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

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

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

Conditions
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Kidney Diseases, Coronary Artery Disease

Intervention / Treatment
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* Drug: Regadenoson
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Matching intravenous (IV) bolus injection | Drug: Placebo<br>* IV<br>|
| Experimental: Regadenoson<br>0.4 mg/5 mL intravenous bolus injection | Drug: Regadenoson<br>* IV<br>* Other names: Lexiscan;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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regadenoson, chronic kidney disease stage III, chronic kidney disease stage IV, renal impairment, coronary artery disease