A Study of the Safety and Tolerance of Regadenoson in Subjects With Renal Impairment
A Phase 4, Multicenter, Double-Blind, Randomized, Placebo-controlled Study of the Safety and Tolerance of Regadenoson in Subjects With Renal Impairment
1 other identifier
interventional
511
1 country
41
Brief Summary
This study is intended to assess the safety and tolerance of regadenoson in subjects with renal impairment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Apr 2009
Shorter than P25 for phase_4
41 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 16, 2009
CompletedFirst Posted
Study publicly available on registry
March 18, 2009
CompletedStudy Start
First participant enrolled
April 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedResults Posted
Study results publicly available
January 31, 2011
CompletedMay 18, 2012
May 1, 2012
8 months
March 16, 2009
December 28, 2010
May 11, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Subject With Serious Treatment Emergent Adverse Events (TEAE)
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.
24 hours post dose
Study Arms (2)
Placebo
PLACEBO COMPARATORMatching intravenous (IV) bolus injection
Regadenoson
EXPERIMENTAL0.4 mg/5 mL intravenous bolus injection
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (41)
Unknown Facility
Anniston, Alabama, 36207, United States
Unknown Facility
Little Rock, Arkansas, 72204, United States
Unknown Facility
Bell Gardens, California, 90202, United States
Unknown Facility
Fullerton, California, 92835, United States
Unknown Facility
Garden Grove, California, 92845, United States
Unknown Facility
Los Angeles, California, 90017, United States
Unknown Facility
Los Angeles, California, 90022, United States
Unknown Facility
Mission Viejo, California, 92691, United States
Unknown Facility
Oakland, California, 94609, United States
Unknown Facility
Roseville, California, 95661, United States
Unknown Facility
Santa Ana, California, 92704, United States
Unknown Facility
Newark, Delaware, 19713, United States
Unknown Facility
Wilmington, Delaware, 19808, United States
Unknown Facility
Fort Lauderdale, Florida, 33308, United States
Unknown Facility
Miami, Florida, 33173, United States
Unknown Facility
Orlando, Florida, 32809, United States
Unknown Facility
Trinity, Florida, 34655, United States
Unknown Facility
Winter Park, Florida, 32789, United States
Unknown Facility
Ellijay, Georgia, 38540, United States
Unknown Facility
Chicago, Illinois, 60616, United States
Unknown Facility
Auburn, Maine, 04210, United States
Unknown Facility
Detroit, Michigan, 48202, United States
Unknown Facility
Flint, Michigan, 48504, United States
Unknown Facility
Minneapolis, Minnesota, 55415, United States
Unknown Facility
Ridgewood, New Jersey, 07450, United States
Unknown Facility
Somerset, New Jersey, 08873, United States
Unknown Facility
New York, New York, 10010, United States
Unknown Facility
Springfield Gardens, New York, 11413, United States
Unknown Facility
Springfield, Ohio, 45505, United States
Unknown Facility
Oklahoma City, Oklahoma, 73103, United States
Unknown Facility
Bend, Oregon, 97701, United States
Unknown Facility
Duncansville, Pennsylvania, 16635, United States
Unknown Facility
Indiana, Pennsylvania, 15701, United States
Unknown Facility
Tyrone, Pennsylvania, 16686, United States
Unknown Facility
Wyomissing, Pennsylvania, 19610, United States
Unknown Facility
Charleston, South Carolina, 29425, United States
Unknown Facility
Spartanburg, South Carolina, 29303, United States
Unknown Facility
Knoxville, Tennessee, 37920, United States
Unknown Facility
Houston, Texas, 77055, United States
Unknown Facility
Houston, Texas, 77074, United States
Unknown Facility
Sugar Grove, Texas, 77478, United States
Related Publications (1)
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.
PMID: 22259009BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and 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.
Results Point of Contact
- Title
- Senior Medical Director, Medical Affairs
- Organization
- Astellas Pharma Global Development
Study Officials
- STUDY DIRECTOR
Central Contact
Astellas Pharma Global Development
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 16, 2009
First Posted
March 18, 2009
Study Start
April 1, 2009
Primary Completion
December 1, 2009
Study Completion
December 1, 2009
Last Updated
May 18, 2012
Results First Posted
January 31, 2011
Record last verified: 2012-05