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

Phase 4

Completed

• Conditions: Kidney Diseases; Coronary Artery Disease
• Interventions: Drug: Placebo; Drug: Regadenoson

• Registration Number: NCT00863707
• Lead Sponsor: Astellas Pharma Inc

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-03-16
• Study First Submitted QC: 2009-03-16
• Study First Posted: 2009-03-18
• Study Start: 2009-04
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Results First Submitted: 2010-12-28
• Results First Submitted QC: 2010-12-28
• Results First Posted: 2011-01-31
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-11
• Last Update Posted: 2012-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 511

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Matching intravenous (IV) bolus injection
Regadenoson	Regadenoson	0.4 mg/5 mL intravenous bolus injection

Primary Outcome Measures

Name	Time	Method
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.