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

Coronary Artery Disease Clinical Trial

Official title:

A Phase 4, Multicenter, Double-Blind, Randomized, Placebo-controlled Study of the Safety and Tolerance of Regadenoson in Subjects With Renal Impairment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00863707
• Other study ID #: 3606-CL-3010
• Status: Completed
• Phase: Phase 4
• First received: March 16, 2009
• Last updated: May 11, 2012
• Start date: April 2009
• Est. completion date: December 2009

Study information

• Verified date: May 2012
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 511
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Kidney Diseases
• Myocardial Ischemia
• Renal Insufficiency

Intervention

Drug:
• Regadenoson
IV
• Placebo
IV

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No

External Links

•   Link to Prescribing Information