CI

At a glance

ClinicalIndex Comparison Record
Phase 3Recruiting· 5,000 target
Drug / intervention
Baxdrostat/dapagliflozin +1 moredrug
Likely dose
Not stated in record
Key inclusion· 6
  • ✓Age ≥18 years at informed consent
  • ✓eGFR 30-59 mL/min/1.73 m² with UACR ≥30 mg/g or UACR ≥500 mg/g or UPCR ≥700 mg/g (specific ranges)
  • ✓eGFR 60-75 mL/min/1.73 m² with UACR ≥500 mg/g or UPCR ≥700 mg/g (specific ranges)
  • ✓History of hypertension with SBP ≥130 mmHg at screening and ≥120 mmHg at randomization
Key exclusion· 12
  • ✕SBP >180 mmHg or DBP >110 mmHg at screening
  • ✕Known hyperkalaemia (potassium ≥5.5 mmol/L within 3 months at screening)
  • ✕Serum sodium <135 mmol/L within 4 weeks prior to screening or at screening
  • ✕T1DM (with regional exceptions: US allows SGLT2i-treated; Japan allows dapagliflozin-treated)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06742723
NCT06742723Phase 3RecruitingHigh Momentum
CompareCT.gov

A Phase III, Randomised, Double-blind, Placebo-controlled, Event-driven Study to Assess the Efficacy, Safety and Tolerability of Baxdrostat in Combination With Dapagliflozin Compared With Dapagliflozin Alone on Renal Outcomes and Cardiovascular Mortality in Participants With Chronic Kidney Disease and High Blood Pressure

AstraZeneca·interventional·Posted Dec 19, 2024·Updated Jun 26, 2026

In Brief

A Phase 3 clinical trial evaluating Baxdrostat/dapagliflozin and Placebo/dapagliflozin for Chronic Kidney Disease and Hypertension. Currently recruiting, targeting 5,000 participants across 764 sites in 42 countries.

Signals

Enrolling ahead of pace

Detailed Summary

International, Multicenter, Double-Blind, Placebo-Controlled and Event-driven study to assess efficacy, safety and Tolerability of Baxdrostat in combination with Dapagliflozin on renal outcomes and cardiovascular mortality in participants with chronic kidney disease and high blood pressure

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Kidney Disease and Hypertension
CountriesArgentina, Australia, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czechia, Denmark, Egypt, France, Germany, Greece, Hungary, India, Israel, Italy, Japan, Malaysia, Mexico, Netherlands, Peru, Philippines, Poland, Romania, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Taiwan, Thailand, Turkey (Türkiye), Ukraine, United Kingdom, United States, Vietnam
Collaborators--

Timeline

Phase 3Recruiting
202520262027202820292030
First PostedDec 19, 2024
Enrollment StartMar 3, 2025
Primary CompletionDec 18, 2029
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 1.5 years agoPrimary completion in 3.5 years

Arms & Interventions

Baxdrostat/dapagliflozinexperimental

Participants randomised to the baxdrostat/dapagliflozin arm will initially receive a lower dose of baxdrostat and standard dose dapagliflozin. For participants that meet the up-titration criteria, baxdrostat may be up-titrated to higher dose.

Drug: Baxdrostat/dapagliflozin
Placebo/dapagliflozinplacebo_comparator

Patients will receive one dose of dapagliflozin comparator in combination with matching placebo daily.

Drug: Placebo/dapagliflozin

Interventions

Baxdrostat/dapagliflozindrug

baxdrostat tablet dapagliflozin tablet

Placebo/dapagliflozindrug

dapagliflozin tablet placebo tablet