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

Astellas

Status and phase

Completed

Phase 4

Conditions

Coronary Artery Disease

Kidney Diseases

Treatments

Drug: Regadenoson

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

3606-CL-3010

Details and patient eligibility

About

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

Enrollment

511 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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