Clinical trial NCT00863707: A Study of the Safety and Tolerance of Regadenoson in Subjects With Renal Impairment
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Kidney Diseases
Coronary Artery Disease
Keywords: regadenoson
chronic kidney disease stage III
chronic kidney disease stage IV
renal impairment
coronary artery disease
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2009-03-18
Enrollment: 511
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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


Eligibility criteria: 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

Primary outcomes:
measure: Number of Subject With Serious Treatment Emergent Adverse Events (TEAE)
timeFrame: 24 hours post dose
Secondary outcomes:
Other outcomes:
Locations:
city: Anniston
country: United States
state: Alabama
city: Little Rock
country: United States
state: Arkansas
city: Bell Gardens
country: United States
state: California
city: Fullerton
country: United States
state: California
city: Garden Grove
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Mission Viejo
country: United States
state: California
city: Oakland
country: United States
state: California
city: Roseville
country: United States
state: California
city: Santa Ana
country: United States
state: California
city: Newark
country: United States
state: Delaware
city: Wilmington
country: United States
state: Delaware
city: Fort Lauderdale
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Trinity
country: United States
state: Florida
city: Winter Park
country: United States
state: Florida
city: Ellijay
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Auburn
country: United States
state: Maine
city: Detroit
country: United States
state: Michigan
city: Flint
country: United States
state: Michigan
city: Minneapolis
country: United States
state: Minnesota
city: Ridgewood
country: United States
state: New Jersey
city: Somerset
country: United States
state: New Jersey
city: New York
country: United States
state: New York
city: Springfield Gardens
country: United States
state: New York
city: Springfield
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Bend
country: United States
state: Oregon
city: Duncansville
country: United States
state: Pennsylvania
city: Indiana
country: United States
state: Pennsylvania
city: Tyrone
country: United States
state: Pennsylvania
city: Wyomissing
country: United States
state: Pennsylvania
city: Charleston
country: United States
state: South Carolina
city: Spartanburg
country: United States
state: South Carolina
city: Knoxville
country: United States
state: Tennessee
city: Houston
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Sugar Grove
country: United States
state: Texas
Study officials:
affiliation: Astellas Pharma Global Development
name: Central Contact
role: STUDY_DIRECTOR
References:
citation: 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.