Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Balcinrenone/dapagliflozin · 3 trials · 3 indications
Time to first occurrence of any of the components of the composite: * CV death * Death from kidney failure * Onset of kidney failure * Initiation of maintenance dialysis or * Kidney transplantation * Sustained ≥ 50% decline from baseline in eGFR * HF with or without hospitalisation
To evaluate the effect of HD on the PK of balcinrenone/dapagliflozin
To evaluate the effect of HD on the PK of balcinrenone/dapagliflozin
To evaluate the effect of HD on the PK of balcinrenone/dapagliflozin
To evaluate the PK of balcinrenone/dapagliflozin in plasma in participants with kidney failure on HD
To evaluate the PK of balcinrenone/dapagliflozin in plasma in participants with kidney failure on HD
To evaluate the PK of balcinrenone/dapagliflozin in plasma in participants with kidney failure on HD
To evaluate the PK of balcinrenone/dapagliflozin in plasma in participants with kidney failure on HD
To evaluate the PK of balcinrenone/dapagliflozin in plasma in participants with kidney failure on HD
To evaluate the PK of balcinrenone/dapagliflozin in plasma in participants with kidney failure on HD
To evaluate the PK of balcinrenone/dapagliflozin in dialysate in participants with kidney failure on HD
To evaluate the PK of balcinrenone/dapagliflozin in dialysate in participants with kidney failure on HD
To evaluate the PK of balcinrenone/dapagliflozin in dialysate in participants with kidney failure on HD
To evaluate the PK of balcinrenone/dapagliflozin in plasma in participants with kidney failure on HD
To evaluate the PK of balcinrenone/dapagliflozin in plasma in participants with kidney failure on HD
To evaluate the PK of balcinrenone /dapagliflozin given as a single dose to healthy Chinese participants
To evaluate the PK of balcinrenone /dapagliflozin given as a single dose to healthy Chinese participants
To evaluate the PK of balcinrenone /dapagliflozin given as a single dose to healthy Chinese participants
To evaluate the PK of balcinrenone /dapagliflozin given as a single dose to healthy Chinese participants
To evaluate the PK of balcinrenone /dapagliflozin given as a single dose to healthy Chinese participants
To evaluate the PK of balcinrenone /dapagliflozin given as a single dose to healthy Chinese participants
To evaluate the PK of balcinrenone /dapagliflozin given as a single dose to healthy Chinese participants
To evaluate the PK of balcinrenone /dapagliflozin given as a single dose to healthy Chinese participants
To evaluate the PK of balcinrenone /dapagliflozin given as a single dose to healthy Chinese participants
To evaluate the PK of balcinrenone /dapagliflozin given as a single dose to healthy Chinese participants
| Arm | Type | Description |
|---|---|---|
| Balcinrenone/dapagliflozin | EXPERIMENTAL | Patient receives once daily 1 capsule balcinrenone 15 mg and dapagliflozin 10 mg and 1 placebo tablet matching dapagliflozin. |
| Dapagliflozin | ACTIVE_COMPARATOR | Patient receives once daily 1 placebo capsule matching balcinrenone and dapagliflozin and 1 tablet dapagliflozin 10 mg. |
| Sequence AB | OTHER | Participants will receive Treatment A (balcinrenone/dapagliflozin capsule administered 1,5 hours before the start of a 4-hour hemodialysis session) on Day 1. After a wash-out period of ≥ 7 days, participants will receive Treatment B (balcinrenone/dapagliflozin capsule administered 1 hour after the completion of a 4-hour hemodialysis session) |
| Sequence BA | OTHER | Participants will receive Treatment B (balcinrenone/dapagliflozin capsule administered 1 hour after the completionof a 4-hour hemodialysis session) on Day 1. After a wash-out period of ≥ 7 days, participants will receive Treatment A (balcinrenone/dapagliflozin capsule administered 1.5 hours before the start of a 4-hour hemodialysis session) |
| Name | Type | Description |
|---|---|---|
| Balcinrenone/dapagliflozin | DRUG | balcinrenone/dapagliflozin 15 mg/10 mg and matching placebo for dapagliflozin 10 mg |
| Dapagliflozin | DRUG | dapagliflozin 10 mg and matching placebo for balcinrenone/dapagliflozin |
Inclusion Criteria: * Age ≥ 18 years * Diagnosis of CKD and at least one of the following: 1. eGFR ≥ 15 to \< 45 mL/min/1.73 m2 AND: UACR ≥ 30 mg/g (central laboratory) or UACR ≥ 100 mg/g (local laboratory ) or UPCR ≥ 200 mg/g (local laboratory). 2. eGFR ≥ 15 to \< 30 mL/min/1.73 m2 and UACR \...
Balcinrenone is an investigational small molecule being developed by AstraZeneca PLC (AZN) as a combination product with dapagliflozin. It is being studied in healthy volunteers and in patients with chronic kidney disease, kidney failure, and hepatic impairment. The drug is in clinical development, including Phase 1 and Phase 3 trials.
Balcinrenone, in combination with dapagliflozin, is being studied for use in chronic kidney disease, specifically in patients with CKD stage 3b and 4. It is also being investigated in healthy participants and in patients with kidney failure or hepatic impairment to assess its safety and pharmacokinetics.
Balcinrenone is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker AZN. AstraZeneca is conducting clinical trials of the balcinrenone/dapagliflozin combination across multiple countries, including China, the United Kingdom, and the United States.
Balcinrenone is in clinical development, with trials in Phase 1 and Phase 3. The Phase 3 trial, BalanceD-CKD, is not yet recruiting and will evaluate the drug in patients with chronic kidney disease. Phase 1 trials have been completed in healthy participants to study pharmacokinetics.
Balcinrenone is being studied in several trials. NCT06651021 is a completed Phase 1 PK study in healthy Chinese participants. NCT06979388 is a completed Phase 1 food effect and drug interaction study. NCT07624305 is a Phase 3 trial in chronic kidney disease, and NCT07754331 is a Phase 1 study in kidney failure patients on haemodialysis.
Balcinrenone is the same as balcinrenone/dapagliflozin, which is the combination product being developed. The drug is studied as a fixed combination with dapagliflozin in clinical trials, and the name balcinrenone/dapagliflozin is used to refer to this investigational therapy.