Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Bayer
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Men who agree to use adequate contraception when sexually active or women without childbearing potential
Not on dialysis at study entry
Serum ferritin levels ≥ 100 μg/L and \< 1000 μg/L or transferrin saturation ≥ 20%
You may not be if
A scheduled kidney transplant or any other organ transplant within the next 6 months (being on a waiting list does not exclude the subject)
Red blood cell (RBC) containing transfusion within the 8 weeks before baseline
Phosphodiesterase type 5 (PDE5) inhibitor (e.g., sildenafil, vardenafil, tadalafil) or nitrates
Sustained, poorly controlled arterial hypertension or hypotension at baseline, defined as blood pressure ≥ 180/110 mmHg or systolic blood pressure \< 95 mmHg, respectively
Severe rhythm or conduction disorders (e.g., heart rate \[HR\] \< 50 or \> 110 bpm, atrial flutter, prolonged QT \> 500 msec, second or third degree atrioventricular \[AV\] block), if not reacted with a pace marker)
New York Heart Association Class III or IV congestive heart failure
Severe hepatic insufficiency (defined as alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\]\>3x the upper limit of normal \[ULN\], total bilirubin \> 2 mg/dL, or Child Pugh B or C) or active hepatitis, in the investigator's opinion
An ongoing serious adverse event (SAE) from Study 15141 or Study 15261 that is assessed as related to study drug
