epub 2012 Jan 19.

• Responsible Party: Astellas Pharma Inc
• ClinicalTrials.gov Identifier: NCT00863707
• Other Study ID Numbers: 3606-CL-3010
• First Posted: Mar 18, 2009
• Last Update Posted: May 18, 2012
• Last Verified: May 1, 2012

• Keywords provided by Astellas Pharma Inc: regadenoson; chronic kidney disease stage III; chronic kidney disease stage IV; renal impairment; coronary artery disease
• Additional relevant MeSH terms: Kidney Diseases; Renal Insufficiency; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Regadenoson

Study Results

Participant Flow

Arm/Group Title	Placebo	Regadenoson
Arm/Group Description	Matching intravenous (IV) bolus injection	0.4 mg/5 mL intravenous bolus injection
Period Title: Overall Study
STARTED	174	337
COMPLETED	170	334
NOT COMPLETED	4	3

Baseline Characteristics

Arm/Group Title	Placebo	Regadenoson	Total
Arm/Group Description	Matching intravenous (IV) bolus injection	0.4 mg/5 mL intravenous bolus injection	Total of all reporting groups
Overall Participants	170	334	504
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	66.1 (10.91)	66.4 (11.25)	66.3 (11.12)
Sex: Female, Male (Count of Participants)
Female	78 45.9%	150 44.9%	228 45.2%
Male	92 54.1%	184 55.1%	276 54.8%
Race/Ethnicity, Customized (participants) [Number]
White	115 67.6%	254 76%	369 73.2%
Black or African American	47 27.6%	68 20.4%	115 22.8%
Asian	6 3.5%	10 3%	16 3.2%
American Indian or Alaska Native	1 0.6%	0 0%	1 0.2%
Native Hawaiian - Other Pacific Islander	1 0.6%	0 0%	1 0.2%
Other	0 0%	2 0.6%	2 0.4%

Outcome Measures

1. Primary Outcome

Title	Number of Subject With Serious Treatment Emergent Adverse Events (TEAE)
Description	The data represents the numbers of subjects reporting Serious TEAEs. TEAEs were defined as Adverse Events (AEs) starting or worsening after administration of the test drug.
Time Frame	24 hours post dose

Outcome Measure Data

Analysis Population Description

The number of participants analyzed per arm represents Safety Analysis Set (SAF); all randomized subjects who received any amount of study drug.

Arm/Group Title	Placebo	Regadenoson
Arm/Group Description	Matching intravenous (IV) bolus injection	0.4 mg/5 mL intravenous bolus injection
Measure Participants	170	334
Number [Subjects]	0	0

Adverse Events

Time Frame	Adverse Event collection began immediately following study drug administration through the follow-up visit. All Serious Adverse Events (SAEs) occurring until 30 days after dosing were reported.
Adverse Event Reporting Description	TEAEs were defined as AEs starting or worsening after starting administration of the test drug. Within a system organ class subjects may have reported more than one type of Adverse Event.
Arm/Group Title	Placebo		Regadenoson
Arm/Group Description	Matching intravenous (IV) bolus injection		0.4 mg/5 mL intravenous bolus injection
All Cause Mortality
	Placebo		Regadenoson
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Placebo		Regadenoson
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/170 (0.6%)		0/334 (0%)
Cardiac disorders
Death	1/170 (0.6%)		0/334 (0%)
Other (Not Including Serious) Adverse Events
	Placebo		Regadenoson
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	20/170 (11.8%)		184/334 (55.1%)
Gastrointestinal disorders
Nausea	2/170 (1.2%)		49/334 (14.7%)
General disorders
Chest discomfort	1/170 (0.6%)		49/334 (14.7%)
Nervous system disorders
Headache	12/170 (7.1%)		83/334 (24.9%)
Dizziness	1/170 (0.6%)		32/334 (9.6%)
Dysgeusia	6/170 (3.5%)		18/334 (5.4%)
Respiratory, thoracic and mediastinal disorders
Dyspnoea	1/170 (0.6%)		64/334 (19.2%)
Vascular disorders
Flushing	3/170 (1.8%)		40/334 (12%)

Limitations/Caveats

Company makes no warranties or representations of any kind as to the posting, expressed or implied, including warranties of merchantability and fitness for a particular purpose, and shall not be liable for any damages.

More Information

Certain Agreements

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

Institute and/or Principal Investigator may publish trial data generated at their specific study site after Sponsor publication of the multi-center data. Sponsor must receive a site's manuscript at least 30 days prior to publication to ensure that no confidential information of Sponsor is included in the document. Sponsor may delay the publication for an additional 60 days to seek patent protection.