Coronary Artery Disease, Kidney Diseases
Conditions
Keywords
regadenoson, chronic kidney disease stage III, chronic kidney disease stage IV, renal impairment, coronary artery disease
Brief summary
This study is intended to assess the safety and tolerance of regadenoson in subjects with renal impairment.
Interventions
DRUGRegadenoson
IV
DRUGPlacebo
IV
Sponsors
Astellas Pharma Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Matching intravenous (IV) bolus injection | 170 |
| Regadenoson 0.4 mg/5 mL intravenous bolus injection | 334 |
| Total | 504 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Randomized, but drug not received | 4 | 3 |
Baseline characteristics
| Characteristic | Placebo | Regadenoson | Total |
|---|---|---|---|
| Age Continuous | 66.1 years STANDARD_DEVIATION 10.91 | 66.4 years STANDARD_DEVIATION 11.25 | 66.3 years STANDARD_DEVIATION 11.12 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 1 participants | 0 participants | 1 participants |
| Race/Ethnicity, Customized Asian | 6 participants | 10 participants | 16 participants |
| Race/Ethnicity, Customized Black or African American | 47 participants | 68 participants | 115 participants |
| Race/Ethnicity, Customized Native Hawaiian - Other Pacific Islander | 1 participants | 0 participants | 1 participants |
| Race/Ethnicity, Customized Other | 0 participants | 2 participants | 2 participants |
| Race/Ethnicity, Customized White | 115 participants | 254 participants | 369 participants |
| Sex: Female, Male Female | 78 Participants | 150 Participants | 228 Participants |
| Sex: Female, Male Male | 92 Participants | 184 Participants | 276 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 20 / 170 | 184 / 334 |
| serious Total, serious adverse events | 1 / 170 | 0 / 334 |
Outcome results
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.
Time frame: 24 hours post dose
Population: The number of participants analyzed per arm represents Safety Analysis Set (SAF); all randomized subjects who received any amount of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Subject With Serious Treatment Emergent Adverse Events (TEAE) | 0 Subjects |
| Regadenoson | Number of Subject With Serious Treatment Emergent Adverse Events (TEAE) | 0 Subjects |