Study of the Effect of Haemodialysis on the Pharmacokinetics, Safety, and Tolerability of Balcinrenone/Dapagliflozin
← catalyst calendarNCT07754331 · readout in 105 d
Sponsored by AstraZeneca (industry) · AZN — their whole pipeline →. With Fortrea.
Phase
Phase 1
Status
Not yet recruiting
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
10estimated
Sites
1
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2026-08-05 | estimated | When the study began enrolling |
| Primary completion | 2026-12-02 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2026-12-02 | estimated | The whole study's end, after follow-up |
| First posted | 2026-08-10 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-08-10 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Kidney Failure
Intervention
- Drug: Balcinrenone/dapagliflozin
Primary outcomes
what the primary-completion date above is the date OFPK parameters AUCinf
measured Day 1 to 3 for each treatment period (each treatment period is 4 days)
PK Parameters AUClast
measured Day 1 to 3 for each treatment period (each treatment period is 4 days)
PK Parameters Cmax
measured Day 1 to 3 for each treatment period (each treatment period is 4 days)
PK parameters C24 from plasma
measured Day 1 to 3 for each treatment period (each treatment period is 4 days)
PK parameters tmax from plasma
measured Day 1 to 3 for each treatment period (each treatment period is 4 days)
PK parameters t1/2λz from plasma
measured Day 1 to 3 for each treatment period (each treatment period is 4 days)
PK parameters CLNR (balcinrenone only) from plasma
measured Day 1 to 3 for each treatment period (each treatment period is 4 days)
PK parameters CL/F from plasma
measured Day 1 to 3 for each treatment period (each treatment period is 4 days)
PK parameters AUC(t1-t2)_out from plasma
measured Day 1 to 3 for each treatment period (each treatment period is 4 days)
PK parameters CLD from dialysate
measured Day 1 to 3 for each treatment period (each treatment period is 4 days)
PK parameters AeD from dialysate
measured Day 1 to 3 for each treatment period (each treatment period is 4 days)
PK parameters feD from dialysate
measured Day 1 to 3 for each treatment period (each treatment period is 4 days)
PK parameters Vz/F from plasma
measured Day 1 to 3 for each treatment period (each treatment period is 4 days)
PK parameters AUC(t1-t2) from plasma
measured Day 1 to 3 for each treatment period (each treatment period is 4 days)
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