Baxdrostat + Dapagliflozin for Chronic Kidney Disease and High Blood Pressure

(BaxDuo-Pacific Trial)

Recruiting at 531 trial locations

Overseen By AstraZeneca Clinical Study Information Center

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: AstraZeneca

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

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

Eligibility Criteria

This trial is for people with chronic kidney disease and high blood pressure. Participants should not have other serious health conditions that could interfere with the study or be at risk of rapid progression to kidney failure.

Inclusion Criteria

I am not on any new immunosuppression drugs except for stable maintenance ones.

My kidney function is moderately reduced, and I have protein in my urine.

I have a documented history of adrenal insufficiency.

Exclusion Criteria

Known hyperkalaemia defined as potassium of ≥ 5.5 mmol/L within 3 months prior to screening.

Systolic blood pressure > 180 mmHg, or diastolic BP > 110 mmHg at screening.

I have not had dialysis in the last 3 months.

Treatment Details

Interventions

• Baxdrostat (Corticosteroid)
• Dapagliflozin (SGLT2 Inhibitor)

Trial Overview The study tests Baxdrostat combined with Dapagliflozin against a placebo/dapagliflozin combo. It's international, multicenter, double-blind (meaning neither doctors nor patients know who gets what), and focuses on how well kidneys work and heart health.

Participant Groups

Group I: Baxdrostat/dapagliflozin Experimental Treatment 1 Intervention

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.

Group II: Placebo/dapagliflozin Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

AstraZeneca

Lead Sponsor

Trials

4,491

Recruited

290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology