Skip to content

A Phase III, Randomised, Double-Blind, Study to Assess the Efficacy, Safety and Tolerability of Baxdrostat in Combination with Dapagliflozin Compared with Dapagliflozin Alone on Chronic Kidney Disease (CKD) Progression in Participants with CKD and High Blood Pressure

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-506457-38-00
Acronym
D6972C00003
Enrollment
675
Registered
2024-05-22
Start date
2024-06-05
Completion date
Unknown
Last updated
2025-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic kidney disease (CKD) and hypertension.

Brief summary

Change from baseline in eGFR to post treatment.

Detailed description

1. Change from baseline in UACR., 2. Change from baseline in systolic BP (blood pressure)., 3. Kidney hierarchical composite endpoint.* *Defined as the most severe outcome of the following: 1. Death; 2. KFRT (chronic dialysis or kidney transplant); 3. Sustained GFR < 15 mL/min/1.73 m2; 4. Sustained GFR decline from baseline of ≥ 57%; 5 Sustained GFR decline from baseline of ≥ 50%; or 6. individual change from baseline to post-treatment eGFR if none of the outcomes occurred., 4. Change in eGFR from following randomisation., 5. Time to the first occurrence of any of the components of the composite of: 1) CV death 2) HF with and without hospitalisation 3) MI 4) Stroke

Interventions

DRUGForxiga 10 mg film-coated tablets

Sponsors

Astrazeneca AB
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Change from baseline in eGFR to post treatment.

Secondary

MeasureTime frame
1. Change from baseline in UACR., 2. Change from baseline in systolic BP (blood pressure)., 3. Kidney hierarchical composite endpoint.* *Defined as the most severe outcome of the following: 1. Death; 2. KFRT (chronic dialysis or kidney transplant); 3. Sustained GFR < 15 mL/min/1.73 m2; 4. Sustained GFR decline from baseline of ≥ 57%; 5 Sustained GFR decline from baseline of ≥ 50%; or 6. individual change from baseline to post-treatment eGFR if none of the outcomes occurred., 4. Change in eGFR from following randomisation., 5. Time to the first occurrence of any of the components of the composite of: 1) CV death 2) HF with and without hospitalisation 3) MI 4) Stroke

Countries

Belgium, Bulgaria, Czechia, Denmark, France, Germany, Greece, Hungary, Italy, Netherlands, Poland, Romania, Slovakia, Spain, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026