Effects of combined treatment with zibotentan and dapagliflozin compared to dapagliflozin alone in patients with diabetic and non‐diabetic chronic kidney disease
Authors' conclusion
Combination therapy with zibotentan and dapagliflozin demonstrated consistent efficacy and safety across CKD patients with and without type 2 diabetes.
Study context
- Population
- Participants with chronic kidney disease (CKD) with T2D and without T2DParticipants with CKD with T2D 261 · without T2D 186
- Participants
- 447 participants
- Comparison
- Zibotentan plus dapagliflozin vs placebo plus dapagliflozin, by T2D status
- Primary endpoint
- Change in urinary albumin-to-creatinine ratio (UACR) and markers of fluid retention (bodyweight and BNP), by T2D status
- Follow-up
- 12 weeks
Methodological detailspost hoc analysis, multicentre, double-blind, active-controlled, phase 2b
- Post hoc analysis
- Multicentre
- Double-blind
- Active-controlled
- Phase 2b
Primary result
As reported in the abstract
Change in UACR vs placebo/dapa, by diabetes status
Each group vs Placebo/dapaEstimate (90% CI)P value
Zibo/dapa 0.25/10 mg
change in UACR, without diabetes −37.7 %(−40.4 to −23.4)
p-interaction 0.096Zibo/dapa 0.25/10 mg
change in UACR, with diabetes −17.9 %(−31.3 to −2.0)
p-interaction 0.096Zibo/dapa 1.5/10 mgfirst of two printed estimates; diabetes subgroup not stated
change in UACR, consistent regardless of diabetes status −34.0 %(−45.0 to −20.8)
p-interaction 0.921Zibo/dapa 1.5/10 mgsecond of two printed estimates; diabetes subgroup not stated
change in UACR, consistent regardless of diabetes status −33.0 %(−42.2 to −22.5)
p-interaction 0.921Further findings
- Changes in body weight and BNP did not differ by diabetes status
Safety
| Outcome | Values |
|---|---|
| Fluid retention | Zibo/dapa 1.5/10 mg, with diabetes 5 events · Zibo/dapa 0.25/10 mg, with diabetes 1 events · Zibo/dapa 1.5/10 mg, without diabetes 0 events · Zibo/dapa 0.25/10 mg, without diabetes 0 events · Placebo/dapa, without diabetes 1 events · Placebo/dapa, with diabetes 0 events |
Original publication
Effects of combined treatment with zibotentan and dapagliflozin compared to dapagliflozin alone in patients with diabetic and non‐diabetic chronic kidney disease. Diabetes Obes Metab. Published 21 May 2025. doi:10.
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