The purpose of this study is to investigate the effect of HD on single oral dose PK, safety, and tolerability of balcinrenone/dapagliflozin to male and female participants with kidney failure on intermittent HD.
Age range
18 Years – 80 Years
Sex
ALL
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Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
PK parameters AUCinf
Timeframe: Day 1 to 3 for each treatment period (each treatment period is 4 days)
PK Parameters AUClast
Timeframe: Day 1 to 3 for each treatment period (each treatment period is 4 days)
PK Parameters Cmax
Timeframe: Day 1 to 3 for each treatment period (each treatment period is 4 days)
PK parameters C24 from plasma
Timeframe: Day 1 to 3 for each treatment period (each treatment period is 4 days)
PK parameters tmax from plasma
Timeframe: Day 1 to 3 for each treatment period (each treatment period is 4 days)
PK parameters t1/2λz from plasma
Timeframe: Day 1 to 3 for each treatment period (each treatment period is 4 days)
PK parameters CLNR (balcinrenone only) from plasma
Timeframe: Day 1 to 3 for each treatment period (each treatment period is 4 days)
AstraZeneca Clinical Study Information Center
PK parameters CL/F from plasma
Timeframe: Day 1 to 3 for each treatment period (each treatment period is 4 days)
PK parameters AUC(t1-t2)_out from plasma
Timeframe: Day 1 to 3 for each treatment period (each treatment period is 4 days)
PK parameters CLD from dialysate
Timeframe: Day 1 to 3 for each treatment period (each treatment period is 4 days)
PK parameters AeD from dialysate
Timeframe: Day 1 to 3 for each treatment period (each treatment period is 4 days)
PK parameters feD from dialysate
Timeframe: Day 1 to 3 for each treatment period (each treatment period is 4 days)
PK parameters Vz/F from plasma
Timeframe: Day 1 to 3 for each treatment period (each treatment period is 4 days)
PK parameters AUC(t1-t2) from plasma
Timeframe: Day 1 to 3 for each treatment period (each treatment period is 4 days)