drugset / Trial / NCT06742723
A Phase III Renal Outcomes and Cardiovascular Mortality Study to Investigate the Efficacy and Safety of Baxdrostat in Combination With Dapagliflozin in Participants With Chronic Kidney Disease and High Blood Pressure
RandomizedParallel-groupQuadruple-blindTreatment
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
Timeline
- Start
- 2025-03-03
- Primary completion
- 2029-12-18
- Completion
- 2029-12-18
Publications
- Yeung EK, Rangaswami J, Tuttle KR, Grams ME, Tangri N, Vaduganathan M, Neuen BL. A Framework for Risk-Based Implementation of Combination Therapy in CKD: Who, Why, When, and How? Clin J Am Soc Nephrol. 2026 Jun 23. doi: 10.2215/CJN.0000001158. Online ahead of print.
- Dwyer JP, Maklad N, Vedin O, Monyak J, Myte R, Chertow GM, Heerspink HJL, Little DJ. Efficacy and Safety of Baxdrostat in Participants with CKD and Uncontrolled Hypertension: A Randomized, Double-Blind, Placebo-Controlled Trial. J Am Soc Nephrol. 2026 Feb 1;37(2):299-311. doi: 10.1681/ASN.0000000849. Epub 2025 Sep 6.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Baxdrostat | Small molecule | — | — |
| Background | Dapagliflozin | Small molecule | 10 mg | — |